Science.gov

Sample records for transdermal medical devices

  1. Development of Thin-Film Battery Powered Transdermal Medical Devices

    SciTech Connect

    Bates, J.B.; Sein, T.

    1999-07-06

    Research carried out at ORNL has led to the development of solid state thin-film rechargeable lithium and lithium-ion batteries. These unique devices can be fabricated in a variety of shapes and to any required size, large or small, on virtually any type of substrate. Because they have high energies per unit of volume and mass and because they are rechargeable, thin-film lithium batteries have potentially many applications as small power supplies in consumer and special electronic products. Initially, the objective of this project was to develop thin-film battery powered products. Initially, the objective of this project was to develop thin-film battery powered transdermal electrodes for recording electrocardiograms and electroencephalograms. These ''active'' electrode would eliminate the effect of interference and improve the reliability in diagnosing heart or brain malfunctions. Work in the second phase of this project was directed at the development of thin-film battery powered implantable defibrillators.

  2. Taro corms mucilage/HPMC based transdermal patch: an efficient device for delivery of diltiazem hydrochloride.

    PubMed

    Sarkar, Gunjan; Saha, Nayan Ranjan; Roy, Indranil; Bhattacharyya, Amartya; Bose, Madhura; Mishra, Roshnara; Rana, Dipak; Bhattacharjee, Debashis; Chattopadhyay, Dipankar

    2014-05-01

    The aim of this work is to examine the effectiveness of mucilage/hydroxypropylmethylcellulose (HPMC) based transdermal patch (matrix type) as a drug delivery device. We have successfully extracted mucilage from Colocasia esculenta (Taro) corms and prepared diltiazem hydrochloride incorporated mucilage/HPMC based transdermal patches using various wt% of mucilage by the solvent evaporation technique. Characterization of both mucilage and transdermal patches has been done by several techniques such as Molisch's test, organoleptic evaluation of mucilage, mechanical, morphological and thermal analysis of transdermal patches. Skin irritation test is studied on hairless Albino rat skin showing that transdermal patches are apparently free of potentially hazardous skin irritation. Fourier transform infrared analysis shows that there is no interaction between drug, mucilage and HPMC while scanning electron microscopy shows the surface morphology of transdermal patches. In vitro drug release time of mucilage-HPMC based transdermal patches is prolonged with increasing mucilage concentration in the formulation. PMID:24556117

  3. Micro-scale Devices for Transdermal Drug Delivery

    PubMed Central

    Arora, Anubhav; Prausnitz, Mark; Mitragotri, Samir

    2009-01-01

    Skin makes an excellent site for drug and vaccine delivery due to easy accessibility, immuno-surveillance functions, avoidance of macromolecular degradation in the gastrointestinal tract and possibility of self-administration. However, macromolecular drug delivery across the skin is primarily accomplished using hypodermic needles, which have several disadvantages including accidental needle-sticks, pain and needle phobia. These limitations have led to extensive research and development of alternative methods for drug and vaccine delivery across the skin. This review focuses on the recent trends and developments in this field of micro-scale devices for transdermal macromolecular delivery. These include liquid jet injectors, powder injectors, microneedles and thermal microablation. The historical perspective, mechanisms of action, important design parameters, applications and challenges are discussed for each method. PMID:18805472

  4. Implantable Medical Devices

    MedlinePLUS

    ... High Blood Pressure Tools & Resources Stroke More Implantable Medical Devices Updated:Sep 15,2015 For Rhythm Control ... Lifestyle Changes Recovery FAQs Medications Surgical Procedures Implantable Medical Devices Healthy Heart Quizzes • Heart Attack Tools & Resources ...

  5. Medical Device Safety

    MedlinePLUS

    A medical device is any product used to diagnose, cure, or treat a condition, or to prevent disease. They ... may need one in a hospital. To use medical devices safely Know how your device works. Keep ...

  6. Transdermal Delivery Devices: Fabrication, Mechanics and Drug Release from Silk**

    PubMed Central

    Raja, Waseem K.; MacCorkle, Scott; Diwan, Izzuddin M.; Abdurrob, Abdurrahman; Lu, Jessica; Omenetto, Fiorenzo G.; Kaplan, David L.

    2013-01-01

    Microneedles are a relatively simple, minimally invasive and painless approach to deliver drugs across the skin. However, there remain limitations with this approach because of the materials most commonly utilized for such systems. Silk protein, with tunable and biocompatibility properties, is a useful biomaterial to overcome the current limitations with microneedles. Silk devices preserve drug activity, offer superior mechanical properties and biocompatibility, can be tuned for biodegradability, and can be processed under aqueous, benign conditions. In the present work, we report the fabrication of dense microneedle arrays from silk with different drug release kinetics. The mechanical properties of the microneedle patches are tuned by post-fabrication treatments or by loading the needles with silk microparticles to increase capacity and mechanical strength. Drug release is further enhanced by the encapsulation of the drugs in the silk matrix and coating with a thin dissolvable drug layer. The microneedles are used on human cadaver skin and drugs were delivered successfully. The various attributes demonstrated suggest that silk-based microneedle devices can provide significant benefit as a platform material for transdermal drug delivery. PMID:23653252

  7. Medical devices: US medical device regulation.

    PubMed

    Jarow, Jonathan P; Baxley, John H

    2015-03-01

    Medical devices are regulated by the US Food and Drug Administration (FDA) within the Center for Devices and Radiological Health. Center for Devices and Radiological Health is responsible for protecting and promoting the public health by ensuring the safety, effectiveness, and quality of medical devices, ensuring the safety of radiation-emitting products, fostering innovation, and providing the public with accurate, science-based information about the products we oversee, throughout the total product life cycle. The FDA was granted the authority to regulate the manufacturing and marketing of medical devices in 1976. It does not regulate the practice of medicine. Devices are classified based on complexity and level of risk, and "pre-1976" devices were allowed to remain on the market after being classified without FDA review. Post-1976 devices of lower complexity and risk that are substantially equivalent to a marketed "predicate" device may be cleared through the 510(k) premarket notification process. Clinical data are typically not needed for 510(k) clearance. In contrast, higher-risk devices typically require premarket approval. Premarket approval applications must contain data demonstrating reasonable assurance of safety and efficacy, and this information typically includes clinical data. For novel devices that are not high risk, the de novo process allows FDA to simultaneously review and classify new devices. Devices that are not legally marketed are permitted to be used for clinical investigation purposes in the United States under the Investigational Device Exemptions regulation. PMID:25458071

  8. Medical Device Safety

    MedlinePLUS

    ... More Medical Device Recalls Recent Medical Device Safety Communications FDA Safety Communication Date The FDA Recommends Health Care Providers Stop ... Inc. Surgical Convenience Packs and Trays: FDA Safety Communication 01/05/16 La FDA le recomienda a ...

  9. Medication errors related to transdermal opioid patches: lessons from a regional incident reporting system

    PubMed Central

    2014-01-01

    Objective A few cases of adverse reactions linked to erroneous use of transdermal opioid patches have been reported in the literature. The aim of this study was to describe and characterize medication errors (MEs) associated with use of transdermal fentanyl and buprenorphine. Methods All events concerning transdermal opioid patches reported between 2004 and 2011 to a regional incident reporting system and assessed as MEs were scrutinized and characterized. MEs were defined as “a failure in the treatment process that leads to, or has the potential to lead to, harm to the patient”. Results In the study 151 MEs were identified. The three most common error types were wrong administration time 67 (44%), wrong dose 34 (23%), and omission of dose 20 (13%). Of all MEs, 118 (78%) occurred in the administration stage of the medication process. Harm was reported in 26 (17%) of the included cases, of which 2 (1%) were regarded as serious harm (nausea/vomiting and respiratory depression). Pain was the most common adverse reaction reported. Conclusions Of the reported MEs related to transdermal fentanyl and buprenorphine, most occurred during administration. Improved routines to ascertain correct and timely administration and educational interventions to reduce MEs for these drugs are warranted. PMID:24912424

  10. Insight: implantable medical devices.

    PubMed

    Meng, E; Sheybani, R

    2014-09-01

    Implantable electronic medical devices have achieved remarkable medical advances in the treatment of the most challenging conditions, starting with the introduction of the first implantable pacemaker in 1958. Increasing demand for innovation in existing and novel implantable devices is fuelled by the growing aging population and the increased prevalence of chronic diseases. This perspective article provides an overview of the implantable medical device ecosystem, highlights recent developments, and discusses challenges and opportunities for translation of new innovative implants enabled by microtechnologies and microfabrication. PMID:24903337

  11. Ex vivo evaluation of a microneedle array device for transdermal application.

    PubMed

    Indermun, Sunaina; Choonara, Yahya E; Kumar, Pradeep; du Toit, Lisa C; Modi, Girish; van Vuuren, Sandy; Luttge, Regina; Pillay, Viness

    2015-12-30

    A new approach of transdermal drug delivery is the use of microneedles. This promising technique offers the potential to be broadly used for drug administration as it enables the dramatic increase in permeation of medicaments across the stratum corneum. The potential of microneedles has evolved to spawn a plethora of potential transdermal applications. In order to advance the microneedle capabilities and possibly revolutionize advanced drug delivery, this study introduces a novel transdermal electro-modulated hydrogel-microneedle array (EMH-MNA) device composed of a nano-porous, embeddable ceramic microneedle array as well as an optimized EMH for the electro-responsive delivery of indomethacin through the skin. The ex vivo permeation as well as drug release experiments were performed on porcine skin tissue to ascertain the electro-responsive capabilities of the device. In addition, the microbial permeation ability of the microneedles across the viable epidermis in both microneedle-punctured skin as well as hypodermic needle-punctured skin was determined. Ex vivo evaluation of the EMH-MNA device across porcine skin demonstrated that without electro-stimulation, significantly less drug release was obtained (±0.4540mg) as compared to electro-stimulation (±2.93mg). PMID:26453791

  12. Medical Device Interoperability The lack of interoperability between medical devices

    E-print Network

    Medical Device Interoperability The lack of interoperability between medical devices can lead to preventable medical errors and potentially serious inefficiencies that could otherwise be avoided. Overview an accurate diagnostic and treatment discipline, medical devices are playing an ever-increasing role

  13. Registration of Medical Devices

    PubMed Central

    George, Bobby

    2010-01-01

    Globally the medical device (MD) market has been growing quite rapidly over the past decade. The regulatory framework for pharmaceuticals and devices differ substantially. The regulatory authorities in different regions of the world recognize different classes of medical devices (MDs), based on their design complexity, their use characteristics, and their potential for harm, if misused. With the vast majority of MDs in developing countries being imported, the respective governments need to put in place policies & regulations to address all elements related to MDs, ranging from its development, manufacturing, registration to post-marketing obligations & disposal so that public can have access to high quality, safe & affordable products for appropriate use. This article highlights current regulations pertaining to registration of MDs in India, in light of those existing in Global Harmonization Task Force (GHTF) member countries & Association of Southeast Asian Nations (ASEAN) countries. PMID:21814626

  14. Barriers to medical device innovation

    PubMed Central

    Bergsland, Jacob; Elle, Ole Jakob; Fosse, Erik

    2014-01-01

    The US Food and Drug Administration (FDA) has defined a medical device as a health care product that does not achieve it’s purpose by chemical action or by being metabolized. This means that a vast number of products are considered medical devices. Such devices play an essential role in the practice of medicine. The FDA classifies medical devices in three classes, depending on the risk of the device. Since Class I and II devices have relatively simple requirements for getting to the market, this review will focus on “implantable devices”, which, in general, belong to Class III. The European Union and Canada use a slightly different classification system. While early generations of medical devices were introduced without much testing, either technical or clinical, the process of introducing a Class III medical device from concept to clinical practice has become strongly regulated and requires extensive technological and clinical testing. The modern era of implantable medical devices may be considered to have started in the 1920s with development of artificial hips. The implantable pacemaker was another milestone and pacemakers and cardioverters/defibrillators have since saved millions of lives and created commercial giants in the medical device industry. This review will include some examples of cardiovascular devices. Similar considerations apply to the total implantable device market, although clinical and technological applications obviously vary considerably. PMID:24966699

  15. [Risk management for medical devices].

    PubMed

    Xie, Ying-jie; Xu, Xing-gang

    2007-07-01

    Based on the practices of the risk management activities by Chinese medical device manufacturers and theoretical study of the latest international standard ISO 14971:2007, this article analyses the risk management in medical device manufacturing industry by introducing the status quo of applications, four requirements at operational stages, and future trends of development. Methods and suggestions are therefore given to medical device manufacturers for risk management. PMID:17969510

  16. 78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ... HUMAN SERVICES Food and Drug Administration International Medical Device Regulators Forum; Medical... in the Medical Device Single Audit Program International Coalition Pilot Program. The Medical Device... yet thorough coverage of the diverse international regulatory requirements of medical devices...

  17. [Benefit assessment of medical devices].

    PubMed

    Zens, Yvonne; Fujita-Rohwerder, N; Windeler, J

    2015-03-01

    Medical devices play an important role in both the diagnostic and therapeutic care of patients. The hope is that particularly innovative medical devices can contribute to the improvement of patient care. However, there is no mandatory need to conduct clinical studies with medical devices that allow an assessment of their benefit within the framework of EU market access or on the way to reimbursement by the statutory health insurance (SHI) in Germany. Numerous examples show that the existing legal framework for market access and for reimbursement in the SHI system is insufficient for providing patients with only those examination and treatment methods, i. e., medical devices, that comply with the benefit requirement and the imperative for quality stipulated in the Social Code Book V. However, it is possible to conduct meaningful clinical trials, i. e., randomized controlled trials, with medical devices as well. Hence, regular, indication-related benefit assessment of medical devices with a higher risk class as a prerequisite for reimbursement for a specific medical device is not only necessary, but also feasible. The 2014 report of the Advisory Council on the Assessment of Developments in the Healthcare System contains a promising recommendation for implementing this. A regulatory framework as described in the report would allow patients the fastest possible access to safe and effective medical device innovations, while increasing planning reliability for the development and marketing of new products, which has often been criticized as insufficient by manufacturers. PMID:25566843

  18. 78 FR 15877 - Taxable Medical Devices; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ...RIN 1545-BJ44 Taxable Medical Devices; Correction AGENCY...imposed on the sale of certain medical devices, enacted by the Health Care and Education Reconciliation Act of 2010...the language ``of taxable medical device to the...

  19. Microneedles permit transdermal delivery of a skin-impermeant medication to humans

    PubMed Central

    Wermeling, Daniel P.; Banks, Stan L.; Hudson, David A.; Gill, Harvinder S.; Gupta, Jyoti; Prausnitz, Mark R.; Stinchcomb, Audra L.

    2008-01-01

    Drugs with poor oral bioavailability usually are administered by hypodermic injection, which causes pain, poor patient compliance, the need for trained personnel, and risk of infectious disease transmission. Transdermal (TD) delivery provides an excellent alternative, but the barrier of skin's outer stratum corneum (SC) prevents delivery of most drugs. Micrometer-scale microneedles (MNs) have been used to pierce animal and human cadaver skin and thereby enable TD delivery of small molecules, proteins, DNA, and vaccines for systemic action. Here, we present a clinical study of MN-enhanced delivery of a medication to humans. Naltrexone (NTX) is a potent mu-opioid receptor antagonist used to treat opiate and alcohol dependence. This hydrophilic and skin-impermeant molecule was delivered from a TD patch to healthy human subjects with and without pretreatment of the skin with MNs. Whereas delivery from a standard NTX TD patch over a 72-h period yielded undetectable drug plasma levels, pretreatment of skin with MNs achieved steady-state plasma concentrations within 2 h of patch application and were maintained for at least 48 h. The MNs and NTX patch were well tolerated with mild systemic and application site side effects. The MN arrays were painless upon administration and not damaged during skin insertion, and no MNs were broken off into the skin. This human proof-of-concept study demonstrates systemic administration of a hydrophilic medication by MN-enhanced TD delivery. These findings set the stage for future human studies of skin-impermeant medications and biopharmaceuticals for clinical applications. PMID:18250310

  20. Medical device market in China.

    PubMed

    Boyer, Philip; Morshed, Bashir I; Mussivand, Tofy

    2015-06-01

    With China's growing old-age population and economic presence on the international stage, it has become important to evaluate its domestic and foreign market contribution to medical devices. Medical devices are instruments or apparatuses used in the prevention, rehabilitation, treatment, or knowledge generation with respect to disease or other abnormal conditions. This article provides information drawn from recent publications to describe the current state of the Chinese domestic market for medical devices and to define opportunities for foreign investment potential therein. Recent healthcare reforms implemented to meet rising demand due to an aging and migrating population are having a positive effect on market growth-a global market with a projected growth of 15% per year over the next decade. PMID:25735659

  1. [Consideration of Mobile Medical Device Regulation].

    PubMed

    Peng, Liang; Yang, Pengfei; He, Weigang

    2015-07-01

    The regulation of mobile medical devices is one of the hot topics in the industry now. The definition, regulation scope and requirements, potential risks of mobile medical devices were analyzed and discussed based on mobile computing techniques and the FDA guidance of mobile medical applications. The regulation work of mobile medical devices in China needs to adopt the risk-based method. PMID:26665948

  2. Home Healthcare Medical Devices: A Checklist

    MedlinePLUS

    R Please use this checklist to use and maintain your medical device safely and effectively in your home. As a homecare medical device user, you ... home monitoring devices. Home Healthcare Medical Devices: A Checklist For additional government sources and information visit: CDRH ...

  3. 78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-15

    ...Docket No. FDA-2013-N-1306] International Medical Device Regulators Forum; Medical Device Single Audit Program International Coalition...Administration (FDA) is announcing participation in the Medical Device Single Audit Program International...

  4. 78 FR 18233 - Medical Devices; Technical Amendment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

    ..., 876, 878, 880, 882, 884, 886, 888, 890, and 892 Medical Devices; Technical Amendment AGENCY: Food and... Administration (FDA) is amending certain medical device regulations to correct minor errors in the Code of... outdated Web site addresses affecting certain regulations regarding medical devices. Publication of...

  5. Medical Devices and Systems PRECISE Center

    E-print Network

    Rajkumar, Ragunathan "Raj"

    12/16/2008 1 Medical Devices and Systems Insup Lee PRECISE Center Department Computer and Information Science University of Pennsylvania 12/15/08 CPS Information Day Medical Devices Containing recognizes that the rapidly increasing software complexity of medical devices makes the development of high

  6. 77 FR 6028 - Taxable Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-07

    ... Internal Revenue Service 26 CFR Part 48 RIN 1545-BJ44 Taxable Medical Devices AGENCY: Internal Revenue... certain medical devices under section 4191 of the Internal Revenue Code, enacted by the Health Care and... proposed regulations affect manufacturers, importers, and producers of taxable medical devices....

  7. [Buprenorphine transdermal patch (Norspan tape)].

    PubMed

    Hamaguchi, Shinsuke; Ikeda, Tomohito

    2013-07-01

    Buprenorphine is a chemically synthesized opioid characterized as the partial mu agonist and kappa antagonist, and transdermal buprenorphine patch will be considered useful as a strong analgesic with fewer psychological side effects in the treatment of chronic non-cancer pain. Use of transdermal buprenorphine should be limited for pain relief of intractable muscle skeletal pain that cannot be alleviated with other analgesics. To avoid severe complication and drug abuse or addiction, assessment of pain and medical history including drug dependence by medical team are important before administration of transdermal buprenorphine. Moreover, side effects such as nausea, vomiting, constipation, erythema and itching, loss of appetite should be treated appropriately. When transdermal buprenorphine is administered to chronic pain patients, physicians must examine the condition of patients regularly at an outpatient clinic. Moreover, decreasing and discontinuation of opioid including transdermal buprenorphine should always be considered during the treatment. Most important objective of chronic pain treatment is to improve QOL and ADL of patients. PMID:23905402

  8. Metrological Reliability of Medical Devices

    NASA Astrophysics Data System (ADS)

    Costa Monteiro, E.; Leon, L. F.

    2015-02-01

    The prominent development of health technologies of the 20th century triggered demands for metrological reliability of physiological measurements comprising physical, chemical and biological quantities, essential to ensure accurate and comparable results of clinical measurements. In the present work, aspects concerning metrological reliability in premarket and postmarket assessments of medical devices are discussed, pointing out challenges to be overcome. In addition, considering the social relevance of the biomeasurements results, Biometrological Principles to be pursued by research and innovation aimed at biomedical applications are proposed, along with the analysis of their contributions to guarantee the innovative health technologies compliance with the main ethical pillars of Bioethics.

  9. Recent developments in silicones for topical and transdermal drug delivery.

    PubMed

    Aliyar, Hyder; Schalau, Gerald

    2015-07-01

    Silicones have been used in medicines, cosmetics and medical devices for over 60 years. Polydimethylsiloxanes are polymers that are typically used either as an active in oral drug products or as excipients in topical and transdermal drug products. Inherent characteristics like hydrophobicity, adhesion and aesthetics allow silicones to offer function and performance to drug products. Recent technologies like swollen crosslinked silicone elastomer blend networks, sugar siloxanes, amphiphilic resin linear polymers and silicone hybrid pressure sensitive adhesives promise potential performance advantages and improved drug delivery efficacy. This article presents a review of recent silicone material developments focusing on their function as excipients influencing drug delivery in topical and transdermal systems. PMID:26228774

  10. Magnetically driven medical devices: a review.

    PubMed

    Sliker, Levin; Ciuti, Gastone; Rentschler, Mark; Menciassi, Arianna

    2015-11-01

    A widely accepted definition of a medical device is an instrument or apparatus that is used to diagnose, prevent or treat disease. Medical devices take a broad range of forms and utilize various methods to operate, such as physical, mechanical or thermal. Of particular interest in this paper are the medical devices that utilize magnetic field sources to operate. The exploitation of magnetic fields to operate or drive medical devices has become increasingly popular due to interesting characteristics of magnetic fields that are not offered by other phenomena, such as mechanical contact, hydrodynamics and thermodynamics. Today, there is a wide range of magnetically driven medical devices purposed for different anatomical regions of the body. A review of these devices is presented and organized into two groups: permanent magnetically driven devices and electromagnetically driven devices. Within each category, the discussion will be further segregated into anatomical regions (e.g., gastrointestinal, ocular, abdominal, thoracic, etc.). PMID:26295303

  11. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...2013-04-01 2013-04-01 false Medical image storage device. 892.2010 Section 892...Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that...

  12. 77 FR 18829 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ...Urology Devices Panel of the Medical Devices Advisory Committee...Urology Devices Panel of the Medical Devices Advisory Committee...discuss general issues related to medical devices intended for obese...placed either endoscopically (balloons and suture devices) or...

  13. 3D medical thermography device

    NASA Astrophysics Data System (ADS)

    Moghadam, Peyman

    2015-05-01

    In this paper, a novel handheld 3D medical thermography system is introduced. The proposed system consists of a thermal-infrared camera, a color camera and a depth camera rigidly attached in close proximity and mounted on an ergonomic handle. As a practitioner holding the device smoothly moves it around the human body parts, the proposed system generates and builds up a precise 3D thermogram model by incorporating information from each new measurement in real-time. The data is acquired in motion, thus it provides multiple points of view. When processed, these multiple points of view are adaptively combined by taking into account the reliability of each individual measurement which can vary due to a variety of factors such as angle of incidence, distance between the device and the subject and environmental sensor data or other factors influencing a confidence of the thermal-infrared data when captured. Finally, several case studies are presented to support the usability and performance of the proposed system.

  14. Transdermal drug delivery

    PubMed Central

    Prausnitz, Mark R.; Langer, Robert

    2009-01-01

    Transdermal drug delivery has made an important contribution to medical practice, but has yet to fully achieve its potential as an alternative to oral delivery and hypodermic injections. First-generation transdermal delivery systems have continued their steady increase in clinical use for delivery of small, lipophilic, low-dose drugs. Second-generation delivery systems using chemical enhancers, non-cavitational ultrasound and iontophoresis have also resulted in clinical products; the ability of iontophoresis to control delivery rates in real time provides added functionality. Third-generation delivery systems target their effects to skin’s barrier layer of stratum corneum using microneedles, thermal ablation, microdermabrasion, electroporation and cavitational ultrasound. Microneedles and thermal ablation are currently progressing through clinical trials for delivery of macromolecules and vaccines, such as insulin, parathyroid hormone and influenza vaccine. Using these novel second- and third-generation enhancement strategies, transdermal delivery is poised to significantly increase impact on medicine. PMID:18997767

  15. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical...

  16. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical...

  17. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...2011-04-01 2011-04-01 false Medical image communications device. 892.2020 ...Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides...

  18. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...2013-04-01 2013-04-01 false Medical image communications device. 892.2020 ...Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides...

  19. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...2014-04-01 2014-04-01 false Medical image communications device. 892.2020 ...Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides...

  20. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...2012-04-01 2012-04-01 false Medical image communications device. 892.2020 ...Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides...

  1. 78 FR 15878 - Taxable Medical Devices; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ..., 2012 (77 FR 72924). The final regulations provide guidance on the excise tax imposed on the sale of certain medical devices, enacted by the Health Care and Education Reconciliation Act of 2010 in... Internal Revenue Service 26 CFR Part 48 RIN 1545-BJ44 Taxable Medical Devices; Correction AGENCY:...

  2. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a...

  3. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a...

  4. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and...

  5. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a...

  6. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and...

  7. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and...

  8. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a...

  9. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and...

  10. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image storage device. 892.2010 Section 892...) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2010 Medical image storage device. (a) Identification. A medical image storage device is a device that provides electronic storage and...

  11. MTL ANNUAL RESEARCH REPORT 2015 Biological, Medical Devices and Systems 117 Biological, Medical Devices

    E-print Network

    Kastner, Marc A.

    MTL ANNUAL RESEARCH REPORT 2015 Biological, Medical Devices and Systems 117 Biological, Medical ........................................................................ 124 Piezoelectric Micro-machined Ultrasonic Transducer Array for Medical Imaging......................................................... 142 #12;118 Biological, Medical Devices and Systems MTL ANNUAL RESEARCH REPORT 2015 #12;MTL ANNUAL

  12. [Information safety test of digital medical device].

    PubMed

    Liu, Jiong

    2014-07-01

    According to the background of the age of big data, the medical devices are informatized, we analyze the safety and efficiency for the information and data of digital medical devices or medical systems, also discussed some test methods. Lack of a suitable standard system of digital medical devices is a big problem both for domain standard and international standard. GB25000.51 is too ambiguous and free for testing, also not very operational. So this paper suggested some test advices and some prospective method. These test methods are helpful for finding the problem and performing the standards. What's more, these methods are famous in the world and used widely in the 3C region but just start in the medical region, which can promote the development of the medical devices. PMID:25330611

  13. Privacy Challenges for Wireless Medical Devices

    SciTech Connect

    Lagesse, Brent J

    2010-01-01

    Implantable medical devices are becoming more pervasive as new technologies increase their reliability and safety. Furthermore, these devices are becoming increasingly reliant on wireless communication for interaction with the device. Such technologies have the potential to leak information that could be utilized by an attacker to threaten the lives of patients. Privacy of patient information is essential; however, this information is not the only privacy issue that must be considered. In this paper, we discuss why information privacy is insufficient for protecting patients from some attacks and how information regarding the presence of individual devices can leak vulnerabilities. Furthermore, we examine existing privacy enhancing algorithms and discuss their applicability to implantable medical devices.

  14. Anti-malware software and medical devices.

    PubMed

    2010-10-01

    Just as much as healthcare information systems, medical devices need protection against cybersecurity threats. Anti-malware software can help safeguard the devices in your facility-but it has limitations and even risks. Find out what steps you can take to manage anti-malware applications in your devices. PMID:21306047

  15. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of...

  16. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of...

  17. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of...

  18. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of...

  19. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image communications device. 892.2020... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A medical image communications device provides electronic transfer of...

  20. 21 CFR 880.6310 - Medical device data system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical device data system. 880.6310 Section 880...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Miscellaneous Devices § 880.6310 Medical device data system. (a) Identification. (1) A medical device data system...

  1. [The introduction of new medical devices].

    PubMed

    Nieuwenhuijse, Marc J; Nelissen, Rob G H H

    2015-01-01

    Regulation of the introduction of new or improved medical devices is fundamentally different from that of new drugs and is inadequate in its current form. This was recently demonstrated by large-scale problems with medical devices in various specialist fields. Steps have been taken by scientific professional associations, regulating authorities and industry to prevent these problems from happening in the future. However, these steps have not yet been implemented or have not been sufficiently well implemented, and have not been completely coordinated. The practitioner therefore needs to remain extremely critical when using new medical devices. PMID:25873221

  2. 75 FR 16347 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ...FDA-2009-N-0458] RIN 0910-AG29 Medical Devices; Pediatric Uses of Devices...the regulations on premarket approval of medical devices to include requirements relating...act requires persons who submit certain medical device applications to include...

  3. 75 FR 16365 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ...FDA-2009-N-0458] RIN 0910-AG29 Medical Devices; Pediatric Uses of Devices...the regulations on premarket approval of medical devices to include requirements relating...act requires persons who submit certain medical device applications to include...

  4. 78 FR 11612 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-19

    ...FDA-2009-N-0458] RIN 0910-AG29 Medical Devices; Pediatric Uses of Devices...the regulations on premarket approval of medical devices to include requirements relating...Act requires persons who submit certain medical device applications to include, if...

  5. Sterilization resource forecasting in the medical devices industry

    E-print Network

    Arad, Ron, 1973-

    2005-01-01

    Sterilization is an example of a procedure that has been outsourced by medical device companies. Sterilization is required for all medical devices and the process used is based on product type. As demand for medical devices ...

  6. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device...visible printed record of a medical image and associated...voluntary standards—Digital Imaging and Communications...

  7. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device...visible printed record of a medical image and associated...voluntary standards—Digital Imaging and Communications...

  8. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device...visible printed record of a medical image and associated...voluntary standards—Digital Imaging and Communications...

  9. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device...visible printed record of a medical image and associated...voluntary standards—Digital Imaging and Communications...

  10. 76 FR 45268 - Reprocessing of Reusable Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-28

    ...FDA-2011-N-0294] Reprocessing of Reusable Medical Devices AGENCY: Food and Drug Administration...affecting the reprocessing of reusable medical devices, including reprocessing quality...relates to the reprocessing of reusable medical devices, reprocessing...

  11. Seal strength models for medical device trays 

    E-print Network

    Mays, Patricia Faye

    2009-05-15

    Seven empirical equations were developed for the prediction of seal strength for medical device trays. A new methodology was developed and used for identifying burst and peel locations and comparing burst pressure and peel force. Multiple linear...

  12. Using Zigbee to integrate medical devices.

    PubMed

    Frehill, Paul; Chambers, Desmond; Rotariu, Cosmin

    2007-01-01

    Wirelessly enabling Medical Devices such as Vital Signs Monitors, Ventilators and Infusion Pumps allows central data collection. This paper discusses how data from these types of devices can be integrated into hospital systems using wireless sensor networking technology. By integrating devices you are protecting investment and opening up the possibility of networking with similar devices. In this context we present how Zigbee meets our requirements for bandwidth, power, security and mobility. We have examined the data throughputs for various medical devices, the requirement of data frequency, security of patient data and the logistics of moving patients while connected to devices. The paper describes a new tested architecture that allows this data to be seamlessly integrated into a User Interface or Healthcare Information System (HIS). The design supports the dynamic addition of new medical devices to the system that were previously unsupported by the system. To achieve this, the hardware design is kept generic and the software interface for different types of medical devices is well defined. These devices can also share the wireless resources with other types of sensors being developed in conjunction on this project such as wireless ECG (Electrocardiogram) and Pulse-Oximetry sensors. PMID:18003568

  13. 77 FR 69488 - Medical Devices; Custom Devices; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-19

    ... From the Federal Register Online via the Government Printing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Medical Devices; Custom Devices; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for comments. SUMMARY: The Food and...

  14. 21 CFR 892.2020 - Medical image communications device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2020 Medical image communications device. (a) Identification. A...

  15. Handheld Diagnostic Device Delivers Quick Medical Readings

    NASA Technical Reports Server (NTRS)

    2014-01-01

    To monitor astronauts' health remotely, Glenn Research Center awarded SBIR funding to Cambridge, Massachusetts-based DNA Medical Institute, which developed a device capable of analyzing blood cell counts and a variety of medical biomarkers. The technology will prove especially useful in rural areas without easy access to labs.

  16. 76 FR 8637 - Medical Devices; Medical Device Data Systems

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-15

    ... withdrawn, official notice of which appeared in the Federal Register on January 5, 2005 (70 FR 824 at 890... FR 7498), FDA issued a proposed rule (the proposed rule) to reclassify, upon its own initiative... functioning of the device itself. These failures can lead to inaccurate or incomplete data transfer,...

  17. Medical ice slurry production device

    DOEpatents

    Kasza, Kenneth E. (Palos Park, IL); Oras, John (Des Plaines, IL); Son, HyunJin (Naperville, IL)

    2008-06-24

    The present invention relates to an apparatus for producing sterile ice slurries for medical cooling applications. The apparatus is capable of producing highly loaded slurries suitable for delivery to targeted internal organs of a patient, such as the brain, heart, lungs, stomach, kidneys, pancreas, and others, through medical size diameter tubing. The ice slurry production apparatus includes a slurry production reservoir adapted to contain a volume of a saline solution. A flexible membrane crystallization surface is provided within the slurry production reservoir. The crystallization surface is chilled to a temperature below a freezing point of the saline solution within the reservoir such that ice particles form on the crystallization surface. A deflector in the form of a reciprocating member is provided for periodically distorting the crystallization surface and dislodging the ice particles which form on the crystallization surface. Using reservoir mixing the slurry is conditioned for easy pumping directly out of the production reservoir via medical tubing or delivery through other means such as squeeze bottles, squeeze bags, hypodermic syringes, manual hand delivery, and the like.

  18. TECHNOLOGY IN HEALTHCARE : MEDICAL DEVICES AND USER EXPERIENCES Understanding the effects of medical devices on their

    E-print Network

    Oakley, Jeremy

    TECHNOLOGY IN HEALTHCARE : MEDICAL DEVICES AND USER EXPERIENCES Understanding the effects of medical devices on their users, whether it be healthcare professionals or patients, is an important developments in healthcare. This is the aim of this research project, which is researching user behaviours

  19. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices; misleading statements. 801.6... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading statements. Among representations in the labeling of a device which render such device misbranded is a...

  20. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; misleading statements. 801.6... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading statements. Among representations in the labeling of a device which render such device misbranded is a...

  1. 77 FR 25183 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-27

    ...Administration [Docket No. FDA-2012-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

  2. 76 FR 63928 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ...Administration [Docket No. FDA-2011-N-0002] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

  3. 78 FR 49272 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-13

    ...Administration [Docket No. FDA-2013-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

  4. 78 FR 11208 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-15

    ...Administration [Docket No. FDA-2013-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

  5. 76 FR 36548 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ...Administration [Docket No. FDA-2011-N-0002] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

  6. 78 FR 67365 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-12

    ...Administration [Docket No. FDA-2013-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

  7. 77 FR 18829 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ...Administration [Docket No. FDA-2011-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

  8. 76 FR 58019 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ...Administration [Docket No. FDA-2011-N-0002] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

  9. 75 FR 7282 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-18

    ...Administration [Docket No. FDA-2010-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

  10. 76 FR 56200 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-12

    ...Administration [Docket No. FDA-2011-N-0002] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

  11. 75 FR 81282 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-27

    ...Administration [Docket No. FDA-2010-N-0001] Circulatory System Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: Circulatory System Devices Panel of the Medical Devices Advisory...

  12. 76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ...Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee...The meeting will be open to the public. Name of Committee: Immunology Devices Panel of the Medical Devices Advisory...

  13. 78 FR 26786 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-08

    ...Drug Administration [Docket No. FDA-2013-N-0001] Microbiology Devices Panel of the Medical Devices Advisory Committee...meeting will be open to the public. Name of Committee: Microbiology Devices Panel of the Medical Devices Advisory...

  14. Medical device vigilance systems: India, US, UK, and Australia

    PubMed Central

    Gupta, Pooja; Janodia, Manthan D; Jagadish, Puralea C; Udupa, Nayanabhirama

    2010-01-01

    The term medical device includes a wide category of products ranging from therapeutic medical devices exerting their effects locally such as tissue cutting, wound covering or propping open clogged arteries, to highly sophisticated computerized medical equipment and diagnostic medical devices. To achieve uniformity among the national medical device regulatory systems and increase the access to safe, effective, and clinically beneficial medical technologies, the Global Harmonization Task Force (GHTF) was conceived in 1992 by five members: European Union, United States, Australia, Japan, and Canada. All regulated countries have clearly defined medical devices, as has the GHTF. Although GHTF has tried to achieve harmonization with respect to medical devices, some differences still exist in the national laws of the countries of GHTF. Further, regulated countries have classified medical devices on the basis of their associated risk. In the Indian regulatory system, medical devices are still considered as drugs. In 2006, the Medical Device Regulation Bill was recommended to consolidate laws for medical devices and to establish the Medical Device Regulatory Authority of India. In addition, medical devices are not classified by any Indian regulatory authority. Although India has moved towards harmonizing its medical device regulations with those of regulated countries, this study aims to identify whether India should have a vigilance system in harmony with those of GHTF or develop its own system for medical devices. PMID:22915923

  15. 78 FR 15877 - Taxable Medical Devices; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ..., 2012 (77 FR 72924). The final regulations provide guidance on the excise tax imposed on the sale of... Accordingly, the final regulations (TD 9604), that are the subject of FR Doc. 2012-29628, are corrected as... Internal Revenue Service 26 CFR Part 48 RIN 1545-BJ44 Taxable Medical Devices; Correction AGENCY:...

  16. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices; expiration of exemptions. 801.127... (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medical devices; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

  17. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; expiration of exemptions. 801.127... (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medical devices; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

  18. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; expiration of exemptions. 801.127... (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medical devices; expiration of exemptions. (a) If a shipment or delivery, or any part thereof, of a device which is...

  19. Electronic medication packaging devices and medication adherence: A systematic review

    PubMed Central

    Checchi, Kyle D.; Huybrechts, Krista F.; Avorn, Jerry; Kesselheim, Aaron S.

    2014-01-01

    Importance Medication non-adherence, which has been estimated to affect 28-31% of US patients with hypertension, hyperlipidemia, and diabetes, may be improved by electronic medication packaging (EMP) devices. Objective To investigate whether EMP devices are associated with improved adherence and to identify and describe common features of EMP devices. Evidence Acquisition We systematically reviewed peer-reviewed studies testing the effectiveness of EMP systems in the MEDLINE, EMBASE, PsycINFO, CINAHL, and International Pharmaceutical Abstracts databases from searches conducted to June 13, 2014. We extracted the associations between the interventions and adherence, as well as other key findings. We assessed each study for bias using the Cochrane Handbook for Systematic Reviews of Interventions. We qualitatively assessed features of EMP devices and interventions. Results 37 studies (32 randomized and 5 non-randomized) including 4,326 patients met review criteria: 10 patient-interface-only “simple” interventions and 29 “complex” interventions integrated into the health care system (2 qualified for both categories). Overall, the effect estimates for mean adherence ranged from -2.9 to 34.0% and the effect estimates for the proportion of patients defined as adherent ranged from -8.0 to 49.5%. We identified 5 common EMP characteristics: recording dosing events and storing a record of adherence, audiovisual reminders to cue dosing, digital displays, real-time monitoring, and providing patients with adherence performance feedback. Conclusion and Relevance Many varieties of EMP exist. However, data supporting their use are limited, with variability in the quality of studies testing EMP devices and evidence of reporting bias. Devices that are integrated into the care delivery system and that are designed to record dosing events are most frequently associated with improved adherence. Higher quality evidence is needed to determine the effect, if any, of these low cost interventions on medication nonadherence and to identify their most useful components. PMID:25247520

  20. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...2013-07-01 false In-kind donations of medicine, medical devices, and medical services... § 597.511 In-kind donations of medicine, medical devices, and medical services...S. persons of in-kind donations of medicine, medical devices, and...

  1. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...2010-07-01 false In-kind donations of medicine, medical devices, and medical services... § 597.511 In-kind donations of medicine, medical devices, and medical services...S. persons of in-kind donations of medicine, medical devices, and...

  2. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...2010-07-01 false In-kind donations of medicine, medical devices, and medical services... § 595.513 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

  3. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...2012-07-01 false In-kind donations of medicine, medical devices, and medical services... § 597.511 In-kind donations of medicine, medical devices, and medical services...S. persons of in-kind donations of medicine, medical devices, and...

  4. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...2013-07-01 false In-kind donations of medicine, medical devices, and medical services... § 594.515 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

  5. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...2014-07-01 false In-kind donations of medicine, medical devices, and medical services... § 594.515 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

  6. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...2014-07-01 false In-kind donations of medicine, medical devices, and medical services... § 595.513 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

  7. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...2012-07-01 false In-kind donations of medicine, medical devices, and medical services... § 594.515 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

  8. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...2014-07-01 false In-kind donations of medicine, medical devices, and medical services... § 597.511 In-kind donations of medicine, medical devices, and medical services...S. persons of in-kind donations of medicine, medical devices, and...

  9. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...2010-07-01 false In-kind donations of medicine, medical devices, and medical services... § 594.515 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

  10. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...2012-07-01 false In-kind donations of medicine, medical devices, and medical services... § 595.513 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

  11. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...2011-07-01 false In-kind donations of medicine, medical devices, and medical services... § 595.513 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

  12. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...2011-07-01 false In-kind donations of medicine, medical devices, and medical services... § 594.515 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

  13. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...2013-07-01 false In-kind donations of medicine, medical devices, and medical services... § 595.513 In-kind donations of medicine, medical devices, and medical services...authorized to provide in-kind donations of medicine, medical devices, and...

  14. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...2011-07-01 false In-kind donations of medicine, medical devices, and medical services... § 597.511 In-kind donations of medicine, medical devices, and medical services...S. persons of in-kind donations of medicine, medical devices, and...

  15. Power Approaches for Implantable Medical Devices.

    PubMed

    Amar, Achraf Ben; Kouki, Ammar B; Cao, Hung

    2015-01-01

    Implantable medical devices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health). In this review paper, methodologies to transfer and harvest energy in implantable medical devices are introduced and discussed to highlight the uses and significances of various potential power sources. PMID:26580626

  16. Electrospun PVP-indomethacin constituents for transdermal dressings and drug delivery devices.

    PubMed

    Rasekh, Manoochehr; Karavasili, Christina; Soong, Yi Ling; Bouropoulos, Nikolaos; Morris, Mhairi; Armitage, David; Li, Xiang; Fatouros, Dimitrios G; Ahmad, Zeeshan

    2014-10-01

    A method in layering dressings with a superficial active layer of sub-micrometer scaled fibrous structures is demonstrated. For this, polyvinylpyrolidone (PVP)-indomethacin (INDO) fibres (5% w/v PVP, 5% w/w indomethacin, using a 50:50 ethanol-methanol solvent system) were produced at different flow rates (50 ?L/min and 100 ?L/min) via a modified electrospinning device head (applied voltage varied between 15 ± 2 kV). We further assessed these structures for their morphological, physical and chemical properties using SEM, AFM, DSC, XRD, FTIR and HPLC-UV. The average diameter of the resulting 3D (ca. 500 nm in height) PVP-INDO fibres produced at 50 ?L/min flow rate was 2.58 ± 0.30 ?m, while an almost two-fold increase in the diameter was observed (5.22 ± 0.83 ?m) when the flow rate was doubled. However, both of these diameters were appreciably smaller than the existing dressing fibres (ca. 30 ?m), which were visible even when layered with the active spun fibres. Indomethacin was incorporated in the amorphous state. The encapsulation efficiency was 75% w/w, with complete drug release in 45 min. The advantages are the ease of fabrication and deposition onto any existing normal or functionalised dressing (retaining the original fabric functionality), elimination of topical product issues (application, storage and transport), rapid release of active and controlled loading of drug content (fibre layer). PMID:24997411

  17. 76 FR 6625 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ... SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory Committee... be open to the public. Name of Committee: Neurological Devices Panel of the Medical Devices Advisory... related to the PMA for the Pipeline Embolization Device (PED), sponsored by Chestnut Medical. The PED...

  18. 78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ...for Early Feasibility Medical Device Clinical Studies, Including Certain First in...for Early Feasibility Medical Device Clinical Studies, Including Certain First in...feasibility studies allow for limited early clinical evaluations of devices to provide...

  19. Strategic inventory management of externally sourced medical devices

    E-print Network

    Hillstrom, Nichole L. (Nichole Leigh)

    2013-01-01

    The purpose of this research was to determine inventory strategies for externally sourced medical devices. In the medical device industry, the desire for high levels of customer service often results in less than optimal ...

  20. 76 FR 12743 - Medical Device Reporting; Malfunction Reporting Frequency

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ... From the Federal Register Online via the Government Printing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Medical Device Reporting; Malfunction Reporting Frequency AGENCY... malfunction reports in full compliance with FDA's Medical Device Reporting regulation, pending future...

  1. 76 FR 7220 - Medical Device Innovation Initiative; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-09

    ... SERVICES Food and Drug Administration Medical Device Innovation Initiative; Request for Comments AGENCY... announcing the availability of a document for public comment entitled ``Medical Device Innovation Initiative... Health (CDRH) to facilitate the development, assessment, and regulatory review of innovative...

  2. Characterization of Therapeutic Coatings on Medical Devices

    NASA Astrophysics Data System (ADS)

    Wormuth, Klaus

    Therapeutic coatings on medical devices such as catheters, guide wires, and stents improve biocompatibility by favorably altering the chemical nature of the device/tissue or device/blood interface. Such coatings often minimize tissue damage (reduce friction), decrease chances for blood clot formation (prevent platelet adsorption), and improve the healing response (deliver drugs). Confocal Raman microscopy provides valuable information about biomedical coatings by, for example, facilitating the measurement of the thickness and swelling of frictionreducing hydrogel coatings on catheters and by determining the distribution of drug within a polymer-based drug-eluting coatings on stents. This chapter explores the application of Raman microscopy to the imaging of thin coatings of cross-linked poly(vinyl pyrrolidone) gels, parylene films, mixtures of dexamethasone with various polymethacrylates, and mixtures of rapamycin with hydrolysable (biodegradable) poly(lactide-co-glycolide) polymers. Raman microscopy measures the thickness and swelling of coatings, reveals the degree of mixing of drug and polymer, senses the hydrolysis of biodegradable polymers, and determines the polymorphic forms of drug present within thin therapeutic coatings on medical devices.

  3. 77 FR 16239 - Medical Device User Fee Act; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-20

    ...Docket No. FDA-2010-N-0389] Medical Device User Fee Act; Public Meeting AGENCY...recommendations for the reauthorization of the Medical Device User Fee Act (MDUFA) for fiscal...them for the process for the review of medical device applications. The current...

  4. Medical Device Integration Copyright 2010 The University of Vermont

    E-print Network

    Hayden, Nancy J.

    Case Study Medical Device Integration Copyright© 2010 The University of Vermont Physiologic Monitor Vermont Healthcare Facility This facility consists of nearly 500 licensed beds and 13,000 medical devices. Connect medical devices to the electronic health record. Develop a system of quality assurance Solution

  5. 76 FR 24495 - Reprocessing of Reusable Medical Devices; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    ... SERVICES Food and Drug Administration Reprocessing of Reusable Medical Devices; Public Workshop AGENCY... Medical Devices Workshop.'' The purpose of the workshop is to discuss factors affecting the reprocessing of reusable medical devices and FDA's plans to address the identified issues. This workshop is...

  6. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; misleading statements. 801.6 Section 801.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices;...

  7. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; expiration of exemptions. 801.127 Section 801.127 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medical devices; expiration of exemptions. (a) If...

  8. 21 CFR 801.127 - Medical devices; expiration of exemptions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; expiration of exemptions. 801.127 Section 801.127 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.127 Medical devices; expiration of exemptions. (a) If...

  9. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; misleading statements. 801.6 Section 801.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading statements. Among representations in the labeling of...

  10. 21 CFR 801.6 - Medical devices; misleading statements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; misleading statements. 801.6 Section 801.6 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.6 Medical devices; misleading statements. Among representations in the labeling of...

  11. 77 FR 68788 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-16

    ... SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory Committee...: Neurological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... patients who have failed maximal medical management. Of note, the CoAxia NeuroFlo Catheter is identical...

  12. 78 FR 13350 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ... SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory Committee... be open to the public. Name of Committee: Ophthalmic Devices Panel of the Medical Devices Advisory... Associate Commissioner for Special Medical Programs. BILLING CODE 4160-01-P...

  13. 78 FR 77688 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-24

    ... SERVICES Food and Drug Administration Ophthalmic Devices Panel of the Medical Devices Advisory Committee... be open to the public. Name of Committee: Ophthalmic Devices Panel of the Medical Devices Advisory... Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. BILLING CODE 4160-01-P...

  14. 75 FR 36660 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-28

    ... SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices Panel of the Medical Devices... Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide.... 2). Dated: June 18, 2010. Thinh Nguyen, Acting Associate Commissioner for Special Medical...

  15. Medical Guidelines Reconciling Medical Software and Electronic Devices: Imatinib Case-study

    E-print Network

    De Micheli, Giovanni

    Medical Guidelines Reconciling Medical Software and Electronic Devices: Imatinib Case-study Alena.demicheli@epfl.ch Abstract--Nowadays medical software is tightly coupled with medical devices that perform patient state monitoring and lately even some basic treatment procedures. Medical guidelines (GLs) can be seen

  16. Hacking medical devices a review - biomed 2013.

    PubMed

    Frenger, Paul

    2013-01-01

    Programmable, implantable and external biomedical devices (such as pacemakers, defibrillators, insulin pumps, pain management pumps, vagus nerve stimulators and others) may be vulnerable to unauthorized access, commonly referred to as ?hacking?. This intrusion may lead to compromise of confidential patient data or loss of control of the device itself, which may be deadly. Risks to health from unauthorized access is in addition to hazards from faulty (?buggy?) software or circuitry. Historically, this aspect of medical device design has been underemphasized by both manufacturers and regulatory bodies until recently. However, an insulin pump was employed as a murder weapon in 2001 and successful hacking of an implantable defibrillator was demonstrated in 2008. To remedy these problems, professional groups have announced a variety of design standards and the governmental agencies of several countries have enacted device regulations. In turn, manufacturers have developed new software products and hardware circuits to assist biomedical engineering firms to improve their commercial offerings. In this paper the author discusses these issues, reviewing known problems and zero-day threats, with potential solutions. He outlines his approach to secure software and hardware challenges using the Forth language. A plausible scenario is described in which hacking of an implantable defibrillator by terrorists results in a severe national security threat to the United States. PMID:23686179

  17. 75 FR 14170 - Medical Device Epidemiology Network: Developing Partnership Between the Center for Devices and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-24

    ...FDA-2010-N-0001] Medical Device Epidemiology Network: Developing Partnership Between the Center...entitled ``Medical Device Epidemiology Network (MDEpiNet): Developing Partnership...clinically relevant expertise to establish a network that will work with FDA experts to...

  18. Integrated Microbatteries for Implantable Medical Devices

    NASA Technical Reports Server (NTRS)

    Whitacre, Jay; West, William

    2008-01-01

    Integrated microbatteries have been proposed to satisfy an anticipated need for long-life, low-rate primary batteries, having volumes less than 1 mm3, to power electronic circuitry in implantable medical devices. In one contemplated application, such a battery would be incorporated into a tubular hearing-aid device to be installed against an eardrum. This device is based on existing tube structures that have already been approved by the FDA for use in human ears. As shown in the figure, the battery would comprise a single cell at one end of the implantable tube. A small volume of Li-based primary battery cathode material would be compacted and inserted in the tube near one end, followed by a thin porous separator, followed by a pressed powder of a Li-containing alloy. Current-collecting wires would be inserted, with suitably positioned insulators to prevent a short circuit. The battery would contain a liquid electrolyte consisting of a Li-based salt in an appropriate solvent. Hermetic seals would be created by plugging both ends with a waterproof polymer followed by deposition of parylene.

  19. 77 FR 61768 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-11

    ... SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory Committee... be open to the public. Name of Committee: Neurological Devices Panel of the Medical Devices Advisory... by either surgical or endovascular intervention for patients who have failed maximal...

  20. 78 FR 66942 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ...and Rehabilitation Devices Panel of the Medical Devices Advisory...and Rehabilitation Devices Panel of the Medical Devices Advisory...because they were in commercial distribution prior to May 28, 1976, when...because they were in commercial distribution prior to May 28, 1976,...

  1. 75 FR 44273 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ... HUMAN SERVICES Food and Drug Administration Radiological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Radiological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice and recommendations...

  2. 78 FR 20328 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-04

    ... SERVICES Food and Drug Administration Orthopaedic and Rehabilitation Devices Panel of the Medical Devices... Rehabilitation Devices Panel of the Medical Devices Advisory Committee scheduled for April 5, 2013. The meeting was announced in the Federal Register of November 29, 2012 (77 FR 71195). The meeting is...

  3. 77 FR 68788 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-16

    ...Neurological Devices Panel of the Medical Devices Advisory Committee...multilumen device with two balloons mounted near the distal tip...inflation of the individual balloons. The device is placed in the...patients who have failed maximal medical management. Of note,...

  4. 77 FR 61768 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-11

    ...Neurological Devices Panel of the Medical Devices Advisory Committee...multi-lumen device with two balloons mounted near the distal tip...inflation of the individual balloons. The device is placed in the...patients who have failed maximal medical management. Of note,...

  5. 77 FR 14272 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ...FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents...part 866 is amended as follows: PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES 0 1. The authority citation for 21 CFR part...

  6. 76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ...FDA-2011-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment...part 866 is amended as follows: PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES 0 1. The authority citation for 21 CFR part...

  7. Legislative aspects of the development of medical devices.

    PubMed

    Marešová, Petra; Klímová, Blanka; Krejcar, Ond?ej; Ku?a, Kamil

    2015-09-01

    European industry of medical device technologies represents 30% of all worlds sales. New health technologies bring effective treatment approaches, help shorten stays in hospital1),bring better treatment results and accelerate rehabilitation which leads to the earlier patients recovery.Legislative aspects are one of the key areas influencing the speed of development of medical devices and their launching. The aim of this article is to specify current state of legislation in the development of medical devices in the European Union in comparison with the market leaders such as China, Japan and USA.The best established market of medical devices is in the USA. Both Japan and China follow the USA model. However, a non-professional code of ethics in China in some respect contributes to the decrease of quality of medical devices, while Japan as well as the EU countries try really hard to conform to all the regulations imposed on the manufacturing of medical devices. PMID:26459127

  8. An update on mobile phones interference with medical devices.

    PubMed

    Mahmoud Pashazadeh, Ali; Aghajani, Mahdi; Nabipour, Iraj; Assadi, Majid

    2013-10-01

    Mobile phones' electromagnetic interference with medical devices is an important issue for the medical safety of patients who are using life-supporting medical devices. This review mainly focuses on mobile phones' interference with implanted medical devices and with medical equipment located in critical areas of hospitals. A close look at the findings reveals that mobile phones may adversely affect the functioning of medical devices, and the specific effect and the degree of interference depend on the applied technology and the separation distance. According to the studies' findings and the authors' recommendations, besides mitigating interference, using mobile phones at a reasonable distance from medical devices and developing technology standards can lead to their effective use in hospital communication systems. PMID:23559585

  9. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory. (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

  10. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory. (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

  11. 21 CFR 892.2010 - Medical image storage device.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory. (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

  12. Medical devices, the FDA, and the home healthcare clinician.

    PubMed

    Simone, Lisa K; Brumbaugh, JoAnn; Ricketts, Catherine

    2014-01-01

    This article introduces the U.S. Food and Drug Administration's (FDA's) MedWatch adverse event reporting program that consumers and healthcare professionals can use to voluntarily report potential problems associated with medical devices. It discusses devices commonly used in the home and other "nonclinical" environments and suggests what clinicians can do when encountering device problems or issues. With the increasing use of medical devices in the home and other nonclinical environments, it is becoming more important for users and caregivers to participate in voluntary reporting to help the FDA best address medical device problems that may be unique to these environments. PMID:24978574

  13. 76 FR 15986 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-22

    ...University Global Medical Device Conference...University Global Medical Device Conference...affairs, and clinical research professionals, and... Using Electronic Medical Records. Cooperative Research Activities...

  14. Medical device reporting: electronic submission requirements. Final rule.

    PubMed

    2014-02-14

    The Food and Drug Administration (FDA) is revising its postmarket medical device reporting regulation and making technical corrections. This final rule requires device manufacturers and importers to submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs), to the Agency in an electronic format that FDA can process, review, and archive. Mandatory electronic reporting will improve the Agency's process for collecting and analyzing postmarket medical device adverse event information. Electronic reporting is also available to user facilities, but this rule permits user facilities to continue to submit written reports to FDA. This final rule also identifies changes to the content of required MDRs to reflect reprocessor information collected on the Form FDA 3500A as required by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). PMID:24611205

  15. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

    ...; Medical Device Classification Product Codes; Availability AGENCY: Food and Drug Administration, HHS... draft guidance entitled ``Medical Device Classification Product Codes.'' The purpose of the guidance... codes for medical devices regulated by the Center for Devices and Radiological Health (CDRH) and...

  16. 75 FR 69447 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-12

    ...Collection; Comment Request; Medical Devices; Device Tracking AGENCY...requirements for the tracking of medical devices. DATES: Submit either...for respondents involved with medical device tracking is estimated...2010. Leslie Kux, Acting Assistant Commissioner for...

  17. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

    ...applicable to manufacturers of medical devices for certain device...Agency's current thinking on medical device reporting for manufacturers...regulations.gov. To receive ``Medical Device Reporting for Manufacturers...July 1, 2013. Leslie Kux, Assistant Commissioner for...

  18. 76 FR 62419 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-07

    ...Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices Advisory...

  19. 78 FR 30928 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-23

    ...Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices Advisory...

  20. 75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ...Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee...SUMMARY: The meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory...

  1. 77 FR 20642 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-05

    ...Administration [Docket No. FDA-2012-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices Advisory...

  2. 76 FR 14415 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-16

    ...Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices Advisory...

  3. 76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-20

    ...Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee...Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory...

  4. 75 FR 49940 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-16

    ...Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee...will be open to the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices Advisory...

  5. The regulation of cognitive enhancement devices: extending the medical model

    PubMed Central

    Maslen, Hannah; Douglas, Thomas; Cohen Kadosh, Roi; Levy, Neil; Savulescu, Julian

    2014-01-01

    This article presents a model for regulating cognitive enhancement devices (CEDs). Recently, it has become very easy for individuals to purchase devices which directly modulate brain function. For example, transcranial direct current stimulators are increasingly being produced and marketed online as devices for cognitive enhancement. Despite posing risks in a similar way to medical devices, devices that do not make any therapeutic claims do not have to meet anything more than basic product safety standards. We present the case for extending existing medical device legislation to cover CEDs. Medical devices and CEDs operate by the same or similar mechanisms and pose the same or similar risks. This fact coupled with the arbitrariness of the line between treatment and enhancement count in favour of regulating these devices in the same way. In arguing for this regulatory model, the paper highlights potential challenges to its implementation, and suggests solutions. PMID:25243073

  6. Trust of Medical Devices, Applications, and Users in Pervasive Healthcare

    E-print Network

    Bishop, Matt

    Trust of Medical Devices, Applications, and Users in Pervasive Healthcare Michael Clifford Computer sources in networks of pervasive healthcare devices, sensors, and applications. Categories and Subject Descriptors J.3 [Life and Medical Sciences]: Health; C.2.0 [Computer­ Communication Networks]: General

  7. Trust of Medical Devices, Applications, and Users in Pervasive Healthcare

    E-print Network

    Bishop, Matt

    Trust of Medical Devices, Applications, and Users in Pervasive Healthcare Michael Clifford Computer sources in networks of pervasive healthcare devices, sensors, and applications. Categories and Subject Descriptors J.3 [Life and Medical Sciences]: Health; C.2.0 [Computer- Communication Networks]: General

  8. 31 CFR 561.327 - Food, medicine, and medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...2012-07-01 2012-07-01 false Food, medicine, and medical devices. 561.327...General Definitions § 561.327 Food, medicine, and medical devices. (a) The term...their derivatives. (b) The term medicine has the same meaning given the...

  9. 76 FR 44489 - Medical Devices; Neurological Devices; Classification of Repetitive Transcranial Magnetic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-26

    ... flexibility in how they meet those requirements. Cf. Papike v. Tambrands, Inc., 107 F.3d 737, 740-42 (9th Cir... SERVICES Food and Drug Administration 21 CFR Part 882 Medical Devices; Neurological Devices; Classification... distribution before May 28, 1976, the date of enactment of the Medical Device Amendments of 1976,...

  10. 76 FR 71983 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ... SERVICES Food and Drug Administration Gastroenterology and Urology Devices Panel of the Medical Devices... Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide advice... recommendations, and vote on information related to the premarket approval application, sponsored by Torax...

  11. 77 FR 14272 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-09

    ... SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and Microbiology Devices...)), devices that were not in commercial distribution before May 28, 1976, the date of enactment of the Medical... diagnosis of norovirus infection in the setting of an individual patient with symptoms of...

  12. 77 FR 50701 - Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... HUMAN SERVICES Food and Drug Administration Radiological Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Radiological Devices Panel of the Medical.... The Selenia Dimensions 3D System is currently approved for breast cancer screening and diagnosis....

  13. 77 FR 6028 - Taxable Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-07

    ...Orthopedic Devices), or 21 CFR part 892 (Radiology Devices); (2) Subpart B, Subpart...x-ray systems under 21 CFR part 892 (Radiology Devices) and product code IZL. Mobile...classified by the FDA under 21 CFR part 892 (Radiology Devices). Thus, the x-ray...

  14. Towards sustainable design for single-use medical devices.

    PubMed

    Hanson, Jacob J; Hitchcock, Robert W

    2009-01-01

    Despite their sophistication and value, single-use medical devices have become commodity items in the developed world. Cheap raw materials along with large scale manufacturing and distribution processes have combined to make many medical devices more expensive to resterilize, package and restock than to simply discard. This practice is not sustainable or scalable on a global basis. As the petrochemicals that provide raw materials become more expensive and the global reach of these devices continues into rapidly developing economies, there is a need for device designs that take into account the total life-cycle of these products, minimize the amount of non-renewable materials consumed and consider alternative hybrid reusable / disposable approaches. In this paper, we describe a methodology to perform life cycle and functional analyses to create additional design requirements for medical devices. These types of sustainable approaches can move the medical device industry even closer to the "triple bottom line"--people, planet, profit. PMID:19964137

  15. Medical Device Integration Model Based on the Internet of Things.

    PubMed

    Hao, Aiyu; Wang, Ling

    2015-01-01

    At present, hospitals in our country have basically established the HIS system, which manages registration, treatment, and charge, among many others, of patients. During treatment, patients need to use medical devices repeatedly to acquire all sorts of inspection data. Currently, the output data of the medical devices are often manually input into information system, which is easy to get wrong or easy to cause mismatches between inspection reports and patients. For some small hospitals of which information construction is still relatively weak, the information generated by the devices is still presented in the form of paper reports. When doctors or patients want to have access to the data at a given time again, they can only look at the paper files. Data integration between medical devices has long been a difficult problem for the medical information system, because the data from medical devices are lack of mandatory unified global standards and have outstanding heterogeneity of devices. In order to protect their own interests, manufacturers use special protocols, etc., thus causing medical decices to still be the "lonely island" of hospital information system. Besides, unfocused application of the data will lead to failure to achieve a reasonable distribution of medical resources. With the deepening of IT construction in hospitals, medical information systems will be bound to develop towards mobile applications, intelligent analysis, and interconnection and interworking, on the premise that there is an effective medical device integration (MDI) technology. To this end, this paper presents a MDI model based on the Internet of Things (IoT). Through abstract classification, this model is able to extract the common characteristics of the devices, resolve the heterogeneous differences between them, and employ a unified protocol to integrate data between devices. And by the IoT technology, it realizes interconnection network of devices and conducts associate matching between the data and the inspected at the device terminal in a timely manner. PMID:26628938

  16. Medical Device Integration Model Based on the Internet of Things

    PubMed Central

    Hao, Aiyu; Wang, Ling

    2015-01-01

    At present, hospitals in our country have basically established the HIS system, which manages registration, treatment, and charge, among many others, of patients. During treatment, patients need to use medical devices repeatedly to acquire all sorts of inspection data. Currently, the output data of the medical devices are often manually input into information system, which is easy to get wrong or easy to cause mismatches between inspection reports and patients. For some small hospitals of which information construction is still relatively weak, the information generated by the devices is still presented in the form of paper reports. When doctors or patients want to have access to the data at a given time again, they can only look at the paper files. Data integration between medical devices has long been a difficult problem for the medical information system, because the data from medical devices are lack of mandatory unified global standards and have outstanding heterogeneity of devices. In order to protect their own interests, manufacturers use special protocols, etc., thus causing medical decices to still be the "lonely island" of hospital information system. Besides, unfocused application of the data will lead to failure to achieve a reasonable distribution of medical resources. With the deepening of IT construction in hospitals, medical information systems will be bound to develop towards mobile applications, intelligent analysis, and interconnection and interworking, on the premise that there is an effective medical device integration (MDI) technology. To this end, this paper presents a MDI model based on the Internet of Things (IoT). Through abstract classification, this model is able to extract the common characteristics of the devices, resolve the heterogeneous differences between them, and employ a unified protocol to integrate data between devices. And by the IoT technology, it realizes interconnection network of devices and conducts associate matching between the data and the inspected at the device terminal in a timely manner. PMID:26628938

  17. MTL ANNUAL RESEARCH REPORT 2014 Biological & Medical 121 Biological, Medical Devices

    E-print Network

    Reif, Rafael

    MTL ANNUAL RESEARCH REPORT 2014 Biological & Medical 121 Biological, Medical Devices and Systems........................................................................................143 #12;122 Biological & Medical MTL ANNUAL RESEARCH REPORT 2014 #12;MTL ANNUAL RESEARCH REPORT 2014 Biological & Medical 123 Vital signs such as heart rate, blood pressure, blood ox- ygenation, cardiac output

  18. 77 FR 19534 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-02

    ...SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents; Correction AGENCY: Food and Drug Administration, HHS....

  19. 76 FR 22322 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-21

    ...SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2010-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System; Correction AGENCY: Food and Drug...

  20. Product-based Safety Certification for Medical Devices Embedded Software.

    PubMed

    Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael

    2015-01-01

    Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP). PMID:26262044

  1. A concept ideation framework for medical device design.

    PubMed

    Hagedorn, Thomas J; Grosse, Ian R; Krishnamurty, Sundar

    2015-06-01

    Medical device design is a challenging process, often requiring collaboration between medical and engineering domain experts. This collaboration can be best institutionalized through systematic knowledge transfer between the two domains coupled with effective knowledge management throughout the design innovation process. Toward this goal, we present the development of a semantic framework for medical device design that unifies a large medical ontology with detailed engineering functional models along with the repository of design innovation information contained in the US Patent Database. As part of our development, existing medical, engineering, and patent document ontologies were modified and interlinked to create a comprehensive medical device innovation and design tool with appropriate properties and semantic relations to facilitate knowledge capture, enrich existing knowledge, and enable effective knowledge reuse for different scenarios. The result is a Concept Ideation Framework for Medical Device Design (CIFMeDD). Key features of the resulting framework include function-based searching and automated inter-domain reasoning to uniquely enable identification of functionally similar procedures, tools, and inventions from multiple domains based on simple semantic searches. The significance and usefulness of the resulting framework for aiding in conceptual design and innovation in the medical realm are explored via two case studies examining medical device design problems. PMID:25956618

  2. Estradiol Transdermal Patch

    MedlinePLUS

    Most brands of estradiol transdermal patches are used to treat hot flushes (hot flashes; sudden strong feelings of heat and sweating) and/or ... life; the end of monthly menstrual periods). Transdermal estradiol is also used to prevent osteoporosis (a condition ...

  3. 75 FR 61507 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ...FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices...the notice of meeting of the General and Plastic Surgery Devices Panel of the Medical Devices...announced that a meeting of the General and Plastic Surgery Devices Panel of the Medical...

  4. 76 FR 42713 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-19

    ...FDA-2011-N-0478] General and Plastic Surgery Devices Panel of the Medical Devices...the notice of meeting of the General and Plastic Surgery Devices Panel of the Medical Devices...announced that a meeting of the General and Plastic Surgery Devices Panel of the Medical...

  5. 76 FR 71041 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-16

    ...Collection; Comment Request; Medical Device Recall Authority AGENCY: Food and Drug Administration...collection requirements for medical device recall authority. DATES: Submit either electronic...information technology. Medical Device Recall Authority--21 CFR Part 810 (OMB...

  6. 78 FR 23940 - Use of International Standard ISO-10993, “Biological Evaluation of Medical Devices Part 1...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-23

    ...evaluation of sterile and nonsterile medical devices that come into direct...Biological Evaluation of Medical Devices Part 1: Evaluation...Biological Evaluation of Medical Devices Part 1: Evaluation...April 16, 2013. Leslie Kux, Assistant Commissioner for...

  7. 77 FR 33469 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-06

    ...submitted. Form FDA 3601, the ``Medical Device User Fee Cover Sheet...administrative screening of new medical device applications and supplemental...cover sheets for the following medical device submissions (average...May 31, 2012. Leslie Kux, Assistant Commissioner for...

  8. 77 FR 52742 - Public Meeting-Strengthening the National Medical Device Postmarket Surveillance System; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ...Strengthening the National Medical Device Postmarket Surveillance...public feedback regarding the medical device postmarket surveillance...strengthening the national medical device postmarket surveillance...August 27, 2012. Leslie Kux, Assistant Commissioner for...

  9. 77 FR 52745 - Leveraging Registries With Medical Device Data for Postmarket Surveillance and Evidence Appraisal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ...use of registries with medical device data for postmarket...for using registries with medical device data for regulated...use of registries with medical device data. Dated: August 27, 2012. Leslie Kux, Assistant Commissioner for...

  10. 78 FR 12329 - Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-22

    ...have a favorable impact on medical device safety and are part...helpful in properly identifying medical device recalls and applying...receive ``Distinguishing Medical Device Recalls From Product...February 15, 2013. Leslie Kux, Assistant Commissioner for...

  11. 78 FR 21612 - Medical Device Classification Product Codes; Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-11

    ...Docket No. FDA-2011-D-0916] Medical Device Classification Product Codes...availability of the guidance entitled ``Medical Device Classification Product Codes...FDA program areas to regulate and track medical devices regulated by the Center for...

  12. 78 FR 12329 - Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-22

    ... mechanism for firms that produce and market medical devices to take timely action to correct violative... SERVICES Food and Drug Administration Distinguishing Medical Device Recalls From Product Enhancements...) is announcing the availability of the draft guidance entitled ``Distinguishing Medical Device...

  13. 77 FR 3781 - Pediatric Medical Devices; Public Workshop; Reopening of Comment Period

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

    ...of scientific research data to support pediatric medical device efficacy...ways scientific research data can be used...effectiveness claims for medical devices and pediatric...existing scientific research data to support...effectiveness claims for medical devices and...

  14. 77 FR 125 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Device Classification...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-03

    ...and Food and Drug Administration Staff; Medical Device Classification Product Codes...availability of the draft guidance entitled ``Medical Device Classification Product Codes...to use classification product codes for medical devices regulated by the Center for...

  15. 77 FR 8260 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-14

    ...; Comment Request; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor... solicits comments on medical device reporting (MDR); manufacturer, importer, user facility, and distributor... appropriate, and other forms of information technology. Medical Device Reporting: Manufacturer, Importer,...

  16. 78 FR 33849 - Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-05

    ...Docket No. FDA-2013-N-0580] Battery-Powered Medical Devices Workshop: Challenges...following public workshop entitled ``Battery-Powered Medical Devices Workshop: Challenges...awareness of the challenges related to battery-powered medical devices and...

  17. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...Brokering sales of agricultural commodities, medicine, and medical devices. 560.533...Brokering sales of agricultural commodities, medicine, and medical devices. (a) General...persons of agricultural commodities, medicine, and medical devices, provided...

  18. 31 CFR 538.526 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...Brokering sales of agricultural commodities, medicine, and medical devices. 538.526...Brokering sales of agricultural commodities, medicine, and medical devices. (a) General...persons of agricultural commodities, medicine, and medical devices to the...

  19. 31 CFR 538.526 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...Brokering sales of agricultural commodities, medicine, and medical devices. 538.526...Brokering sales of agricultural commodities, medicine, and medical devices. (a) General...persons of agricultural commodities, medicine, and medical devices to the...

  20. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...Brokering sales of agricultural commodities, medicine, and medical devices. 560.533...Brokering sales of agricultural commodities, medicine, and medical devices. (a) General...persons of agricultural commodities, medicine, and medical devices, provided...

  1. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...Brokering sales of agricultural commodities, medicine, and medical devices. 560.533...Brokering sales of agricultural commodities, medicine, and medical devices. (a) General...persons of agricultural commodities, medicine, and medical devices, provided...

  2. 75 FR 14170 - Medical Device Epidemiology Network: Developing Partnership Between the Center for Devices and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-24

    ... SERVICES Food and Drug Administration Medical Device Epidemiology Network: Developing Partnership Between... public workshop entitled ``Medical Device Epidemiology Network (MDEpiNet): Developing Partnership Between... be held at the FDA White Oak Campus, ] 10903 New Hampshire Ave., Silver Spring, MD 20993....

  3. Transdermal Photopolymerization for Minimally Invasive Implantation

    NASA Astrophysics Data System (ADS)

    Elisseeff, J.; Anseth, K.; Sims, D.; McIntosh, W.; Randolph, M.; Langer, R.

    1999-03-01

    Photopolymerizations are widely used in medicine to create polymer networks for use in applications such as bone restorations and coatings for artificial implants. These photopolymerizations occur by directly exposing materials to light in "open" environments such as the oral cavity or during invasive procedures such as surgery. We hypothesized that light, which penetrates tissue including skin, could cause a photopolymerization indirectly. Liquid materials then could be injected s.c. and solidified by exposing the exterior surface of the skin to light. To test this hypothesis, the penetration of UVA and visible light through skin was studied. Modeling predicted the feasibility of transdermal polymerization with only 2 min of light exposure required to photopolymerize an implant underneath human skin. To establish the validity of these modeling studies, transdermal photopolymerization first was applied to tissue engineering by using "injectable" cartilage as a model system. Polymer/chondrocyte constructs were injected s.c. and transdermally photopolymerized. Implants harvested at 2, 4, and 7 weeks demonstrated collagen and proteoglycan production and histology with tissue structure comparable to native neocartilage. To further examine this phenomenon and test the applicability of transdermal photopolymerization for drug release devices, albumin, a model protein, was released for 1 week from photopolymerized hydrogels. With further study, transdermal photpolymerization potentially could be used to create a variety of new, minimally invasive surgical procedures in applications ranging from plastic and orthopedic surgery to tissue engineering and drug delivery.

  4. Factors influencing the time for FDA review of medical devices

    E-print Network

    Singh, Inder Raj, S.M. Massachusetts Institute of Technology

    2007-01-01

    Companies must receive marketing authorization by the Food and Drug Administration (FDA) before they can begin commercial distribution of a new type of medical device in the United States. The premarket approval application ...

  5. Mergers and acquisitions in the medical device industry

    E-print Network

    Ohashi, Kevin Lee

    2007-01-01

    Mergers and acquisitions in the Medical Device Industry are the primary mode of exit for early stage companies. The focus of this thesis is to examine factors which influence the value of these M&A transactions from the ...

  6. Characteristics of disruptive innovation within the medical device industry

    E-print Network

    Berlin, David B. (David Benjamin)

    2011-01-01

    Innovation within the medical device industry had led to tremendous advances in the provision of care for patients worldwide. Continued progress in the treatment of disease will require effective processes for managing and ...

  7. A system theoretic approach to design safety into medical device

    E-print Network

    Song, Qingyang S.M. Massachusetts Institute of Technology

    2012-01-01

    The goal of this thesis is to investigate and demonstrate the application of a systems approach to medical device safety in China. Professor Leveson has developed an accident modeling framework called STAMP (Systems Theoretic ...

  8. Modeling medical devices for plug-and-play interoperability

    E-print Network

    Hofmann, Robert Matthew

    2007-01-01

    One of the challenges faced by clinical engineers is to support the connectivity and interoperability of medical-electrical point-of-care devices. A system that could enable plug-and-play connectivity and interoperability ...

  9. Medical Device Safety - Multiple Languages: MedlinePlus

    MedlinePLUS

    ... of All Topics All Medical Device Safety - Multiple Languages To use the sharing features on this page, please enable JavaScript. Chinese - Traditional (????) French (français) Japanese (???) Korean (???) Russian (???????) Somali (af Soomaali) Spanish (español) ...

  10. 76 FR 24495 - Reprocessing of Reusable Medical Devices; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    ...in the retention of blood, tissue, and other biological debris (soil) in reusable medical devices. This soil can allow microbes to survive the high level disinfection or sterilization process, potentially resulting in HAIs or other adverse patient...

  11. Improving supply chain agility of a medical device Manufacturer

    E-print Network

    Bai, Xinye

    2015-01-01

    This thesis focuses on a medical device manufacturer, DeCo, which offers surgical instruments to customers at no cost in order to facilitate the sale of implantable products that require the use of such instruments. DeCo ...

  12. Green manufacturing in the medical device industry : a case study

    E-print Network

    Gautreau, Leigh (Leigh Ann)

    2009-01-01

    Introduction: Med Dev (name changed to protect confidentiality), is a medical device start-up using tissue engineering and drug delivery techniques to help combat the negative effects associated with secondary injury. Med ...

  13. 77 FR 72924 - Taxable Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-07

    ... rulemaking (REG-113770-10) (the proposed regulations) in the Federal Register (77 FR 6028). The IRS and the... device'' is any device, as defined in section 201(h) of the Federal Food, Drug & Cosmetic Act (FFDCA... with the Food and Drug Administration (FDA) under section 510(j) of the FFDCA and 21 CFR part...

  14. Medical devices; medical device distributor reporting--FDA. Final rule; notification of status under the Safe Medical Devices Act; confirmation of effective date.

    PubMed

    1993-09-01

    The Food and Drug Administration (FDA) is announcing that the tentative final rule on medical device distributor reporting that appeared in the Federal Register of November 26, 1991 (56 FR 60024), is now a final rule by operation of law. This final rule requires distributors to submit reports to FDA and to manufacturers, of deaths, serious illnesses, and serious injuries related to medical devices and to submit reports to manufacturers of certain malfunctions that may cause a death, serious illness, or serious injury, if the malfunction were to recur. The final rule also changes the reporting standard for certain distributors that are importers, and changes the definition of the term "serious injury" to conform to a recent statutory amendment. In issuing this final rule, FDA is announcing that the tentative final rule relating to adverse event reporting requirements for distributors, including importers, has the status of a final rule, as of May 28, 1992, by operation of law under the Safe Medical Devices Act of 1990 (the SMDA), as amended by the Medical Device Amendments of 1992 (the 1992 amendments), and is setting forth the regulations reflecting those requirements. FDA is also amending the regulations, based on consideration of comments on the November 26, 1991, tentative final rule, to require distributors to register their facilities and to list their devices with FDA. PMID:10128335

  15. Post-approval studies in France, challenges facing medical devices.

    PubMed

    Levesque, Karine; Coqueblin, Claire; Guillot, Bernard; Aubourg, Lucie; Avouac, Bernard; Carbonneil, Cédric; Cucherat, Michel; Descamps-Mandine, Patricia; Hanoka, Serge; Goldberg, Marcel; Josseran, Anne; Parquin, François; Pitel, Séverine; Ratignier, Christelle; Sechoy, Odile; Szwarcenstein, Karine; Tanti, André; Teiger, Emmanuel; Thevenet, Nicolas

    2014-01-01

    Medical devices are characterized notably by a wide heterogeneity (from tongue depressors to hip prostheses, and from non-implantable to invasive devices), a short life cycle with recurrent incremental innovations (from 18 months to 5 years), and an operator-dependent nature. The objective of the current round table was to develop proposals and recommendations concerning the prerequisites needed in order to meet the French health authorities expectations concerning requests for post-approval studies for medical devices, required in cases where short and long-term consequences are unknown. These studies, which are the responsibility of the manufacturer or the distributor of the medical device, are designed to confirm the role of the medical device in the therapeutic management strategy in a real-life setting. There are currently approximately 150 post-approval studies underway, mainly concerning class III devices, and the majority face difficulties implementing the study or meeting the study objectives. In light of this, the round table endeavored to clearly identify the conditions for implementation of post-approval studies specific to the characteristics of medical devices. Various areas of progress have been envisaged to improve the performance of these studies, and by consequence, the efficiency of reimbursement of medical devices by the national health insurance. These include providing manufacturers with the opportunity to better anticipate post-approval requirements, defining a study-specific primary objective, integrating a phase allowing dialogue between the manufacturer, the health authorities and the scientific committee, and increasing awareness and training of health professionals on the impact of post-approval clinical studies in terms of the reimbursement of medical devices by the national insurance. PMID:25230354

  16. Development of Implantable Medical Devices: From an Engineering Perspective

    PubMed Central

    2013-01-01

    From the first pacemaker implant in 1958, numerous engineering and medical activities for implantable medical device development have faced challenges in materials, battery power, functionality, electrical power consumption, size shrinkage, system delivery, and wireless communication. With explosive advances in scientific and engineering technology, many implantable medical devices such as the pacemaker, cochlear implant, and real-time blood pressure sensors have been developed and improved. This trend of progress in medical devices will continue because of the coming super-aged society, which will result in more consumers for the devices. The inner body is a special space filled with electrical, chemical, mechanical, and marine-salted reactions. Therefore, electrical connectivity and communication, corrosion, robustness, and hermeticity are key factors to be considered during the development stage. The main participants in the development stage are the user, the medical staff, and the engineer or technician. Thus, there are three different viewpoints in the development of implantable devices. In this review paper, considerations in the development of implantable medical devices will be presented from the viewpoint of an engineering mind. PMID:24143287

  17. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false In-kind donations of medicine, medical... donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006,...

  18. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. (c) U.S. financial institutions are authorized to conduct all... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false In-kind donations of medicine, medical... § 597.511 In-kind donations of medicine, medical devices, and medical services. (a) Effective July...

  19. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false In-kind donations of medicine, medical... donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006,...

  20. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false In-kind donations of medicine, medical...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6,...

  1. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false In-kind donations of medicine, medical... donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006,...

  2. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. (c) U.S. financial institutions are authorized to conduct all... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false In-kind donations of medicine, medical... § 597.511 In-kind donations of medicine, medical devices, and medical services. (a) Effective July...

  3. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. (c) U.S. financial institutions are authorized to conduct all... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false In-kind donations of medicine, medical... § 597.511 In-kind donations of medicine, medical devices, and medical services. (a) Effective July...

  4. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false In-kind donations of medicine, medical...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6,...

  5. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false In-kind donations of medicine, medical...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6,...

  6. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false In-kind donations of medicine, medical... donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006,...

  7. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. (c) U.S. financial institutions are authorized to conduct all... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false In-kind donations of medicine, medical... § 597.511 In-kind donations of medicine, medical devices, and medical services. (a) Effective July...

  8. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false In-kind donations of medicine, medical...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6,...

  9. 75 FR 53704 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-01

    ...FDA-2010-N-0427] Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility...announced the public workshop entitled ``Medical Devices & Nanotechnology: Manufacturing, Characterization, and...

  10. SPECIAL ISSUE PAPER 1397 Swallowable medical devices for diagnosis

    E-print Network

    the additional benefit of encouraging many who currently forgo medically recommended examinations (particularlySPECIAL ISSUE PAPER 1397 Swallowable medical devices for diagnosis and surgery: the state of Mechanical Engineering, Vanderbilt University, Nashville, Tennessee, USA 2 CRIM Lab, Scuola Superiore Sant

  11. 78 FR 15878 - Taxable Medical Devices; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ...generally purchased by the general public at retail for individual use. * * * * * Example 11. * * * Accordingly, the urinary ileostomy bags are devices that are of a type that are generally purchased by the general public at retail for individual...

  12. Major Innovations and Trends in the Medical Device Sector

    PubMed Central

    Bergsland, Jacob

    2012-01-01

    Activities related to medical innovation are accelerating and becoming increasingly important due to the demand for better and less invasive therapies, a rapidly aging population in the developed world and a globally larger population able to afford advanced medical care. Medical Innovation is occurring in the fields of pharmacy, diagnostics and therapeutic imaging, surgical products, interventional procedures and devices. Increasing understanding of basic disease processes further opens the opportunities for innovators. Increased knowledge often cause major paradigm shifts in therapeutic methods. PMID:23322954

  13. Impact of the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct on medical device physician-industry collaboration

    E-print Network

    Wolf, Daniel W. (Daniel William)

    2010-01-01

    The Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (PCOC) or 105 CMR 970.000 was enacted by the Massachusetts state legislature and adopted by the Department of Public Health (DPH) in July ...

  14. 77 FR 16239 - Medical Device User Fee Act; Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-20

    ... to accommodate all persons who wish to speak. The time allotted for an individual to speak may depend... effective devices to the American people at an earlier time, and to ensure that reprocessed medical devices...-year time frame and contained two particularly important features which relate to reauthorization:...

  15. 78 FR 13347 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ... From the Federal Register Online via the Government Printing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Clinical Chemistry and Clinical Toxicology Devices Panel of... Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. General...

  16. 78 FR 26786 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-08

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Microbiology Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Microbiology Devices Panel of the...

  17. 78 FR 11208 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-15

    ... SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of the... approval application for the MitraClip Delivery System sponsored by Abbott Vascular. The system consists...

  18. 78 FR 49272 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-13

    ... SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of the... depth of compressions for the duration of CPR. On January 8, 2013 (78 FR 1162), FDA issued a...

  19. 78 FR 55081 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

    ... SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of the... Monitoring System. The CardioMEMS HF System is a permanently implantable pressure measurement system...

  20. 77 FR 16038 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ... SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of the... the premarket approval application (PMA) for the HeartWare Ventricular Assist System (HVAS)...

  1. 77 FR 18829 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... From the Federal Register Online via the Government Printing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of...

  2. 77 FR 66847 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-07

    ... SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of the... releasing external pressure during systole to reduce left ventricular workload. On March 9, 1979 (44...

  3. 78 FR 13347 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ... HUMAN SERVICES Food and Drug Administration Clinical Chemistry and Clinical Toxicology Devices Panel of... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. General...

  4. 76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    ... Federal Register of August 9, 2011 (76 FR 48871). The meeting is postponed so that FDA can review and... SERVICES Food and Drug Administration Immunology Devices Panel of the Medical Devices Advisory Committee... Food and Drug Administration (FDA) is postponing the meeting of the Immunology Devices Panel of...

  5. 78 FR 49272 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-13

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... depth of compressions for the duration of CPR. On January 8, 2013 (78 FR 1162), FDA issued a...

  6. 76 FR 56200 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-12

    ... SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of the... and are pre-loaded onto 6 or 7 Fr \\1\\ (diameter of 2 or 2.3 mm) delivery systems. Upon deployment,...

  7. 77 FR 16038 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... the premarket approval application (PMA) for the HeartWare Ventricular Assist System (HVAS)...

  8. 78 FR 11208 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-15

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... approval application for the MitraClip Delivery System sponsored by Abbott Vascular. The system consists...

  9. 78 FR 55081 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... Monitoring System. The CardioMEMS HF System is a permanently implantable pressure measurement system...

  10. 75 FR 81282 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-27

    ... SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of the... PMA supplement for the RX Acculink Carotid Stent System, sponsored by Abbott Vascular. The RX...

  11. 76 FR 58019 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ... SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of the... sponsored by AtriCure, Inc., for the AtriCure Synergy Ablation System to be used for the treatment of...

  12. 77 FR 66847 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-07

    ... HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Circulatory System Devices Panel of... releasing external pressure during systole to reduce left ventricular workload. On March 9, 1979 (44...

  13. 77 FR 71195 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-29

    ... Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To provide... Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice... July 6, 2012 (77 FR 39953), FDA issued a proposed rule which, if made final, would make...

  14. 75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ...Medical Devices; General and Plastic Surgery Devices; Classification...apparatus (e.g., reflux of waste exudate to wound, incorrect...Testing. (e.g., reflux of waste exudate to wound, incorrect...follows: PART 878--GENERAL AND PLASTIC SURGERY DEVICES 0 1. The...

  15. [Key Technology and Quantity Control of Wearable Medical Devices].

    PubMed

    Cui, Hongen; Yao, Shaowei

    2015-03-01

    In recent years, because the wearable medical devices can indicate the health monitoring index of blood sugar, blood pressure, heart rate, oxygen content, temperature, respiration of the human body anytime and anywhere, can also be used for the treatment of various diseases, accompanied by the development of large data, which will bring a subversive revolution for the medical device industry. This paper introduces the development of wearable devices, key technical index of main products, and to make a preliminary study on its quantity control. PMID:26204741

  16. Medical devices in dermatology using DLP technology from Texas Instruments

    NASA Astrophysics Data System (ADS)

    Kock, M.; Lüllau, F.

    2012-03-01

    The market of medical devices is growing continuously worldwide. With the DLP™ technology from Texas Instruments Lüllau Engineering GmbH in Germany has realized different applications in the medical discipline of dermatology. Especially a new digital phototherapy device named skintrek™ PT5 is revolutionizing the treatment of skin diseases like psoriasis , Vitiligo and other Eczema. The functions of the new phototherapy device can only be realized through DLP™ technology which is not only be used for the selective irradiation process. In combination with other optical systems DLP™ technology undertakes also other functionalities like 3D-topology calculation und patient movement compensation.

  17. Development of wearable medical device for Bio-MEMS

    NASA Astrophysics Data System (ADS)

    Nakanishi, Naoyuki; Yamamoto, Hidetake; Tsuchiya, Kazuyoshi; Uetsuji, Yasutomo; Nakamachi, Eiji

    2006-01-01

    Biomedical Micro Electro Mechanical Systems (Bio-MEMS) have been applied to the development of a variety of health care related products including health Monitoring Systems (HMS) and Drug Delivery Systems (DDS). We focus on research to develop the new type compact medical device used for blood sugar control. The new type compact medical device comprises (1) a micropump system to extract blood using a pressure change occurred by electrolysis, (2) a platinum (Pt) electrode as a blood sugar sensor immobilized Glucose Oxidase (GOx) and attached to the gate electrode of Metal-Oxide-Semiconductor Field Effect Transistor (MOSFET) to detect the amount of glucose in extracted blood, and (3) a micropump system to inject insulin using a pressure change occurred by electrolysis. The device can extract blood in a few microliter through a painless microneedle with the micropump, which used the pressure change occurred by electrolysis. The liquid extraction ability of the micropump system through a microneedle, which is 3.8 mm in length and 100 ?m in internal diameter, was measured. The wearable medical device with using the micropump controlled by electrolysis could extract human blood at the speed of 0.15 ?l/sec. If the wearable medical device extracts human blood for 6 seconds, it is enough human blood volume to measure a glucose level, compared to the amount of commercial based glucose level monitor. The compact medical device with the air bubble that occurred by electrolysis could inject insulin at the speed of 6.15?l/sec.

  18. Rotigotine Transdermal Patch

    MedlinePLUS

    ... that causes difficulties with movement, muscle control, and balance) including shaking of parts of the body, stiffness, slowed movements, and problems with balance. Rotigotine transdermal patches are also used to treat ...

  19. Rivastigmine Transdermal Patch

    MedlinePLUS

    ... also used to treat dementia in people with Parkinson's disease (a brain system disease with symptoms of ... cure Alzheimer's disease or dementia in people with Parkinson's disease. Continue to use transdermal rivastigmine even if ...

  20. Medical device development: managing conflicts of interest encountered by physicians.

    PubMed

    Baim, Donald S; Donovan, Aine; Smith, John J; Briefs, Nancy; Geoffrion, Richard; Feigal, David; Kaplan, Aaron V

    2007-04-01

    New technologies introduced over the past three decades have transformed medical diagnosis and treatment, and significantly improved patient outcomes. These changes have been mediated by the introduction of new medical devices, particularly for the treatment of cardiovascular, orthopedic, and ophthalmic disorders. These devices, in turn, have created large markets and spawned a burgeoning medical device industry, including six Fortune 500 companies whose combined market capitalization now exceeds 400 billion dollars. This success story, which has unquestionably benefited patients and society alike, has been dependent upon an intense collaboration among industry, clinicians, and regulatory authorities. However, when physicians actively involved in patient care participate in such collaborations, they are increasingly vulnerable to creating potential conflicts between these two (clinical and device development) roles. Such conflicts, which may ultimately erode public trust, have important consequences not only for the individual physicians, but also for their parent institutions, their patients, sponsoring companies, and the entire clinical research enterprise that makes the development and introduction of new devices possible. The third Dartmouth Device Development Symposium held in October 2005 brought together thought leaders within the medical device community, including academicians, clinical investigators, regulators from the Food and Drug Administration and Centers for Medicare and Medicaid Services (CMS), large and small device manufacturers and the financial (venture capital and investment banks) community. The Symposium examined the conflicts of interest encountered during the early development and commercialization of a medical device. The goal of these discussions was to (1) identify and characterize the conflicts that arise and (2) provide strategies to address these conflicts. This manuscript was prepared by a writing committee to provide a summary report of those discussions. PMID:17390305

  1. Medical device integration using mobile telecommunications infrastructure.

    PubMed

    Moorman, Bridget A; Cockle, Richard A

    2013-01-01

    Financial pressures, an aging population, and a rising number of patients with chronic diseases, have encouraged the use of remote monitoring technologies. This usually entails at least one physiological parameter measurement for a clinician. Mobile telecommunication technologies lend themselves to this functionality, and in some cases, avoid some of the issues encountered with device integration. Moreover, the inherent characteristics of the mobile telecommunications infrastructure allow a coupling of business and clinical functions that were not possible before. Table I compares and contrasts some key aspect of device integration in and out of a healthcare facility. An HTM professional may be part of the team that acquires and/or manages a system using a mobile telecommunications technology. It is important for HTM professionals to ensure the data is in a standard format so that the interfaces across this system don't become brittle and break easily if one part changes. Moreover, the security and safety considerations of the system and the data should be a primary consideration in and y purchase, with attention given to the proper environmental and encryption mechanisms. Clinical engineers and other HTM professionals are unique in that they understand the patient/clinician/device interface and the need to ensure its safety and effectiveness regardless of geographical environment. PMID:23692108

  2. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...: Medical devices. (a) General rule. CMS makes a pass-through payment for a medical device that meets the... 42 Public Health 3 2014-10-01 2014-10-01 false Transitional pass-through payments: Medical devices.... (3) Except for medical devices identified in paragraph (e) of this section, CMS determines the...

  3. 21 CFR 801.18 - Format of dates provided on a medical device label.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.18 Format of dates provided on a medical device label. (a) In general. Whenever the label of a medical device includes a printed... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Format of dates provided on a medical device...

  4. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...: Medical devices. (a) General rule. CMS makes a pass-through payment for a medical device that meets the... 42 Public Health 3 2013-10-01 2013-10-01 false Transitional pass-through payments: Medical devices.... (3) Except for medical devices identified in paragraph (e) of this section, CMS determines the...

  5. 75 FR 35495 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ...glaucoma currently treated with ocular hypotensive medication. For this device, the patients should have normal gonioscopic anatomy and a visually significant cataract eligible for phacoemulsification. The patient's glaucoma should be considered mild...

  6. Study of the in vitro cytotoxicity testing of medical devices

    PubMed Central

    LI, WEIJIA; ZHOU, JING; XU, YUYIN

    2015-01-01

    The cytotoxicity test is one of the biological evaluation and screening tests that use tissue cells in vitro to observe the cell growth, reproduction and morphological effects by medical devices. Cytotoxicity is preferred as a pilot project test and an important indicator for toxicity evaluation of medical devices as it is simple, fast, has a high sensitivity and can save animals from toxicity. Three types of cytotoxicity test are stated in the International Organization for Standardization 109993-5: Extract, direct contact and indirect contact tests. The xCELLigence real-time cell analysis system shows a significant potential in regards to cytotoxicity in recent years. The present review provides a brief insight into the in vitro cytotoxicity testing of medical devices. PMID:26405534

  7. Implantable photonic devices for improved medical treatments.

    PubMed

    Sheinman, Victor; Rudnitsky, Arkady; Toichuev, Rakhmanbek; Eshiev, Abdyrakhman; Abdullaeva, Svetlana; Egemkulov, Talantbek; Zalevsky, Zeev

    2014-01-01

    An evolving area of biomedical research is related to the creation of implantable units that provide various possibilities for imaging, measurement, and the monitoring of a wide range of diseases and intrabody phototherapy. The units can be autonomic or built-in in some kind of clinically applicable implants. Because of specific working conditions in the live body, such implants must have a number of features requiring further development. This topic can cause wide interest among developers of optical, mechanical, and electronic solutions in biomedicine. We introduce preliminary clinical trials obtained with an implantable pill and devices that we have developed. The pill and devices are capable of applying in-body phototherapy, low-level laser therapy, blue light (450 nm) for sterilization, and controlled injection of chemicals. The pill is also capable of communicating with an external control box, including the transmission of images from inside the patient’s body. In this work, our pill was utilized for illumination of the sinus-carotid zone in dog and red light influence on arterial pressure and heart rate was demonstrated. Intrabody liver tissue laser ablation and nanoparticle-assisted laser ablation was investigated. Sterilization effect of intrabody blue light illumination was applied during a maxillofacial phlegmon treatment. PMID:25279540

  8. Implantable photonic devices for improved medical treatments

    NASA Astrophysics Data System (ADS)

    Sheinman, Victor; Rudnitsky, Arkady; Toichuev, Rakhmanbek; Eshiev, Abdyrakhman; Abdullaeva, Svetlana; Egemkulov, Talantbek; Zalevsky, Zeev

    2014-10-01

    An evolving area of biomedical research is related to the creation of implantable units that provide various possibilities for imaging, measurement, and the monitoring of a wide range of diseases and intrabody phototherapy. The units can be autonomic or built-in in some kind of clinically applicable implants. Because of specific working conditions in the live body, such implants must have a number of features requiring further development. This topic can cause wide interest among developers of optical, mechanical, and electronic solutions in biomedicine. We introduce preliminary clinical trials obtained with an implantable pill and devices that we have developed. The pill and devices are capable of applying in-body phototherapy, low-level laser therapy, blue light (450 nm) for sterilization, and controlled injection of chemicals. The pill is also capable of communicating with an external control box, including the transmission of images from inside the patient's body. In this work, our pill was utilized for illumination of the sinus-carotid zone in dog and red light influence on arterial pressure and heart rate was demonstrated. Intrabody liver tissue laser ablation and nanoparticle-assisted laser ablation was investigated. Sterilization effect of intrabody blue light illumination was applied during a maxillofacial phlegmon treatment.

  9. 76 FR 48169 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-08

    ...Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices...Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...performance evaluation of highly multiplexed microbiology/medical countermeasure (MCM)...

  10. 76 FR 71982 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ...Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices...Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices...performance evaluation of highly multiplexed microbiology/medical countermeasure (MCM)...

  11. 31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. (c) U.S. financial institutions are authorized to conduct all... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine... Licensing Policy § 597.511 In-kind donations of medicine, medical devices, and medical services....

  12. 31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine....515 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6,...

  13. 31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Regulations, 15 CFR part 774, supplement no. 1. Note to paragraph (b): Nongovernmental organizations that are... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6,...

  14. 76 FR 13623 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-14

    ... establishments, Agency communications with industry, and FDA's knowledge of and experience with device labeling...; Comment Request; Medical Device Labeling Regulations AGENCY: Food and Drug Administration, HHS. ACTION... on medical device labeling regulations. DATES: Submit either electronic or written comments on...

  15. 77 FR 41417 - Regulatory Science Considerations for Medical Countermeasure Radiation Biodosimetry Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ...Considerations for Medical Countermeasure Radiation Biodosimetry Devices AGENCY: Food and...Considerations for Medical Countermeasure (MCM) Radiation Biodosimetry Devices.'' The purpose...challenges for performance validation of radiation biodosimetry devices. Date and...

  16. Securing Wireless Communication with Implanted Medical Devices using Reciprocal Carrier-Phase Quantization

    E-print Network

    Tsouri, Gill

    Securing Wireless Communication with Implanted Medical Devices using Reciprocal Carrier@rit.edu Abstract Securing wireless communication with resource- constrained implanted medical devices is considered in a resource-efficient solution for securing wireless communication with implanted devices. 1. Introduction

  17. Medical devices and procedures in the hyperbaric chamber.

    PubMed

    Kot, Jacek

    2014-12-01

    The aim of this paper is to present current controversies concerning the safety of medical devices and procedures under pressure in a hyperbaric chamber including: defibrillation in a multiplace chamber; implantable devices during hyperbaric oxygen treatment (HBOT) and the results of a recent European questionnaire on medical devices used inside hyperbaric chambers. Early electrical defibrillation is the only effective therapy for cardiac arrest caused by ventricular fibrillation or pulseless ventricular tachycardia. The procedure of defibrillation under hyperbaric conditions is inherently dangerous owing to the risk of fire, but it can be conducted safely if certain precautions are taken. Recently, new defibrillators have been introduced for hyperbaric medicine, which makes the procedure easier technically, but it must be noted that sparks and fire have been observed during defibrillation, even under normobaric conditions. Therefore, delivery of defibrillation shock in a hyperbaric environment must still be perceived as a hazardous procedure. Implantable devices are being seen with increasing frequency in patients referred for HBOT. These devices create a risk of malfunction when exposed to hyperbaric conditions. Some manufacturers support patients and medical practitioners with information on how their devices behave under increased pressure, but in some cases an individual risk-benefit analysis should be conducted on the patient and the specific implanted device, taking into consideration the patient's clinical condition, the indication for HBOT and the capability of the HBOT facility for monitoring and intervention in the chamber. The results of the recent survey on use of medical devices inside European hyperbaric chambers are also presented. A wide range of non-CE-certified equipment is used in European chambers. PMID:25596835

  18. 76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-07

    The Food and Drug Administration (FDA) is postponing the meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee scheduled for October 14, 2011. The meeting was announced in the Federal Register of August 9, 2011 (76 FR 48871). The meeting is postponed so that FDA can review and consider additional information that was submitted. Future meeting dates will be announced in......

  19. 76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... From the Federal Register Online via the Government Printing Office ] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and Microbiology... AND MICROBIOLOGY DEVICES 0 1. The authority citation for 21 CFR part 866 continues to read as...

  20. 78 FR 67365 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-12

    ... From the Federal Register Online via the Government Printing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  1. 77 FR 25183 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-27

    ... From the Federal Register Online via the Government Printing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  2. 77 FR 25183 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-27

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  3. 76 FR 36548 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... From the Federal Register Online via the Government Printing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  4. 75 FR 7282 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-18

    ... From the Federal Register Online via the Government Printing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  5. 76 FR 63928 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ... From the Federal Register Online via the Government Printing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  6. 78 FR 67365 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-12

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a...

  7. 77 FR 73034 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-07

    ... From the Federal Register Online via the Government Printing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public...

  8. 75 FR 72832 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-26

    ... From the Federal Register Online via the Government Printing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public...

  9. 76 FR 43119 - Medical Devices; General and Plastic Surgery Devices; Classification of the Focused Ultrasound...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-20

    ... SERVICES Food and Drug Administration 21 CFR Part 878 Medical Devices; General and Plastic Surgery Devices.... Exposure (Thermal Damage). Section 7: Software Validation. Section 8. Animal Testing. Section 9. Clinical... Exposure (Cavitation or Section 7. Software Validation. other Mechanical Damage). Section 8. Animal...

  10. 75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Part 878 Medical Devices; General and Plastic Surgery.... Biocompatibility. Section 7. Sterility. Material degradation Section 8. Stability and Shelf Life. ] Improper... assurance of the safety and effectiveness of the device. Therefore, on August 7, 2009, FDA issued an...

  11. 77 FR 38177 - TRICARE; Off-Label Uses of Devices; Partial List of Examples of Unproven Drugs, Devices, Medical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-27

    ...Examples of Unproven Drugs, Devices, Medical Treatments, or Procedures AGENCY: Office...for which there are demonstrations from medical literature, national organizations...accepted standards of practice in the medical community. Additionally, this rule...

  12. Medical Devices Assess, Treat Balance Disorders

    NASA Technical Reports Server (NTRS)

    2009-01-01

    You may have heard the phrase as difficult as walking and chewing gum as a joking way of referring to something that is not difficult at all. Just walking, however, is not all that simple physiologically speaking. Even standing upright is an undertaking requiring the complex cooperation of multiple motor and sensory systems including vision, the inner ear, somatosensation (sensation from the skin), and proprioception (the sense of the body s parts in relation to each other). The compromised performance of any of these elements can lead to a balance disorder, which in some form affects nearly half of Americans at least once in their lifetimes, from the elderly, to those with neurological or vestibular (inner ear) dysfunction, to athletes with musculoskeletal injuries, to astronauts returning from space. Readjusting to Earth s gravity has a significant impact on an astronaut s ability to balance, a result of the brain switching to a different "model" for interpreting sensory input in normal gravity versus weightlessness. While acclimating, astronauts can experience headaches, motion sickness, and problems with perception. To help ease the transition and study the effects of weightlessness on the body, NASA has conducted many investigations into post-flight balance control, realizing this research can help treat patients with balance disorders on Earth as well. In the 1960s, the NASA-sponsored Man Vehicle Laboratory at the Massachusetts Institute of Technology (MIT) studied the effects of prolonged space flight on astronauts. The lab s work intrigued MIT doctoral candidate Lewis Nashner, who began conducting NASA-funded research on human movement and balance under the supervision of Dr. Larry Young in the MIT Department of Aeronautics and Astronautics. In 1982, Nashner s work resulted in a noninvasive clinical technique for assessing the cooperative systems that allow the body to balance, commonly referred to as computerized dynamic posturography (CDP). CDP employs a series of dynamic protocols to isolate and assess balance function deficiencies. The technology was based on Nashner s novel, engineering-inspired concept of balance as an adaptable collaboration between multiple sensory and motor systems. CDP proved useful not only for examining astronauts, but for anyone suffering from balance problems. Today, CDP is the standard medical tool for objectively evaluating balance control.

  13. 21 CFR 892.2040 - Medical image hardcopy device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and Television Engineers (SMPTE) Test Pattern). ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image hardcopy device. 892.2040 Section 892.2040 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN...

  14. Perinatal Staff Nurse Medical Device Use and Education.

    ERIC Educational Resources Information Center

    McConnell, Edwina A.

    1998-01-01

    Survey responses from 48 perinatal nurses found that most learned about medical devices by reading manuals; 75% had received inservice training; and 95% learned from other staff. Inadequate knowledge was related to fear of causing patient harm. Initial learning method influenced what was learned, and hands-on experience was considered efficacious.…

  15. 75 FR 1395 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-11

    ...Administration [Docket No. FDA-2009-N-0606] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee...an amendment to the notice of a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory...

  16. Establishing a National Medical Device Registry in Saudi Arabia: Lessons Learned and Future Work.

    PubMed

    Al-Surimi, Khaled; Househ, Mowafa; Almohandis, Essam; Alshagathrh, Fahd

    2015-01-01

    Medical device evaluation presents several unique challenges due to the great diversity and complexity of medical devices and their rapid technological evolution. There has been a variety of work conducted on the development of disease based registries and health surveillance systems in Saudi Arabia. However, the progress of medical device registry systems and post-market medical device surveillance systems remains in its infancy in Saudi Arabia and within the region. In 2007, a royal decree assigned the responsibility for regulating medical devices to the Saudi Food and Drug Authority (SFDA). Soon afterwards, the SFDA established the Medical Devices National Registry (MDNR) to house medical device information relating to manufacturers, agents, suppliers and end-users. The aim of this paper is to provide an overview on the Medical Device National Registry (MDNR) in Saudi Arabia and describe the current experience and future work of establishing a comprehensive medical device registry and post-market surveillance system in Saudi Arabia. PMID:26152943

  17. French Sizing of Medical Devices is not Fit for Purpose

    SciTech Connect

    Kibriya, Nabil Hall, Rebecca; Powell, Steven; How, Thien; McWilliams, Richard G.

    2013-08-01

    PurposeThe purpose of the study is to quantify the variation in the metric equivalent of French size in a range of medical devices, from various manufacturers, used in interventional radiology.MethodsThe labelling of a range of catheters, introducers, drains, balloons, stents, and endografts was examined. Products were chosen to achieve a broad range of French sizes from several manufacturers. To assess manufacturing accuracy, eight devices were selected for measurement using a laser micrometer. The external diameters of three specimens of each device were measured at centimeter intervals along the length of the device to ensure uniformity.ResultsA total of 200 labels of interventional radiology equipment were scrutinized. The results demonstrate a wide variation in the metric equivalent of French sizing. Labelled products can vary in diameter across the product range by up to 0.79 mm.The devices selected for measurement with the non-contact laser micrometer demonstrate acceptable manufacturing consistency. The external diameter differed by 0.05 mm on average.ConclusionsOur results demonstrate wide variation in the interpretation of the French scale by different manufacturers of medical devices. This has the potential to lead to problems using coaxial systems especially when the products are from different manufacturers. It is recommended that standard labelling should be employed by all manufacturers conveying specific details of the equipment. Given the wide variation in the interpretation of the French scale, our opinion is that this scale either needs to be abandoned or be strictly defined and followed.

  18. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medical device... medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... reactivity of the human blood or blood component in the medical device presents no significant health...

  19. 21 CFR 801.116 - Medical devices having commonly known directions.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices having commonly known directions... SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.116 Medical devices having commonly known directions. A device shall be exempt from section 502(f)(1) of the...

  20. 21 CFR 801.116 - Medical devices having commonly known directions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices having commonly known directions... SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.116 Medical devices having commonly known directions. A device shall be exempt from section 502(f)(1) of the...

  1. 21 CFR 801.116 - Medical devices having commonly known directions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices having commonly known directions... SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.116 Medical devices having commonly known directions. A device shall be exempt from section 502(f)(1) of the...

  2. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; adequate directions for use. 801... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device...

  3. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices; adequate directions for use. 801... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device...

  4. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medical device... medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... reactivity of the human blood or blood component in the medical device presents no significant health...

  5. 21 CFR 801.15 - Medical devices; prominence of required label statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; prominence of required label... SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices... information, resulting from the use of label space for any word, statement, design, or device which is...

  6. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... devices. (a) In addition to labeling requirements in subchapter H of this chapter, when a medical device... medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... reactivity of the human blood or blood component in the medical device presents no significant health...

  7. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; adequate directions for use. 801... (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for use means directions under which the layman can use a device...

  8. 77 FR 26769 - Educational Forum on Medical Device Reporting, Complaint Files, and Recalls, Corrections, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-07

    ...Device Reporting, Complaint Files, and Recalls, Corrections, and Removals; Public...Device Reporting, Complaint Files, and Recalls, Corrections, and Removals.'' The...device reporting, (3) medical device recalls, corrections, and removals, and...

  9. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-28

    ...Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening...documents for 11 neurological and physical medicine devices. FDA is reopening the comment...documents for 11 neurological and physical medicine devices. Interested persons were...

  10. Feasibility of energy harvesting techniques for wearable medical devices.

    PubMed

    Voss, Thaddaeus J; Subbian, Vignesh; Beyette, Fred R

    2014-08-01

    Wearable devices are arguably one of the most rapidly growing technologies in the computing and health care industry. These systems provide improved means of monitoring health status of humans in real-time. In order to cope with continuous sensing and transmission of biological and health status data, it is desirable to move towards energy autonomous systems that can charge batteries using passive, ambient energy. This not only ensures uninterrupted data capturing, but could also eliminate the need to frequently remove, replace, and recharge batteries. To this end, energy harvesting is a promising area that can lead to extremely power-efficient portable medical devices. This paper presents an experimental prototype to study the feasibility of harvesting two energy sources, solar and thermoelectric energy, in the context of wearable devices. Preliminary results show that such devices can be powered by transducing ambient energy that constantly surrounds us. PMID:25570037

  11. Management information system of medical equipment using mobile devices

    NASA Astrophysics Data System (ADS)

    Núñez, C.; Castro, D.

    2011-09-01

    The large numbers of technologies currently incorporated into mobile devices transform them into excellent tools for capture and to manage the information, because of the increasing computing power and storage that allow to add many miscellaneous applications. In order to obtain benefits of these technologies, in the biomedical engineering field, it was developed a mobile information system for medical equipment management. The central platform for the system it's a mobile phone, which by a connection with a web server, it's capable to send and receive information relative to any medical equipment. Decoding a type of barcodes, known as QR-Codes, the management process is simplified and improved. These barcodes identified the medical equipments in a database, when these codes are photographed and decoded with the mobile device, you can access to relevant information about the medical equipment in question. This Project in it's actual state is a basic support tool for the maintenance of medical equipment. It is also a modern alternative, competitive and economic in the actual market.

  12. 78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ...Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for Industry, Clinical Investigators, Institutional Review...Design Considerations for Pivotal Clinical Investigations for Medical...

  13. Micro Computer Tomography for medical device and pharmaceutical packaging analysis.

    PubMed

    Hindelang, Florine; Zurbach, Raphael; Roggo, Yves

    2015-04-10

    Biomedical device and medicine product manufacturing are long processes facing global competition. As technology evolves with time, the level of quality, safety and reliability increases simultaneously. Micro Computer Tomography (Micro CT) is a tool allowing a deep investigation of products: it can contribute to quality improvement. This article presents the numerous applications of Micro CT for medical device and pharmaceutical packaging analysis. The samples investigated confirmed CT suitability for verification of integrity, measurements and defect detections in a non-destructive manner. PMID:25710902

  14. Transdermal delivery of therapeutic agent

    NASA Technical Reports Server (NTRS)

    Kwiatkowski, Krzysztof C. (Inventor); Hayes, Ryan T. (Inventor); Magnuson, James W. (Inventor); Giletto, Anthony (Inventor)

    2008-01-01

    A device for the transdermal delivery of a therapeutic agent to a biological subject that includes a first electrode comprising a first array of electrically conductive microprojections for providing electrical communication through a skin portion of the subject to a second electrode comprising a second array of electrically conductive microprojections. Additionally, a reservoir for holding the therapeutic agent surrounding the first electrode and a pulse generator for providing an exponential decay pulse between the first and second electrodes may be provided. A method includes the steps of piercing a stratum corneum layer of skin with two arrays of conductive microprojections, encapsulating the therapeutic agent into biocompatible charged carriers, surrounding the conductive microprojections with the therapeutic agent, generating an exponential decay pulse between the two arrays of conductive microprojections to create a non-uniform electrical field and electrokinetically driving the therapeutic agent through the stratum corneum layer of skin.

  15. 76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-20

    ... Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for December 1, 2011. The meeting was announced in the Federal Register of Friday, October 7, 2011 (76 FR 62419). The... SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical...

  16. 76 FR 42713 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-19

    ... Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of July 7, 2011 (76 FR 39882). The amendment is being made to reflect a change in the... SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical...

  17. 75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... Register of June 24, 2010 (75 FR 36102). The meeting is postponed so that FDA can review and consider... SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical Devices...: Notice. SUMMARY: The meeting of the General and Plastic Surgery Devices Panel of the Medical...

  18. 75 FR 61507 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-05

    ... Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of August 16, 2010 (75 FR 49940). The amendment is being made to reflect a change in the... SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical...

  19. Printable thermoelectric devices and conductive patterns for medical applications

    NASA Astrophysics Data System (ADS)

    Lee, Jungmin; Kim, Hyunjung; Chen, Linfeng; Choi, Sang H.; Varadan, Vijay K.

    2012-10-01

    Remote point-of-care is expected to revolutionize the modern medical practice, and many efforts have been made for the development of wireless health monitoring systems for continuously detecting the physiological signals of patients. To make the remote point-of-care generally accepted and widely used, it is necessary to develop cost-effective and durable wireless health monitoring systems. Printing technique will be helpful for the fabrication of high-quality and low-cost medical devices and systems because it allows high-resolution and high-speed fabrication, low material consumption and nano-sized patterning on both flexible and rigid substrates. Furthermore, application of thermoelectric generators can replace conventional batteries as the power sources for wireless health monitoring systems because thermoelectric generators can convert the wasted heat or the heat from nature into electricity which is required for the operation of the wireless health monitoring systems. In this research, we propose the concept of printable thermoelectric devices and conductive patterns for the realization of more portable and cost-effective medical devices. To print thermoelectric generators and conductive patterns on substrates, printing inks with special characteristics should be developed. For the development of thermoelectric inks, nano-structured thermoelectric materials are synthesized and characterized; and for the development of conductive inks, two kinds of surface treated carbon nanotubes are used as active materials.

  20. 77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ...Administration/Xavier University Global Medical Device Conference...FDA/Xavier University Global Medical Device Conference...conference is intended for companies of all sizes and employees...Promotional Practices--Global; Office of Compliance... Global Regulatory Strategy; and FDA...

  1. 76 FR 17657 - Medical Device Epidemiology Network 2011: Second Annual Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-30

    ...FDA-2011-N-0002] Medical Device Epidemiology Network 2011: Second Annual Public...workshop entitled ``Medical Device Epidemiology Network (MDEpiNet) 2011: Second...all stakeholders with expertise in epidemiology and health services research on...

  2. 78 FR 46970 - Medical Device User Fee Rates for Fiscal Year 2014

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-02

    ...FDA-2013-N-0007] Medical Device User Fee Rates for Fiscal Year 2014 AGENCY: Food and...Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2014. The Federal...

  3. 76 FR 45826 - Medical Device User Fee Rates for Fiscal Year 2012

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-01

    ...FDA-2011-N-0542] Medical Device User Fee Rates for Fiscal Year 2012 AGENCY: Food and...Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2012. The Federal...

  4. 77 FR 45359 - Medical Device User Fee Rates for Fiscal Year 2013

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-31

    ...FDA-2012-N-0785] Medical Device User Fee Rates for Fiscal Year 2013 AGENCY: Food and...Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2013. The Federal...

  5. 75 FR 8375 - Device Improvements to Reduce Unnecessary Radiation Exposure From Medical Imaging; Public Meeting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-24

    ...Device Improvements to Reduce Unnecessary Radiation Exposure From Medical Imaging; Public...Device Improvements to Reduce Unnecessary Radiation Exposure From Medical Imaging.'' The...unnecessary patient exposure to ionizing radiation during CT and fluoroscopic...

  6. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... false Medical devices; Spanish-language version of certain required statements...801.16 Medical devices; Spanish-language version of certain required statements...Rico where Spanish is the predominant language, such labeling is authorized...

  7. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... false Medical devices; Spanish-language version of certain required statements...801.16 Medical devices; Spanish-language version of certain required statements...Rico where Spanish is the predominant language, such labeling is authorized...

  8. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... false Medical devices; Spanish-language version of certain required statements...801.16 Medical devices; Spanish-language version of certain required statements...Rico where Spanish is the predominant language, such labeling is authorized...

  9. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... false Medical devices; Spanish-language version of certain required statements...801.16 Medical devices; Spanish-language version of certain required statements...Rico where Spanish is the predominant language, such labeling is authorized...

  10. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... false Medical devices; Spanish-language version of certain required statements...801.16 Medical devices; Spanish-language version of certain required statements...Rico where Spanish is the predominant language, such labeling is authorized...

  11. 76 FR 77834 - Scientific Information Request on Intravascular Diagnostic and Imaging Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-14

    ... Tomography (OCT), Near- Infrared Spectroscopy (NIR), Angioscopy, Intravascular Magnetic Resonance Imaging... Diagnostic and Imaging Medical Devices AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION... imaging medical devices, including: Fractional Flow Reserve (FFR), Coronary Flow Reserve...

  12. Inductively Heated Shape Memory Polymer for the Magnetic Actuation of Medical Devices

    E-print Network

    Buckley, Patrick R.

    2007-01-23

    Presently there is interest in making medical devices such as expandable stents and intravascular microactuators from shape memory polymer (SMP). One of the key challenges in realizing SMP medical devices is the implementation ...

  13. 31 CFR 538.526 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Brokering commercial sales of agricultural commodities, medicine, and medical devices. 538.526 Section 538.526 ...Brokering commercial sales of agricultural commodities, medicine, and medical devices. (a) General license for...

  14. 31 CFR 538.526 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Brokering commercial sales of agricultural commodities, medicine, and medical devices. 538.526 Section 538.526 ...Brokering commercial sales of agricultural commodities, medicine, and medical devices. (a) General license for...

  15. 31 CFR 561.327 - Agricultural commodities, food, medicine, and medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...false Agricultural commodities, food, medicine, and medical devices. 561.327...327 Agricultural commodities, food, medicine, and medical devices. (a) The term...their derivatives. (c) The term medicine has the same meaning given the...

  16. 31 CFR 538.526 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Brokering commercial sales of agricultural commodities, medicine, and medical devices. 538.526 Section 538.526 ...Brokering commercial sales of agricultural commodities, medicine, and medical devices. (a) General license for...

  17. 31 CFR 560.533 - Brokering commercial sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... Brokering commercial sales of agricultural commodities, medicine, and medical devices. 560.533 Section 560.533 ...Brokering commercial sales of agricultural commodities, medicine, and medical devices. (a) General license for...

  18. Materials Advances for Next-Generation Ingestible Electronic Medical Devices.

    PubMed

    Bettinger, Christopher J

    2015-10-01

    Electronic medical implants have collectively transformed the diagnosis and treatment of many diseases, but have many inherent limitations. Electronic implants require invasive surgeries, operate in challenging microenvironments, and are susceptible to bacterial infection and persistent inflammation. Novel materials and nonconventional device fabrication strategies may revolutionize the way electronic devices are integrated with the body. Ingestible electronic devices offer many advantages compared with implantable counterparts that may improve the diagnosis and treatment of pathologies ranging from gastrointestinal infections to diabetes. This review summarizes current technologies and highlights recent materials advances. Specific focus is dedicated to next-generation materials for packaging, circuit design, and on-board power supplies that are benign, nontoxic, and even biodegradable. Future challenges and opportunities are also highlighted. PMID:26403162

  19. 76 FR 22322 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-21

    ... correcting a final rule that appeared in the Federal Register of March 23, 2011 (76 FR 16292). The document... Spring, MD 20993-0002, 301-796-9148. SUPPLEMENTARY INFORMATION: In FR Doc. 2011-6620, appearing on page... SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and Microbiology...

  20. 77 FR 19534 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-02

    ...: Final rule; correction. SUMMARY: In the Federal Register of March 9, 2012 (76 FR 14272), the Food and.... SUPPLEMENTARY INFORMATION: In FR Doc. 2012-5675 appearing on page 14272 in the Federal Register of Friday, March... SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Immunology and Microbiology...

  1. 75 FR 16347 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... November 21, 1997 (62 FR 62466), FDA announced the availability of the guidance document entitled..., using existing filing, storage, and data management systems and processes. VIII. How Does the Paperwork... SERVICES Food and Drug Administration 21 CFR Part 814 RIN 0910-AG29 Medical Devices; Pediatric Uses...

  2. 75 FR 16365 - Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... significant adverse comment. In the Federal Register of November 21, 1997 (62 FR 62466), you can find... integral part of each submission, using existing filing, storage, and data management systems and processes... SERVICES Food and Drug Administration 21 CFR Part 814 RIN 0910-AG29 Medical Devices; Pediatric Uses...

  3. 75 FR 35495 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-22

    ... Glaukos Corp. The device is indicated for use in conjunction with cataract surgery for the reduction of... medications and patients should not previously have had surgery for glaucoma. FDA intends to make background... the committee. Written submissions may be made to the contact person on or before July 22, 2010....

  4. 78 FR 23940 - Use of International Standard ISO-10993, “Biological Evaluation of Medical Devices Part 1...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-23

    ... Evaluation of Medical Devices Part 1: Evaluation and Testing''; Draft Guidance for Industry and Food and Drug... International Standard ISO-10993, `Biological Evaluation of Medical Devices Part 1: Evaluation and Testing...(k)s), and de novo requests for medical devices that come into direct or indirect contact with...

  5. 76 FR 7222 - Medical Device Innovation Initiative; Public Meeting; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-09

    ... HUMAN SERVICES Food and Drug Administration Medical Device Innovation Initiative; Public Meeting... ``CDRH's Medical Device Innovation Initiative Public Workshop.'' The purpose of the public meeting is to...) document, ``Medical Device Innovation Initiative'' (report). FDA is seeking input on a number of...

  6. 76 FR 18227 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-01

    ...FDA-2011-N-0066] Molecular and Clinical Genetics Panel of the Medical Devices Advisory...meeting of the Molecular and Clinical Genetics Panel (the panel) of the Medical Devices...meeting of the Molecular and Clinical Genetics Panel of the Medical Devices...

  7. 75 FR 45641 - Medical Device User Fee Rates for Fiscal Year 2011

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ...No. FDA-2010-N-0363] Medical Device User Fee Rates for Fiscal...and payment procedures for medical device user fees for fiscal...not for any other aspects of medical device user fees.) Problems...2010. Leslie Kux, Acting Assistant Commissioner for...

  8. 78 FR 12067 - Extreme Weather Effects on Medical Device Safety and Quality

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

    ...Extreme Weather Effects on Medical Device Safety and Quality AGENCY...weather and natural disasters on medical device safety and quality...minimize temporary shortages of medical devices when EW may damage...February 14, 2013. Leslie Kux, Assistant Commissioner for...

  9. 77 FR 3781 - Pediatric Medical Devices; Public Workshop; Reopening of Comment Period

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-25

    ... materials. The current medical device market for children has a higher demand than supply. FDA is committed... SERVICES Food and Drug Administration Pediatric Medical Devices; Public Workshop; Reopening of Comment... notice entitled ``Pediatric Medical Devices; Public Workshop; Request for Comments'' that appeared in...

  10. 76 FR 67463 - Pediatric Medical Devices; Public Workshop; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-01

    ... exposure to implanted materials. The current medical device market for children has a higher demand than... SERVICES Food and Drug Administration Pediatric Medical Devices; Public Workshop; Request for Comments... Data to Support Pediatric Medical Device Claims: A Public Dialogue.'' The purpose of the...

  11. 77 FR 27234 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-09

    ...; Comment Request; Medical Devices; Inspection by Accredited Persons Program AGENCY: Food and Drug... notice solicits comments on the Inspection by Accredited Persons Program Under the Medical Device User... Medical Device User Fee and Modernization Act of 2002--(OMB Control Number 0910-0510)-- Extension...

  12. 75 FR 77647 - Medical Device User Fee Program; Meetings on Reauthorization; Request for Notification of Patient...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-13

    ... SERVICES Food and Drug Administration Medical Device User Fee Program; Meetings on Reauthorization; Request... their intent to participate in periodic consultation meetings on reauthorization of the Medical Device... FDA to continue collecting user fees for the medical device program. The Federal Food, Drug,...

  13. Home Use Medical Devices: The Impact on the Lives of Older People

    E-print Network

    Oakley, Jeremy

    Home Use Medical Devices: The Impact on the Lives of Older People Background Increased life were carried out with medical device users aged 65 or over. Five of these interviews included' illustrated the interaction of medical devices on the environment and context of its use. Conclusion

  14. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; adequate directions for use. 801.5 Section 801.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for...

  15. 21 CFR 801.15 - Medical devices; prominence of required label statements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; prominence of required label statements. 801.15 Section 801.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices; prominence of required label statements....

  16. 21 CFR 801.5 - Medical devices; adequate directions for use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; adequate directions for use. 801.5 Section 801.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.5 Medical devices; adequate directions for use. Adequate directions for...

  17. 21 CFR 801.116 - Medical devices having commonly known directions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices having commonly known directions. 801.116 Section 801.116 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.116 Medical devices having commonly known...

  18. 21 CFR 801.15 - Medical devices; prominence of required label statements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; prominence of required label statements. 801.15 Section 801.15 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.15 Medical devices; prominence of required label statements....

  19. 21 CFR 801.116 - Medical devices having commonly known directions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices having commonly known directions. 801.116 Section 801.116 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.116 Medical devices having commonly known...

  20. 77 FR 33469 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-06

    ...; Comment Request; Medical Device User Fee Cover Sheet, Form FDA 3601 AGENCY: Food and Drug Administration... solicits comments on Form FDA 3601, entitled ``Medical Device User Fee Cover Sheet,'' which must be... appropriate, and other forms of information technology. Medical Device User Fee Cover Sheet--Form FDA...

  1. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... commodities, medicine, and medical devices. 560.533 Section 560.533 Money and Finance: Treasury Regulations... Policy § 560.533 Brokering sales of agricultural commodities, medicine, and medical devices. (a) General... agricultural commodities, medicine, and medical devices, provided that the sale and exportation...

  2. 31 CFR 560.533 - Brokering sales of agricultural commodities, medicine, and medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... commodities, medicine, and medical devices. 560.533 Section 560.533 Money and Finance: Treasury Regulations... Policy § 560.533 Brokering sales of agricultural commodities, medicine, and medical devices. (a) General... of agricultural commodities, medicine, and medical devices, provided that the sale and exportation...

  3. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Transitional pass-through payments: Medical devices... DEPARTMENT SERVICES Transitional Pass-through Payments § 419.66 Transitional pass-through payments: Medical devices. (a) General rule. CMS makes a pass-through payment for a medical device that meets...

  4. 42 CFR 419.66 - Transitional pass-through payments: Medical devices.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 3 2011-10-01 2011-10-01 false Transitional pass-through payments: Medical devices... DEPARTMENT SERVICES Transitional Pass-through Payments § 419.66 Transitional pass-through payments: Medical devices. (a) General rule. CMS makes a pass-through payment for a medical device that meets...

  5. Transmitting patient and device data via GSM--central management for decentral mobile medical devices.

    PubMed

    Bachmor, T; Schöchlin, J; Bolz, A

    2002-01-01

    Equipping medical devices with long range telemetry opens completely new possibilities for emergency response, home care and remote diagnosis. Mobile communications nowadays seem to be a generally accepted part of our modern world, but bridging the gap between new (consumer-) technologies and medical devices still is a challenge today. Providing a telemetry link (GSM) is just the trivial part--ensuring security, reliability and service management are the more critical tasks that need to be addressed. Therefore, a complete system concept consists of an automatic fleet management (e.g. periodic device-initiated service calls) as well as customer relationship management (CRM), including technical service and a trouble-ticket system. PMID:12451860

  6. 34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...and external components of surgically implanted medical devices. 300.113 Section...and external components of surgically implanted medical devices. (a) Hearing aids...b) External components of surgically implanted medical devices. (1) Subject...

  7. 34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...surgically implanted medical devices. 300...Section 300.113 Education Regulations of...surgically implanted medical devices are functioning...surgically implanted medical device who is receiving special education and related...

  8. 34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...surgically implanted medical devices. 300...Section 300.113 Education Regulations of...surgically implanted medical devices are functioning...surgically implanted medical device who is receiving special education and related...

  9. 34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...surgically implanted medical devices. 300...Section 300.113 Education Regulations of...surgically implanted medical devices are functioning...surgically implanted medical device who is receiving special education and related...

  10. 34 CFR 300.113 - Routine checking of hearing aids and external components of surgically implanted medical devices.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...surgically implanted medical devices. 300...Section 300.113 Education Regulations of...surgically implanted medical devices are functioning...surgically implanted medical device who is receiving special education and related...

  11. 76 FR 24494 - Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    ...Reprocessing Medical Devices in Health Care Settings: Validation Methods and...Reprocessing Medical Devices in Health Care Settings: Validation Methods and...Reprocessing Medical Devices in Health Care Settings: Validation Methods...

  12. 77 FR 41413 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-13

    ...Drug Administration Staff; Medical Devices: The Pre-Submission...Pre-Submission program for medical devices reviewed in CDRH and...information. Respondents are medical device manufacturers subject...July 9, 2012. Leslie Kux, Assistant Commissioner for...

  13. 77 FR 52741 - MDEpiNet 2012 Annual Meeting: The Medical Device Epidemiology Network as a Partnership for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-30

    ...community on issues related to medical device epidemiology methodology...epidemiologic understanding of medical devices and procedures. II...MDEpiNet as a framework for medical device postmarket surveillance...August 27, 2012. Leslie Kux, Assistant Commissioner for...

  14. 21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...requirements for medical devices held...appropriate FDA Center Director may grant...other units of a medical device, if the Center Director determines...units of the medical device subject...by the Center Director in support...

  15. 76 FR 34845 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-15

    ... Drug Administration 21 CFR Part 874 Medical Devices; Ear, Nose, and Throat Devices; Classification of... to the Commissioner of Food and Drugs, 21 CFR part 874 is amended as follows: PART 874--EAR,...

  16. 78 FR 21612 - Medical Device Classification Product Codes; Guidance for Industry and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-11

    ... unclassified devices and devices not yet classified. In the Federal Register of January 3, 2012 (77 FR 125... HUMAN SERVICES Food and Drug Administration Medical Device Classification Product Codes; Guidance for... guidance entitled ``Medical Device Classification Product Codes.'' This document describes how...

  17. 77 FR 43846 - Food and Drug Administration Pediatric Medical Devices Workshop; Notice of Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-26

    ... FDA. The goal of this meeting is to engage and educate pediatric innovators and device industry... SERVICES Food and Drug Administration Food and Drug Administration Pediatric Medical Devices Workshop... Medical Devices Workshop. This meeting is intended to focus on challenges in pediatric device...

  18. 75 FR 47604 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ...Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period; Correction...of draft guidance documents for 11 neurological and physical medicine devices. The document was published with an inadvertent...

  19. Therapeutic transdermal drug innovation from 2000 to 2014: current status and outlook.

    PubMed

    Walter, Jessica R; Xu, Shuai

    2015-11-01

    The US Food and Drug Administration (FDA) approved the first transdermal drug over 35 years ago. Today, transdermal products represent a growing, multibillion dollar market. From 2000 to 2014, an average of 2.6 new transdermal drug were approved each year. However, only two of these approvals represented new molecular entities (NMEs). Furthermore, none of these approvals were designated for priority review by the FDA. Currently, transdermal drugs are limited in scope to fewer than 20 clinical indications. The past decade has seen significant safety, performance, and cost issues surrounding multiple transdermal drug products. As the field moves towards more complex drug-device combinations to overcome the natural barrier function of the skin, there will likely be more regulatory challenges, but also the potential for broader clinical scope. PMID:26116094

  20. Assessment and non-clinical impact of medical devices.

    PubMed

    Dervaux, Benoît; Szwarcensztein, Karine; Josseran, Anne; Barna, Alexandre; Carbonneil, Cédric; Chevrie, Karine; Debroucker, Frédérique; Grumblat, Anne; Grumel, Olivier; Massol, Jacques; Maugendre, Philippe; Méchin, Hubert; Orlikowski, David; Roussel, Christophe; Rumeau-Pichon, Catherine; Sales, Jean-Patrick; Vicaut, Eric

    2015-01-01

    Medical devices (MDs) cover a wide variety of products. They accompany changes in medical practice in step with technology innovations. Innovations in the field of MDs can improve the conditions of use of health technology and/or modify the organisation of care beyond the strict diagnostic or therapeutic benefit for the patients. However, these non purely clinical criteria seem to be only rarely documented or taken into account in the assessment of MDs during reimbursement decisions at national level or for formulary listing by hospitals even though multidimensional models for the assessment of health technologies have been developed that take into account the views of all stakeholders in the healthcare system In this article, after summarising the background concerning the assessment of health technologies in France, a definition of non-clinical criteria for the assessment of MDs is proposed and a decision tree for the assessment of MDs is described. Future lines of approach are proposed as a conclusion. PMID:25747839

  1. Navigating conflicts of interest for the medical device entrepreneur.

    PubMed

    Donovan, Aine; Kaplan, Aaron V

    2012-01-01

    The past fifty years has witnessed dramatic progress in the understanding and treatment of patients suffering from cardiovascular disease leading to symptomatic relief and impressive increases in longevity. These advances have been due in large part to the development, study and implementation of new technology. Within interventional cardiology in particular, these advances have been driven by the availability of new technology in the form of medical devices. Successful device development efforts require close collaboration among basic scientist, clinician-inventors/entrepreneurs, clinician-investigators and corporations. Though the role of the clinician is central to this process, these activities present important conflicts-of-interest (COIs). The purpose of this paper is to 1) characterize these conflicts, 2) provide a context from which to approach their management and 3) recommend management strategies. PMID:23217436

  2. Development of medical electronic devices in the APL space department

    NASA Technical Reports Server (NTRS)

    Newman, A. L.

    1985-01-01

    Several electronic devices for automatically correcting specific defects in a body's physiologic regulation and allowing approximately normal functioning are described. A self-injurious behavior inhibiting system (SIBIS) is fastened to the arm of a person with chronic self-injurious behavior patterns. An electric shock is delivered into the arm whenever the device senses above-threshold acceleration of the head such as occur with head-bangers. Sounding a buzzer tone with the shock eventually allows transference of the aversive stimulus to the buzzer so shocks are no longer necessary. A programmable implantable medication system features a solenoid pump placed beneath the skin and refueled by hypodermic needle. The pump functions are programmable and can deliver insulin, chemotherapy mixes and/or pain killers according to a preset schedule or on patient demand. Finally, an automatic implantible defibrillator has four electrodes attached directly to the heart for sensing electrical impulses or emitting them in response to cardiac fibrillation.

  3. Atmospheric Pressure Plasmas for Decontamination of Complex Medical Devices

    NASA Astrophysics Data System (ADS)

    Weltmann, Klaus-Dieter; Winter, Jörn; Polak, Martin; Ehlbeck, Jörg; von Woedtke, Thomas

    Atmospheric pressure plasma sources produce a multiplicity of different antimicrobial agents and are applicable to even complicated geometries as well as to heat sensitive materials. Thus, atmospheric pressure plasmas have a huge potential for the decontamination of even complex medical devices like central venous catheters and endoscopes. In this paper we present practicable realizations of atmospheric pressure plasma sources, namely plasma jet, dielectric barrier discharge and microwave driven discharge that are able to penetrate fine lumen or are adaptable to difficult geometries. Furthermore, the antimicrobial efficacy of these sources is given for one example setup in each case.

  4. Challenges to validation of a complex nonsterile medical device tray.

    PubMed

    Prince, Daniel; Mastej, Jozef; Hoverman, Isabel; Chatterjee, Raja; Easton, Diana; Behzad, Daniela

    2014-01-01

    Validation by steam sterilization of reusable medical devices requires careful attention to many parameters that directly influence whether or not complete sterilization occurs. Complex implant/instrument tray systems have a variety of configurations and components. Geobacillus stearothermophilus biological indicators (BIs) are used in overkill cycles to to simulate worst case conditions and are intended to provide substantial sterilization assurance. Survival of G. stearothermophilus spores was linked to steam access and size of load in the chamber. By a small and reproducible margin, it was determined that placement of the trays in a rigid container into minimally loaded chambers were more difficult to completely sterilize than maximally loaded chambers. PMID:25046511

  5. [The choice of inhalation device: A medical act].

    PubMed

    Devillier, P; Salvator, H; Roche, N

    2015-06-01

    Inhaled treatments are essential for respiratory diseases management, including COPD and asthma. Optimal control of the disease largely depends on patient's compliance and proper use of these treatments. Different types of ready-to-use inhaler devices are available: metered dose inhaler, dry powder inhaler or soft mist inhaler. Each of these devices presents specific characteristics and constraints that have to be evaluated and taken into account before prescription. In order to optimize adherence and treatment efficacy, the choice of inhaler device should depend on the specific needs, abilities and preferences of each patient and a specific education to treatment should be provided. Inhaled treatments, even containing the same drug, have different technical constraints and are thus not easily interchangeable. Their substitution without prior medical consent and without proper training can lead to errors in taking treatment, treatment failures and increased health care consumption. In France, substitution by the pharmacist is not authorized. While patient education must be carried out in collaboration with all health professionals, it is preferable that the choice of inhaler device remains the responsibility of the physician. PMID:25433462

  6. Varying the Wear Time of the Methylphenidate Transdermal System in Children with Attention-Deficit/Hyperactivity Disorder

    ERIC Educational Resources Information Center

    Wilens, Timothy E.; Boellner, Samuel W.; Lopez, Frank A.; Turnbow, John M.; Wigal, Sharon B.; Childress, Ann C.; Abikoff, Howard B.; Manos, Michael J.

    2008-01-01

    A study investigated the impact of variable wear times of the methylphenidate transdermal system in children with attention-deficit/hyperactivity disorder (ADHD). It was concluded that duration of medication effect was directly related to the wear time of the methylphenidate transdermal system patch.

  7. Transdermal Delivery of Drugs with Microneedles—Potential and Challenges

    PubMed Central

    Ita, Kevin

    2015-01-01

    Transdermal drug delivery offers a number of advantages including improved patient compliance, sustained release, avoidance of gastric irritation, as well as elimination of pre-systemic first-pass effect. However, only few medications can be delivered through the transdermal route in therapeutic amounts. Microneedles can be used to enhance transdermal drug delivery. In this review, different types of microneedles are described and their methods of fabrication highlighted. Microneedles can be fabricated in different forms: hollow, solid, and dissolving. There are also hydrogel-forming microneedles. A special attention is paid to hydrogel-forming microneedles. These are innovative microneedles which do not contain drugs but imbibe interstitial fluid to form continuous conduits between dermal microcirculation and an attached patch-type reservoir. Several microneedles approved by regulatory authorities for clinical use are also examined. The last part of this review discusses concerns and challenges regarding microneedle use. PMID:26131647

  8. Practical pathology perspectives for minimally invasive hyperthermic medical devices

    NASA Astrophysics Data System (ADS)

    Coad, James E.

    2011-03-01

    Currently, hyperthermic-based minimally invasive medical devices are available for the treatment of dysfunctional and neoplastic tissues in a variety of organ systems. These therapies employ a spectrum of modalities for delivering heat energy to the targeted tissue, including radiofrequency/microwave, high intensity focused ultrasound, conductive/convective sources and others. While differences in energy transfer and organ systems exist, hyperthermic treatment sites show a spectrum of changes that intimately correlate with the thermal history generated in the tissue (temperature-time dependence). As a result, these hyperthermic medical technologies can be viewed using a "gradient" approach. First, the thermal applications themselves can be globally categorized along a high-dose ablation to low-dose ablation to lowdose non-ablative rejuvenating slope. Second, the resultant tissue changes can be viewed along a decreasing thermal dose gradient from thermally/heat-fixed tissue necrosis to coagulative tissue necrosis to partial tissue necrosis (transition zone) to subtle non-necrotizing tissue changes. Finally, a gradient of cellular and structural protein denaturation is present, especially within the transition zone and adjacent viable tissue region. A hyperthermic treatment's location along these gradients depends more on the overall thermal history it generates than the amount of energy it deposits into the tissue. The features of these gradients are highlighted to provide a better understanding of hyperthermic device associated tissue changes and their associated healing responses.

  9. Monitoring biofilm attachment on medical devices surfaces using hyperspectral imaging

    NASA Astrophysics Data System (ADS)

    Le, Hanh N. D.; Hitchins, Victoria M.; Ilev, Ilko K.; Kim, Do-Hyun

    2014-02-01

    Microbial biofilm is a colony of single bacteria cells (planktonic) that attached to surfaces, attract other microorganisms to attach and grow, and together they build an extracellular matrix composed of polysaccharides, protein, and DNA. Eventually, some cells will detach and spread to other surface. Biofilm on medical devices can cause severe infection to all age ranges from infant to adult. Therefore, it is important to detect biofilm in a fast and efficient manner. Hyperspectral imaging was utilized for distinguishing wide area of biofilm coverage on various materials and on different textures of stainless steeltest coupons. Not only is the coverage of biofilm important, but also the shear stress of biofilm on the attached surfaces is significant. This study investigates the effects of shear stress on the adhesion of biofilms on common medical device surfaces such as glass, polycarbonate, polytetrafluoroethylene, and stainless steel with different textures. Biofilm was grown using Ps. aeruginosa and growth was monitored after 24 and 48 hours at 37° C. The coupons covered with biofilm were tilted at 45 degrees and 90 degrees for 30 seconds to induce shear stress and Hyperspectral images were taken. We hypothesize that stronger attachment on rough surface would be able to withstand greater shear stress compared to smooth surface.

  10. Audible frequency vibration of puncture-access medical devices.

    PubMed

    Begg, Nikolai D M; Slocum, Alexander H

    2014-03-01

    Ultrasonic vibration has been proven to help scalpels and puncture devices cut and cauterize, but creates a damaged tissue zone that may not be desirable. We have found that audible frequency vibration applied to a needle not only reduces puncture force more than ultrasonic vibration; it does not cause significant immediate tissue damage. Here we thus present a method for decreasing the force required to insert a puncture-access medical device and an analytical model for predicting performance of a hypodermic needle, which correlates well with tests and shows that needle insertion force is lowered not only by decreasing the outer diameter of the needle, but also by driving the device at its free state resonant (amplitude-maximizing) frequency. Finally, an in vivo histology study is conducted and suggests that audible frequency vibration results in the same degree of immediate local tissue damage as simple manually inserted needles, but that it causes significantly less immediate local tissue damage than ultrasonic vibration. PMID:24387905

  11. Medical Device Interoperability to Enable Systems Solutions at the Sharp Edge of Healthcare

    E-print Network

    Rajkumar, Ragunathan "Raj"

    1 Medical Device Interoperability to Enable Systems Solutions at the Sharp Edge of Healthcare highlights C I M I T Julian M. Goldman, MD Harvard Medical School Massachusetts General Hospital Depts. of Anesthesia and Biomedical Engineering Director, CIMIT Program on Interoperability and the Medical Device Plug

  12. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to... Spanish is the predominant language, such labeling is authorized under § 801.15(c)....

  13. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to... Spanish is the predominant language, such labeling is authorized under § 801.15(c)....

  14. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to... Spanish is the predominant language, such labeling is authorized under § 801.15(c)....

  15. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to... Spanish is the predominant language, such labeling is authorized under § 801.15(c)....

  16. 21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to... Spanish is the predominant language, such labeling is authorized under § 801.15(c)....

  17. 77 FR 32644 - Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ... implementing regulations, 21 CFR part 807, require persons who intend to market a new device to submit a... SERVICES Food and Drug Administration Medical Devices; Exemption From Premarket Notification: Wheelchair... provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments of...

  18. 76 FR 71041 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-16

    ... following: (1) Ensure that all devices entering the market are safe and effective, (2) accurately and...; Comment Request; Medical Device Recall Authority AGENCY: Food and Drug Administration, HHS. ACTION: Notice... information collection requirements for medical device recall authority. DATES: Submit either electronic...

  19. 75 FR 49940 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-16

    ... SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: General and Plastic Surgery Devices... November 9, 2010. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2...

  20. 76 FR 62419 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-07

    ... SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: General and Plastic Surgery Devices.... Oral presentations from the public will be scheduled between approximately 1 p.m. and 2...

  1. 75 FR 36102 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-24

    ... SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: General and Plastic Surgery Devices.... Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m....

  2. 76 FR 39882 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-07

    ... SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: General and Plastic Surgery Devices... contact person on or before August 24, 2011. Oral presentations from the public will be scheduled...

  3. 76 FR 14415 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-16

    ... SERVICES Food and Drug Administration General and Plastic Surgery Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: General and Plastic Surgery Devices... April 19, 2011. Oral presentations from the public will be scheduled between approximately 1 p.m. and...

  4. 78 FR 63225 - Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-23

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Ear, Nose and Throat Devices Panel of the Medical Devices... (FDA). The meeting will be open to the public. Name of Committee: Ear, Nose and Throat Devices Panel...

  5. Large Eddy Simulation of FDA’s Idealized Medical Device

    PubMed Central

    Delorme, Yann T.; Anupindi, Kameswararao; Frankel, Steven H.

    2013-01-01

    A hybrid large eddy simulation (LES) and immersed boundary method (IBM) computational approach is used to make quantitative predictions of flow field statistics within the Food and Drug Administration’s (FDA) idealized medical device. An in-house code is used, hereafter (W enoHemo™), that combines high-order finite-difference schemes on structured staggered Cartesian grids with an IBM to facilitate flow over or through complex stationary or rotating geometries and employs a subgrid-scale (SGS) turbulence model that more naturally handles transitional flows [2]. Predictions of velocity and wall shear stress statistics are compared with previously published experimental measurements from Hariharan et al. [6] for the four Reynolds numbers considered. PMID:24187599

  6. An electronic post market surveillance system for medical devices.

    PubMed

    Vlachos, I; Kalivas, D; Panou-Diamandi, O

    2003-06-01

    An important issue in the health care sector is the collection of information about adverse incidents relative to medical devices and the exchange of this information among Health Care Institutions, Manufacturers and Competent Authorities. We present an Electronic Post Market Surveillance System, which solves in an efficient and secure way the above problem and it is compliant to the International Standards. The system consists of the PMS Server Application installed in the manufacturers/suppliers premises and the PMS Client Application installed in the Health Care Institutions. The PMS applications are used for the management of the PMS Reports and Responses with important features such as the user-friendly interfaces, interoperability and different implementations depending on the performance and cost requirements. The messages are in XML format and the security is based on public-private key cryptography. The system was evaluated in a systematic way by a variety of users, who were satisfied by the system functionality and efficiency. PMID:12758134

  7. Evaluation of the medical device approval lag between the United States and the European Union

    E-print Network

    Dhavale, Todd V

    2011-01-01

    The United States is the world leader in development and manufacture of medical devices. Even with this leadership position, there is evidence that the US is often not the first country to have new medical technology ...

  8. 77 FR 15779 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-16

    ...and FDA-2011-M-0917] Medical Devices; Availability of Safety...COBALT October 26, 2011. iliac balloon- expandable stent system...delivery system, RETROFLEX balloon catheter and crimper. P090016...FDA-2011-M-0848.......... BSD Medical Corp..... BSD-2000...

  9. 42 CFR 410.36 - Medical supplies, appliances, and devices: Scope.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 2 2011-10-01 2011-10-01 false Medical supplies, appliances, and devices: Scope. 410.36 Section 410.36 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS Medical and Other Health Services § 410.36 Medical...

  10. Nanobionics: the impact of nanotechnology on implantable medical bionic devices

    NASA Astrophysics Data System (ADS)

    Wallace, G. G.; Higgins, M. J.; Moulton, S. E.; Wang, C.

    2012-07-01

    The nexus of any bionic device can be found at the electrode-cellular interface. Overall efficiency is determined by our ability to transfer electronic information across that interface. The nanostructure imparted to electrodes plays a critical role in controlling the cascade of events that determines the composition and structure of that interface. With commonly used conductors: metals, carbon and organic conducting polymers, a number of approaches that promote control over structure in the nanodomain have emerged in recent years with subsequent studies revealing a critical dependency between nanostructure and cellular behaviour. As we continue to develop our understanding of how to create and characterise electromaterials in the nanodomain, this is expected to have a profound effect on the development of next generation bionic devices. In this review, we focus on advances in fabricating nanostructured electrodes that present new opportunities in the field of medical bionics. We also briefly evaluate the interactions of living cells with the nanostructured electromaterials, in addition to highlighting emerging tools used for nanofabrication and nanocharacterisation of the electrode-cellular interface.

  11. Home Healthcare Medical Devices: Infusion Therapy - Getting the Most Out of Your Pump

    MedlinePLUS

    ... and Consumer Devices Brochure - Home Healthcare Medical Devices: Infusion Therapy - Getting the Most Out of Your Pump ... therapy. What do you do before using your infusion pump? Read your pump's Instructions for Use and ...

  12. Encryption on the air : non-Invasive security for implantable medical devices

    E-print Network

    Al-Hassanieh, Haitham (Haitham Zuhair)

    2011-01-01

    Modern implantable medical devices (IMDs) including pacemakers, cardiac defibrillators and nerve stimulators feature wireless connectivity that enables remote monitoring and post-implantation adjustment. However, recent ...

  13. Medical devices; reprocessed single-use devices; requirement for submission of validation data. Direct final rule.

    PubMed

    2006-09-25

    The Food and Drug Administration (FDA or we) is amending certain classification regulations for reprocessed single-use devices (SUDs) whose exemption from premarket notification (510(k)) requirements have been terminated and other reprocessed SUDs already subject to premarket notification for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a 510(k). Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule. This action codifies actions taken in previous Federal Register notices in accordance with MDUFMA. PMID:17017469

  14. Dosing considerations with transdermal formulations of fentanyl and buprenorphine for the treatment of cancer pain

    PubMed Central

    Skaer, Tracy L

    2014-01-01

    Opioids continue to be first-line pharmacotherapy for patients suffering from cancer pain. Unfortunately, subtherapeutic dosage prescribing of pain medications remains common, and many cancer patients continue to suffer and experience diminished quality of life. A large variety of therapeutic options are available for cancer pain patients. Analgesic pharmacotherapy is based on the patient’s self-report of pain intensity and should be tailored to meet the requirements of each individual. Most, if not all, cancer pain patients will ultimately require modifications in their opioid pharmacotherapy. When changes in a patient’s medication regimen are needed, adequate pain control is best maintained through appropriate dosage conversion, scheduling immediate release medication for withdrawal prevention, and providing as needed dosing for breakthrough pain. Transdermal opioids are noninvasive, cause less constipation and sedation when compared to oral opioids, and may improve patient compliance. A relative potency of 100:1 is recommended when converting the patient from oral morphine to transdermal fentanyl. Based on the limited data available, there is significant interpatient variability with transdermal buprenorphine and equipotency recommendations from oral morphine of 75:1–110:1 have been suggested. Cancer patients may require larger transdermal buprenorphine doses to control their pain and may respond better to a more aggressive 75–100:1 potency ratio. This review outlines the prescribing of transdermal fentanyl and transdermal buprenorphine including how to safely and effectively convert to and use them for those with cancer pain. PMID:25170278

  15. The potential of medical device industry in technological and economical context.

    PubMed

    Maresova, Petra; Penhaker, Marek; Selamat, Ali; Kuca, Kamil

    2015-01-01

    The high quality of public health improves not only healthy life expectancy, but also the productivity of labor. The most important part of the health care sector is the medical technology industry. The aim of this study is to analyze the current situation in the medical device industry in Europe, its potential strengths and weaknesses in the context of topical economic and demographic development. The contribution specifies an analysis of the economic state of the medical device industry in the context of demographic development of European Union's macroeconomic indicators and views of experts in the field of medical device development, concerning the opportunities for entities involved in the medical device market. There is fierce competition on the European market. The innovative activity is stable and well regulated by responsible authorities. Worldwide, the medical device market is expected to grow. PMID:26491337

  16. The potential of medical device industry in technological and economical context

    PubMed Central

    Maresova, Petra; Penhaker, Marek; Selamat, Ali; Kuca, Kamil

    2015-01-01

    The high quality of public health improves not only healthy life expectancy, but also the productivity of labor. The most important part of the health care sector is the medical technology industry. The aim of this study is to analyze the current situation in the medical device industry in Europe, its potential strengths and weaknesses in the context of topical economic and demographic development. The contribution specifies an analysis of the economic state of the medical device industry in the context of demographic development of European Union’s macroeconomic indicators and views of experts in the field of medical device development, concerning the opportunities for entities involved in the medical device market. There is fierce competition on the European market. The innovative activity is stable and well regulated by responsible authorities. Worldwide, the medical device market is expected to grow. PMID:26491337

  17. 75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ...ACTION: Notice of public educational forum...is announcing a public educational forum entitled ``Drugs & Medical Device Supplier Management Forum.'' This 2-day public educational forum, a component of...

  18. Scouting For Approval: Lessons on Medical Device Regulation in an Era of Crowdfunding from Scanadu's "Scout".

    PubMed

    Smith, Colleen

    2015-01-01

    Internet crowdfunding, a new and increasingly popular method of raising capital to develop products and businesses, has recently come into conflict with the Food and Drug Administration's (FDA's) regulation of medical devices. This Article examines the issues that arise when companies pre-sell medical devices via crowdfunding campaigns before gaining FDA approval of the devices. Because Internet crowdfunding has only been in use for a few years, little has been written about it academically, particularly about its interaction with FDA regulations. The rising interest in crowdfunding, coupled with the downturn in investment in the American medical device industry, make this a salient issue that is ripe for FDA review. This Article uses the crowdfunding campaign Scanadu, a medical device company, conducted in 2013 to raise money to develop its in-home diagnostic device, the "Scout," as a starting point for this analysis. Because it is extremely costly to develop a device and obtain FDA approval, medical device companies should be able to utilize crowdfunding to raise the necessary capital. However, because of the possible dangers medical devices pose, FDA needs to review the risks created by allowing companies to crowdfund medical devices and should issue guidance to help companies comply with FDA regulations while still allowing them to take advantage of the benefits of crowdfunding. This guidance should ensure the continued commitment to consumer safety that is at the core of FDA regulation. PMID:26292478

  19. 76 FR 12743 - Medical Device Reporting; Malfunction Reporting Frequency

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ...II devices that are not permanently implantable, life supporting, or life sustaining...class II devices that are permanently implantable, life supporting, or life sustaining...class II devices that are permanently implantable, life supporting, or life...

  20. Medical device design for adolescent adherence and developmental goals: a case study of a cystic fibrosis physiotherapy device

    PubMed Central

    Lang, Alexandra R; Martin, Jennifer L; Sharples, Sarah; Crowe, John A

    2014-01-01

    Purpose This study investigates the psychosocial aspects of adolescent medical device use and the impact on adolescent adherence and goals for the transitional years between child and adulthood. Patients and methods Interviews were carried out with 20 adolescents with cystic fibrosis, investigating adolescent medical device use and experiences in relation to their personal and social lives and development through the adolescent years. The qualitative dataset was thematically examined using a content analysis method. Results The results show that adolescent users of medical technologies want their independence and capabilities to be respected. Adolescent adherence to medical device use was associated with short- and long-term motivations, where older adolescents were able to comprehend the longer-term benefits of use against short-term inconvenience more acutely than younger adolescents. It was suggested that medical devices could provide a tool for communication with families and clinicians and could support adolescents as they take responsibility for managing their condition. Themes of “fitting into teenage life” and “use in the community” were associated with adolescents’ needs to form their own identity and have autonomy. Conclusion This study shows that adolescent needs regarding medical device use are complex. It provides evidence to suggest that devices designed inclusively for adolescents may lead to improved adherence and also facilitate transition through the adolescent years and achievement of adolescent goals. PMID:24669187

  1. Polymeric microdevices for transdermal and subcutaneous drug delivery.

    PubMed

    Ochoa, Manuel; Mousoulis, Charilaos; Ziaie, Babak

    2012-11-01

    Low cost manufacturing of polymeric microdevices for transdermal and subcutaneous drug delivery is slated to have a major impact on next generation devices for administration of biopharmaceuticals and other emerging new formulations. These devices range in complexity from simple microneedle arrays to more complicated systems incorporating micropumps, micro-reservoirs, on-board sensors, and electronic intelligence. In this paper, we review devices currently in the market and those in the earlier stages of research and development. We also present two examples of the research in our laboratory towards using phase change liquids in polymeric structures to create disposable micropumps and the development of an elastomeric reservoir for MEMS-based transdermal drug delivery systems. PMID:23000744

  2. 75 FR 391 - Medical Device Quality System Regulation Educational Forum on Risk Management Through the Product...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-05

    ...DEPARTMENT OF HEALTH AND HUMAN...Medical Device Quality System Regulation...Through the Product Life Cycle; Public...ACTION: Notice of public workshop...FDA), Office of Regulatory Affairs...Medical Device Quality System Regulation...through the Product Life Cycle.''...

  3. [Overview on the market, supervision and standardization of nanomaterial-contained medical devices].

    PubMed

    Shao, Anliang; Xu, Liming

    2015-01-01

    In this paper, industry development and market tendency, supervision and standardization of nanomaterial-contained medical devices are overviewed comprehensively based on a large number of reference data including national and international information. Furthermore, the consideration about standardization of biological evaluation for nanomaterial-contained medical devices is discussed by combined some works performed in our laboratory. PMID:26027296

  4. 76 FR 17657 - Medical Device Epidemiology Network 2011: Second Annual Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-30

    ... SERVICES Food and Drug Administration Medical Device Epidemiology Network 2011: Second Annual Public... Administration (FDA) is announcing a public workshop entitled ``Medical Device Epidemiology Network (MDEpiNet.... We aim to describe and solicit feedback on the establishment of a network that works with FDA...

  5. 77 FR 10537 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... SERVICES Food and Drug Administration Food and Drug Administration/Xavier University Global Medical Device... and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Medical Device Conference.'' This...

  6. 75 FR 15439 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-29

    ... SERVICES Food and Drug Administration Food and Drug Administration/Xavier University Global Medical Device... and Drug Administration (FDA) Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Medical Device Conference.'' This...

  7. Monitoring of biofilm formation on different material surfaces of medical devices using hyperspectral imaging method

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Contamination of the inner surface of indwelling (implanted) medical devices by microbial biofilm is a serious problem. Some microbial bacteria such as Escherichia coli form biofilms that lead to potentially life-threatening infections. Other types of medical devices such as bronchoscopes and duod...

  8. Can Product Specific Assurance Case Templates be Used as Medical Device

    E-print Network

    Wassyng, Alan

    1 Can Product Specific Assurance Case Templates be Used as Medical Device Standards? Alan Wassyng--International standards are a key ingredient in the quality assurance of software intensive medical devices. One problem) introduced a (strong) recommendation that manufacturers submit an Assurance Case in their submission

  9. 77 FR 26769 - Educational Forum on Medical Device Reporting, Complaint Files, and Recalls, Corrections, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-07

    ... SERVICES Food and Drug Administration Educational Forum on Medical Device Reporting, Complaint Files, and... Industry Coalition (FMDIC), is announcing a public workshop entitled ``Educational Forum on Medical Device... are in part to respond to industry inquiries, develop educational materials, sponsor workshops...

  10. 78 FR 12067 - Extreme Weather Effects on Medical Device Safety and Quality

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-21

    ... HUMAN SERVICES Food and Drug Administration Extreme Weather Effects on Medical Device Safety and Quality... Drug Administration (FDA) is studying the potential effects of extreme weather and natural disasters on... extreme weather effects on medical device safety and quality. DATES: Submit either electronic or...

  11. 75 FR 29560 - Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-26

    ... Medical Device Development; Notice of Public Workshop; Request for Comments AGENCY: Food and Drug... Innovation in Medical Device Development.'' The purpose of the workshop is to obtain public input on what are the most important unmet public health needs and what are the barriers to the development of...

  12. 76 FR 16350 - Medical Devices; Ovarian Adnexal Mass Assessment Score Test System; Labeling; Black Box Restrictions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-23

    ... SERVICES Food and Drug Administration 21 CFR Part 866 Medical Devices; Ovarian Adnexal Mass Assessment... results, or to delay in tumor diagnosis due to false negative results. II. Why is FDA proposing to require..., Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority...

  13. Abstract--Medical device software is sometimes initially developed by using a PC simulation environment that executes

    E-print Network

    Vahid, Frank

    Abstract--Medical device software is sometimes initially developed by using a PC simulation the actual medical device to a physical mockup of the physiological system. An alternative is to connect the medical device to a digital mockup of the physiological system, such that the device believes

  14. Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.

    PubMed

    Jalbert, Jessica J; Ritchey, Mary Elizabeth; Mi, Xiaojuan; Chen, Chih-Ying; Hammill, Bradley G; Curtis, Lesley H; Setoguchi, Soko

    2014-11-01

    Medical devices play a vital role in diagnosing, treating, and preventing diseases and are an integral part of the health-care system. Many devices, including implantable medical devices, enter the market through a regulatory pathway that was not designed to assure safety and effectiveness. Several recent studies and high-profile device recalls have demonstrated the need for well-designed, valid postmarketing studies of medical devices. Medical device epidemiology is a relatively new field compared with pharmacoepidemiology, which for decades has been developed to assess the safety and effectiveness of medications. Many methodological considerations in pharmacoepidemiology apply to medical device epidemiology. Fundamental differences in mechanisms of action and use and in how exposure data are captured mean that comparative effectiveness studies of medical devices often necessitate additional and different considerations. In this paper, we discuss some of the most salient issues encountered in conducting comparative effectiveness research on implantable devices. We discuss special methodological considerations regarding the use of data sources, exposure and outcome definitions, timing of exposure, and sources of bias. PMID:25255810

  15. Optimize Use of Space Research and Technology for Medical Devices

    NASA Technical Reports Server (NTRS)

    Minnifield, Nona K.

    2012-01-01

    systems, and cutting-edge component technologies to conduct a wide range of scientific observations and measurements. These technologies are also considered for practical applications that benefit society in remarkable ways. At NASA Goddard, the technology transfer initiative promotes matching technologies from Earth and space science needs to targeted industry sectors. This requires clear knowledge of industry needs and priorities and social demands. The process entails matching mature technologies where there are known innovation challenges and good opportunities for matching technology needs. This requires creative thinking and takes commitment of time and resources. Additionally, we also look at applications for known hot industry or societal needs. Doing so has given us occasion to host discussions with representatives from industry, academia, government organizations, and societal special interest groups about the application of NASA Goddard technologies for devices used in medical monitoring and detection tools. As a result, partnerships have been established. Innovation transpired when new products were enabled because of NASA Goddard research and technology programs.

  16. 75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... HUMAN SERVICES Food and Drug Administration Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public educational forum. SUMMARY: The Food and Drug Administration...

  17. 76 FR 41507 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-14

    ... From the Federal Register Online via the Government Printing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of...

  18. 78 FR 950 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-07

    ...-2012-M-1011, and FDA-2012-M-1013] Medical Devices; Availability of Safety and Effectiveness Summaries.......... Torax Medical, Inc LINX \\TM\\ Reflux March 22, 2012. Management System. P010031/S232, FDA-2012-M-0814.... Trabecular Micro- Bypass Stent and Inserter. P110007, FDA-2012-M-0734....... Abbott Medical Healon July...

  19. 78 FR 950 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-07

    ...and FDA-2012-M-1013] Medical Devices; Availability of Safety...FDA-2012-M-0893....... Torax Medical, Inc LINX \\TM\\ Reflux March...FDA-2012-M-0734....... Abbott Medical Healon[supreg] July 2...Elite July 31, 2012. Vascular Balloon- Expandable Stent...

  20. Fentanyl Transdermal Patch

    MedlinePLUS

    Fentanyl patches are used to relieve severe pain in people who are expected to need pain medication ... and who cannot be treated with other medications. Fentanyl is in a class of medications called opiate ( ...

  1. 78 FR 46347 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-31

    ... effectiveness of a device), packing, storage, and installation of a device conform to CGMP, as described in such..., packing, labeling, storage, installation, and servicing of all finished medical devices intended for human... shall establish/ maintain procedures to control labeling storage/application; and...

  2. 75 FR 36092 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-24

    ... effectiveness of a device), packing, storage, and installation of a device conform to CGMP, as described in such..., packing, labeling, storage, installation, and servicing of all finished medical devices intended for human... shall establish/maintain procedures to control labeling storage/application; and examination/...

  3. MedMon: securing medical devices through wireless monitoring and anomaly detection.

    PubMed

    Zhang, Meng; Raghunathan, Anand; Jha, Niraj K

    2013-12-01

    Rapid advances in personal healthcare systems based on implantable and wearable medical devices promise to greatly improve the quality of diagnosis and treatment for a range of medical conditions. However, the increasing programmability and wireless connectivity of medical devices also open up opportunities for malicious attackers. Unfortunately, implantable/wearable medical devices come with extreme size and power constraints, and unique usage models, making it infeasible to simply borrow conventional security solutions such as cryptography. We propose a general framework for securing medical devices based on wireless channel monitoring and anomaly detection. Our proposal is based on a medical security monitor (MedMon) that snoops on all the radio-frequency wireless communications to/from medical devices and uses multi-layered anomaly detection to identify potentially malicious transactions. Upon detection of a malicious transaction, MedMon takes appropriate response actions, which could range from passive (notifying the user) to active (jamming the packets so that they do not reach the medical device). A key benefit of MedMon is that it is applicable to existing medical devices that are in use by patients, with no hardware or software modifications to them. Consequently, it also leads to zero power overheads on these devices. We demonstrate the feasibility of our proposal by developing a prototype implementation for an insulin delivery system using off-the-shelf components (USRP software-defined radio). We evaluate its effectiveness under several attack scenarios. Our results show that MedMon can detect virtually all naive attacks and a large fraction of more sophisticated attacks, suggesting that it is an effective approach to enhancing the security of medical devices. PMID:24473551

  4. Microneedle-mediated transdermal bacteriophage delivery

    PubMed Central

    Ryan, Elizabeth; Garland, Martin J.; Singh, Thakur Raghu Raj; Bambury, Eoin; O’Dea, John; Migalska, Katarzyna; Gorman, Sean P.; McCarthy, Helen O.; Gilmore, Brendan F.; Donnelly, Ryan F.

    2012-01-01

    Interest in bacteriophages as therapeutic agents has recently been reawakened. Parenteral delivery is the most routinely-employed method of administration. However, injection of phages has numerous disadvantages, such as the requirement of a health professional for administration and the possibility of cross-contamination. Transdermal delivery offers one potential means of overcoming many of these problems. The present study utilized a novel poly (carbonate) (PC) hollow microneedle (MN) device for the transdermal delivery of Escherichia coli-specific T4 bacteriophages both in vitro and in vivo. MN successfully achieved bacteriophage delivery in vitro across dermatomed and full thickness skin. A concentration of 2.67 × 106 PFU/ml (plaque forming units per ml) was detected in the receiver compartment when delivered across dermatomed skin and 4.0 × 103 PFU/ml was detected in the receiver compartment when delivered across full thickness skin. An in vivo study resulted in 4.13 × 103 PFU/ml being detected in blood 30 min following initial MN-mediated phage administration. Clearance occurred rapidly, with phages being completely cleared from the systemic circulation within 24 h, which was expected in the absence of infection. We have shown here that MN-mediated delivery allows successful systemic phage absorption. Accordingly, bacteriophage-based therapeutics may now have an alternative route for systemic delivery. Once fully-investigated, this could lead to more widespread investigation of these interesting therapeutic viruses. PMID:22750416

  5. Simulating acceleration from stereophotogrammetry for medical device design.

    PubMed

    Tresadern, Philip A; Thies, Sibylle B; Kenney, Laurence P J; Howard, David; Smith, Christine; Rigby, Julie; Goulermas, John Y

    2009-06-01

    When designing a medical device based on lightweight accelerometers, the designer is faced with a number of questions in order to maximize performance while minimizing cost and complexity: Where should the inertial unit be located? How many units are required? How is performance affected if the unit is not correctly located during donning? One way to answer these questions is to use position data from a single trial, captured with a nonportable measurement system (e.g., stereophotogrammetry) to simulate measurements from multiple accelerometers at different locations on the body. In this paper, we undertake a thorough investigation into the applicability of these simulated acceleration signals via a series of interdependent experiments of increasing generality. We measured the dynamics of a reference coordinate frame using stereophotogrammetry over a number of trials. These dynamics were then used to simulate several "virtual" accelerometers at different points on the body segment. We then compared the simulated signals with those directly measured to evaluate the error under a number of conditions. Finally, we demonstrated an example of how simulated signals can be employed in a system design application. In the best case, we may expect an error of 0.028 m/s2 between a derived virtual signal and that directly measured by an accelerometer. In practice, however, using centripetal and tangential acceleration terms (that are poorly estimated) results in an error that is an order of magnitude greater than the baseline. Furthermore, nonrigidity of the limb can increase error dramatically, although the effects can be reduced considerably via careful modeling. We conclude that using simulated signals has definite benefits when an appropriate model of the body segment is applied. PMID:19449956

  6. [Medical devices. Regulatory framework and contribution of the German Federal Institute for Drugs and Medical Devices (BfArM) to the safe application].

    PubMed

    Lauer, Wolfgang; Stößlein, E; Brinker, A; Broich, K

    2014-12-01

    Medical devices are of great importance for the prevention, diagnosis and treatment of many diseases. With their broad range and interdisciplinarity, they represent both a very dynamic field of innovation and a significant sector of the economy. The European and thus the German Medical Devices Act aim in this context to make new medical devices for patients and users rapidly available while ensuring safety and performance at the same time. The main responsibility for this lies with the manufacturer. In addition, others are involved in a complex collaboration in the conformity assessment and also later in the marketing phase for the early identification, assessment and minimization of potential risks. This paper presents the legal framework for medical devices and the related roles and responsibilities of various stakeholders, especially the two federal agencies the German Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute (PEI). From the perspective of the BfArM the procedure and criteria for risk assessment of incident reports are explained and the experiences and wishes from regulatory practice are described. The active engagement of the BfArM to contribute knowledge from the incident report assessment within the relevant standards organisations and the medical profession is described using examples of medical devices from the field of out-of-hospital ventilation. The paper concludes with a look at future challenges, e.g. in combination products, IT networks and automatization, as well as on current developments to improve risk identification and assessment in a European context. PMID:25370170

  7. The transdermal delivery of fentanyl.

    PubMed

    Lane, Majella E

    2013-08-01

    The fentanyl patch is one of the great commercial successes in transdermal drug delivery. The suitability of this molecule for delivery through skin had been identified in the 1970s, and subsequently, a number of transdermal formulations became available on the market. This article reviews the development of fentanyl patch technology with particular emphasis on the pharmacokinetics and disposition of the drug when delivered through the skin. The various patch designs are considered as well as the bioequivalence of the different designs. The influence of heat on fentanyl permeation is highlighted. Post-mortem redistribution of fentanyl is discussed in light of the reported discrepancies in serum levels reported in patients after death compared with therapeutic levels in living subjects. Finally, alternatives to patch technology are considered, and recent novel transdermal formulations are highlighted. PMID:23419814

  8. Transdermal innovations in diabetes management.

    PubMed

    Rao, Rekha; Mahant, Sheefali; Chhabra, Lovely; Nanda, Sanju

    2014-01-01

    Diabetes mellitus, an endocrine disorder affecting glucose metabolism, has been crippling mankind for the past two centuries. Despite the advancements in the understanding pertaining to its pathogenesis and treatment, the currently available therapeutic options are far from satisfactory. The growing diabetic population increases the gravity of the situation. The shortcomings of the conventional drug delivery systems necessitate the need to delve into other routes. On account of its merits over other routes, the transdermal approach has drawn the interest of the researchers around the world. The transdermal drug delivery systems are aimed to achieve therapeutic concentrations of the drug through skin. These systems are designed so that the drug can be delivered at a pre-determined and controlled rate. This makes it particularly conducive to treat chronic disorders like diabetes. Correspondingly, the adverse effects and inconvenience concomitant with oral and parentral route are circumvented. This article attempts to outline the development of transdermal drug delivery systems to optimize diabetes pharmacotherapy. It not only covers the transdermal approaches adopted to fine-tune insulin delivery, but also, discusses various transdermal drug delivery systems fabricated to improve the therapeutic performance of oral hypoglycaemic agents. Such formulations include the advanced drug delivery systems, namely, transferosomal gels, microemulsions, self-dissolving micropiles, nanoparticles, insulin pumps, biphasic lipid systems, calcium carbonate nanoparticles, lecithin nanoparticles; physical techniques such as iontophoresis and microneedles and, drugs formulated as transdermal patches. In addition to this, the authors have also shed light on the future prospects and patented and commercial formulations of antidiabetic agents. PMID:25418713

  9. 78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ... HUMAN SERVICES Food and Drug Administration Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug... availability of the draft guidance entitled ``Medical Device Development Tools.'' This document...

  10. 76 FR 6623 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-07

    ...Docket No. FDA-2011-N-0066] Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of...to the public. Name of Committee: Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee. General...

  11. 78 FR 951 - Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-07

    ...Medical Device Labeling in a Standard Content and Format Public Workshop; Request for...encourage public comments regarding standard content and format for medical device labeling...during the general session. Standard content and format of full labeling and a...

  12. Medical devices for restless legs syndrome – clinical utility of the Relaxis pad

    PubMed Central

    Mitchell, Ulrike H

    2015-01-01

    Restless Legs Syndrome or Willis–Ekbom Disease, a neurosensory disorder, can be treated with pharmaceuticals or conservatively. This review focuses on conservative treatments, more specifically on treatments with medical devices. Two modes of action, enhancement of circulation and counter stimulation, are introduced. Medical devices that use enhancement of circulation as their mechanism of action are whole body vibration, pneumatic compression, and near-infrared light. Medical devices that use counter stimulation include transcutaneous electrical nerve stimulation and the vibration Relaxis pad. The clinical utility of the Relaxis pad and its place in therapy is proposed. PMID:26664128

  13. 21 CFR 801.1 - Medical devices; name and place of business of manufacturer, packer or distributor.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices; name and place of business of manufacturer, packer or distributor. 801.1 Section 801.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.1 Medical devices; name and place...

  14. 75 FR 20854 - Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-21

    ...FDA-2010-N-0202] Medical Device Use in the Home Environment: Implications for the Safe and Effective...entitled Medical Device Use in the Home Environment: Implications for the Safe and Effective...medical device technology in the home environment. FDA seeks input and comments on...

  15. U.S. industry leads the world in medical device innovation and production. From imaging instrumentation, monitoring

    E-print Network

    Fainman, Yeshaiahu

    U.S. industry leads the world in medical device innovation and production. From imaging generation of medical devices will build on recent advances in bioengineering, biomaterials, genomics, computing and telecommunications. The UC San Diego Master of Advanced Study in Medical Device Engineering

  16. 77 FR 16036 - Guidance for Industry, Third Parties and Food and Drug Administration Staff; Medical Device ISO...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-19

    ...and Food and Drug Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit...availability of the guidance entitled ``Medical Device ISO 13485:2003 Voluntary Audit...of the guidance document entitled ``Medical Device ISO 13485:2003 Voluntary...

  17. 76 FR 24494 - Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-02

    ... Medical Devices in Health Care Settings: Validation Methods and Labeling; Availability AGENCY: Food and...: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.'' The... Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care...

  18. 21 CFR 801.1 - Medical devices; name and place of business of manufacturer, packer or distributor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices; name and place of business of..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.1 Medical devices; name and place of business of manufacturer, packer or distributor. (a)...

  19. 21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... requirements for medical devices held by the Strategic National Stockpile. 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... requirements for medical devices held by the Strategic National Stockpile. (a) The appropriate FDA...

  20. 21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... requirements for medical devices held by the Strategic National Stockpile. 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... requirements for medical devices held by the Strategic National Stockpile. (a) The appropriate FDA...

  1. 21 CFR 801.1 - Medical devices; name and place of business of manufacturer, packer or distributor.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices; name and place of business of..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.1 Medical devices; name and place of business of manufacturer, packer or distributor. (a)...

  2. 21 CFR 801.1 - Medical devices; name and place of business of manufacturer, packer or distributor.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices; name and place of business of manufacturer, packer or distributor. 801.1 Section 801.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING General Labeling Provisions § 801.1 Medical devices; name and place...

  3. 21 CFR 801.128 - Exceptions or alternatives to labeling requirements for medical devices held by the Strategic...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... requirements for medical devices held by the Strategic National Stockpile. 801.128 Section 801.128 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES... requirements for medical devices held by the Strategic National Stockpile. (a) The appropriate FDA...

  4. 78 FR 951 - Accessible Medical Device Labeling in a Standard Content and Format Public Workshop; Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-07

    ... HUMAN SERVICES Food and Drug Administration Accessible Medical Device Labeling in a Standard Content and... content and format for medical device labeling and the use of a repository containing medical device... session. Standard content and format of full labeling and a shortened version of labeling will...

  5. AC 2012-3822: GENERATING INTEREST IN TECHNOLOGY AND MED-ICAL DEVICES THROUGH AN INTERACTIVE EDUCATIONAL GAME

    E-print Network

    Wu, Mingshen

    EDUCATIONAL GAME Mr. Devin R. Berg, Medical Devices Center, University of Minnesota - Twin Cities Devin R in Technology and Medical Devices Through an Interactive Educational Game Introduction The issue of motivating and educate them in the field of medical devices, a modified, life-sized version of the game Operation

  6. A proposed framework to improve the safety of medical devices in a Canadian hospital context

    PubMed Central

    Polisena, Julie; Jutai, Jeffrey; Chreyh, Rana

    2014-01-01

    Purpose Medical devices are used to monitor, replace, or modify anatomy or physiological processes. They are important health care innovations that enable effective treatment using less invasive techniques, and they improve health care delivery and patient outcomes. Devices can also introduce risk of harm to patients. Our objective was to propose a surveillance system framework to improve the safety associated with the use of medical devices in a hospital. Materials and methods The proposed medical device surveillance system incorporates multiple components to accurately document and assess the appropriate actions to reduce the risk of incidents, adverse events, and patient harm. The assumptions on which the framework is based are highlighted. The surveillance system was designed from the perspective of a tertiary teaching hospital that includes dedicated hospital staff whose mandate is to provide safe patient care to inpatients and outpatients and biomedical engineering services. Results The main components of the surveillance system would include an adverse medical device events database, a medical device/equipment library, education and training, and an open communication and feedback strategy. Close linkages among these components and with external medical device/equipment networks to the hospital must be established and maintained. A feedback mechanism on medical device-related incidents, as well as implementation and evaluation strategies for the surveillance system are described to ensure a seamless transition and a high satisfactory level among the hospital staff. The direct cost items of the proposed surveillance system for consideration, and its potential benefits are outlined. Conclusion The effectiveness of the proposed medical device surveillance system framework can be measured after it has been implemented in a Canadian hospital facility. PMID:24876796

  7. 77 FR 66847 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-07

    ...FDA-2012-N-0001] Circulatory System Devices Panel of the...Name of Committee: Circulatory System Devices Panel of the...III devices. These systems typically consist of...provide noninvasive circulatory support by...

  8. 77 FR 8117 - Medical Devices; Cardiovascular Devices; Classification of the Endovascular Suturing System

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-14

    ...artery. The system is comprised of the implant device and an endovascular delivery device used to implant the endovascular suture. FDA has identified...artery. The system is comprised of the implant device and an endovascular delivery...

  9. 78 FR 13347 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-27

    ...classification for diagnostic devices known as methotrexate enzyme immunoassays. Methotrexate enzyme immunoassays are considered pre- Amendment devices...Device Amendments became effective. Methotrexate enzyme immunoassays are currently regulated under...

  10. 78 FR 19717 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-02

    ...classification for diagnostic devices known as methotrexate enzyme immunoassays. Methotrexate enzyme immunoassays are considered pre-Amendment devices...Device Amendments became effective. Methotrexate enzyme immunoassays are currently regulated under...

  11. 77 FR 18829 - Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... AMPLATZER ASO Device & Gore HELEX ASD Occluder as transcatheter Atrial Septal Defect (ASD) occluders used... first device introduced to the US market in 2001 followed by the Gore HELEX device in 2006. With...

  12. A review of the economic tools for assessing new medical devices.

    PubMed

    Craig, Joyce A; Carr, Louise; Hutton, John; Glanville, Julie; Iglesias, Cynthia P; Sims, Andrew J

    2015-02-01

    Whereas the economic evaluation of pharmaceuticals is an established practice within international health technology assessment (HTA) and is often produced with the support of comprehensive methodological guidance, the equivalent procedure for medical devices is less developed. Medical devices, including diagnostic products, are a rapidly growing market in healthcare, with over 10,000 medical technology patent applications filed in Europe in 2012-nearly double the number filed for pharmaceuticals. This increase in the market place, in combination with the limited, or constricting, budgets that healthcare decision makers face, has led to a greater level of examination with respect to the economic evaluation of medical devices. However, methodological questions that arise due to the unique characteristics of medical devices have yet to be addressed fully. This review of journal publications and HTA guidance identified these characteristics and the challenges they may subsequently pose from an economic evaluation perspective. These unique features of devices can be grouped into four categories: (1) data quality issues; (2) learning curve; (3) measuring long-term outcomes from diagnostic devices; and (4) wider impact from organisational change. We review the current evaluation toolbox available to researchers and explore potential future approaches to improve the economic evaluation of medical devices. PMID:25139635

  13. Implantable Medical Devices with Electric Current Retrieval Assist

    Cancer.gov

    Implantable devices, such as filters and stents, typically include structures that anchor to surrounding tissue. To prevent blood clots from reaching the heart, an IVC filter may be implanted into the patient. While generally effective at preventing movement post-implantation, traditional anchors present challenges when attempting to remove the device from the subject. In particular, the tissue to which the device is anchored may grow around the anchors making removal difficult.

  14. Recent advances in medical device triage technologies for chemical, biological, radiological, and nuclear events.

    PubMed

    Lansdowne, Krystal; Scully, Christopher G; Galeotti, Loriano; Schwartz, Suzanne; Marcozzi, David; Strauss, David G

    2015-06-01

    In 2010, the US Food and Drug Administration (Silver Spring, Maryland USA) created the Medical Countermeasures Initiative with the mission of development and promoting medical countermeasures that would be needed to protect the nation from identified, high-priority chemical, biological, radiological, or nuclear (CBRN) threats and emerging infectious diseases. The aim of this review was to promote regulatory science research of medical devices and to analyze how the devices can be employed in different CBRN scenarios. Triage in CBRN scenarios presents unique challenges for first responders because the effects of CBRN agents and the clinical presentations of casualties at each triage stage can vary. The uniqueness of a CBRN event can render standard patient monitoring medical device and conventional triage algorithms ineffective. Despite the challenges, there have been recent advances in CBRN triage technology that include: novel technologies; mobile medical applications ("medical apps") for CBRN disasters; electronic triage tags, such as eTriage; diagnostic field devices, such as the Joint Biological Agent Identification System; and decision support systems, such as the Chemical Hazards Emergency Medical Management Intelligent Syndromes Tool (CHEMM-IST). Further research and medical device validation can help to advance prehospital triage technology for CBRN events. PMID:25868677

  15. 31 CFR 561.327 - Food, medicine, and medical devices.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., 15 CFR part 774, supplement no. 1 (excluding items classified as EAR 99). (c) The term medical... Administration Regulations, 15 CFR part 774, supplement no. 1 (excluding items classified as EAR 99). ... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false Food, medicine, and medical...

  16. 78 FR 15957 - Food and Drug Administration/Xavier University Global Medical Device Conference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ...Xavier University Global Medical Device...is intended for companies of all sizes and...Future Vision and Strategy Keynote Address...New Regulations, Company Strategy, and Open Discussion...Mark Hot Topics Global Product...

  17. 76 FR 74789 - Scientific Information Request on Pressure Ulcer Treatment Medical Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-01

    ...Scientific Information Request on Pressure Ulcer Treatment Medical Devices AGENCY...HHS. ACTION: Request for Scientific Information...public information requests, including via the...on pressure ulcer treatment strategies,...

  18. 76 FR 71982 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-21

    ... Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices'' that published in the Federal Register of August 8, 2011 (76 FR 48169). In the notice, FDA requested public comments... SERVICES Food and Drug Administration Advancing Regulatory Science for Highly Multiplexed...

  19. 78 FR 56719 - Challenging Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

    ... Medical Devices in the Treatment of Metabolic Diseases: How to Estimate and Reward True Patient-Centric... Estimate and Reward True Patient-Centric Value in Innovation.'' FDA is cosponsoring the workshop with...

  20. 75 FR 51829 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-23

    ... SERVICES Food and Drug Administration Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop; request for comments. SUMMARY: The Food and Drug Administration (FDA) is announcing...

  1. Systems Theoretic Accident Model and Process application : quality control in medical device manufacturing

    E-print Network

    Li, Tieyu

    2013-01-01

    The goal of medical device industry is to provide patients and healthcare professionals effective, reliable, safe and affordable products. However, due to the dynamic and competitive operation and business environment, ...

  2. 78 FR 58316 - Complex Issues in Developing Medical Devices for Pediatric Patients Affected by Rare Diseases...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-23

    ...DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1073] Complex Issues in Developing Medical Devices for Pediatric Patients Affected by Rare Diseases; Public Workshop; Request...

  3. Model for a web based communication system between clinical engineers and medical device companies 

    E-print Network

    Misri, Sandeep

    1999-01-01

    manufacturers. Due to huge numbers of both, an elective means of a 'many to many' interaction between the two is presently not available. This project proposes a model of a communication system between clinical engineers and medical device manufacturers based...

  4. The square peg and the round hole: Murphy's Law and medical device connections.

    PubMed

    Baretich, Matthew F

    2004-01-01

    Engineers have long been aware of Murphy's Law: If anything can go wrong, it will. When applied to medical device design, Murphy's Law indicates that if there is a way that a medical device can be set up incorrectly then someday, somewhere it will be set up incorrectly. In the clinical environment the result may be patient injury or death. Despite this received wisdom, clinical engineers continue to encounter examples of medical device design that invite users to do the wrong thing, with potentially harmful results. This paper focuses on electrical and other connectors incorporated into medical device designs. Examples of potential and actual misconnections, from the earliest days of clinical engineering to the present, are presented and discussed. PMID:17271042

  5. 75 FR 51829 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-23

    ...provide the potential for nanomaterials to be used in a variety of medical device applications. However, some of these nanomaterial properties may also present safety concerns that are not found in their larger counterparts. The use of nanotechnology...

  6. Inventory management strategy for the supply chain of a medical device company

    E-print Network

    Tjhin, Poi Chung

    2012-01-01

    In the medical device industry, many companies rely on a high inventory strategy in order to meet their customers' urgent requirements, sometimes leading to excessive inventory. This problem is compounded when it involves ...

  7. They Can Hear Your Heartbeats: Non-Invasive Security for Implantable Medical Devices

    E-print Network

    Gollakota, Shyamnath

    Wireless communication has become an intrinsic part of modern implantable medical devices (IMDs). Recent work, however, has demonstrated that wireless connectivity can be exploited to compromise the confidentiality of IMDs' ...

  8. 75 FR 6401 - Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-09

    ...No. FDA-2009-M-0513] Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries...for Biologics Evaluation and Research (CBER). This list is intended...for Biologics Evaluation and Research (HFM-17), Food and...

  9. 75 FR 38532 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-02

    ...- 2010-M-0135, FDA-2010-M-0158] Medical Devices; Availability of Safety and Effectiveness Summaries for... Register of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and...

  10. Mergers & acquisitions in the medical device industry : an exploration of factors influencing valuation

    E-print Network

    Robins, Jason S

    2008-01-01

    Valuing medical device companies and technologies is a complex process. Several different approaches and models are often used in combination to determine a transaction valuation. This research uses the Enterprise Value ...

  11. Actuation of shape memory polymer using magnetic fields for applications in medical devices

    E-print Network

    Buckley, Patrick Regan, 1981-

    2004-01-01

    A novel approach to the heating and actuation of shape memory polymer using dispersed Curie temperature thermo-regulated particles is proposed. Such a material has potential applications in medical devices which are delivered ...

  12. Developing an Asia-Pacific manufacturing footprint strategy in the medical device industry

    E-print Network

    Dev, Nishanth K. (Nishanth Krishna)

    2013-01-01

    As medical device manufacturers operating in the Asia-Pacific region are planning for increased demand in the near future, they must evaluate their manufacturing footprint strategies to determine if they are getting the ...

  13. 76 FR 29153 - Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-20

    ...2006N-0109] Medical Devices; Reclassification of the Topical Oxygen Chamber for Extremities; Correction AGENCY: Food and Drug...The document announced that FDA is reclassifying the topical oxygen chamber for extremities (TOCE) from class III to class...

  14. Development and Implementation of a Medical Device Course.

    ERIC Educational Resources Information Center

    Mendel, Philip A.

    1982-01-01

    A course for fifth-year baccalaureate students provides a structured introduction to many of the devices with which pharmacists are involved (contraceptives, convalescent aids, surgical appliances, etc.), and includes assigned readings, lectures, and hands-on experience with industry representatives. Lists of the lecture material, devices, reading…

  15. Transdermal Nicotine for Smoking Cessation.

    ERIC Educational Resources Information Center

    Hughes, John R.; Glaser, Mitchell

    1993-01-01

    Discusses the use of transdermal nicotine (TN) in smoking cessation and its value as an effective procedure. The article reveals that, compared to a placebo, TN has double the quit rate percentages, and less than 5% of smokers quit TN due to side effects. (GLR)

  16. 26 CFR 48.4191-2 - Taxable medical device.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...Example 10. X manufactures portable oxygen concentrators. X sells the portable oxygen concentrators to distributors Y and Z, which, in turn, sell the portable oxygen concentrators to medical institutions and...

  17. Modular reservoir concept for MEMS-based transdermal drug delivery systems

    NASA Astrophysics Data System (ADS)

    Cantwell, Cara T.; Wei, Pinghung; Ziaie, Babak; Rao, Masaru P.

    2014-11-01

    While MEMS-based transdermal drug delivery device development efforts have typically focused on tightly-integrated solutions, we propose an alternate conception based upon a novel, modular drug reservoir approach. By decoupling the drug storage functionality from the rest of the delivery system, this approach seeks to minimize cold chain storage volume, enhance compatibility with conventional pharmaceutical practices, and allow independent optimization of reservoir device design, materials, and fabrication. Herein, we report the design, fabrication, and preliminary characterization of modular reservoirs that demonstrate the virtue of this approach within the application context of transdermal insulin administration for diabetes management.

  18. Rate-controlling biopolymer membranes as transdermal delivery systems for nifedipine: development and in vitro evaluations.

    PubMed

    Thacharodi, D; Rao, K P

    1996-07-01

    Membrane permeation-controlled transdermal delivery devices for the controlled delivery of nifedipine were developed using collagen (which was extracted from calf fetus skin) and chitosan membranes as rate-controlling membrane. To increase the stability of nifedipine in the systems, alginate gel was used as drug reservoir. Transdermal devices were fabricated by adhesive sealing techniques. In vitro drug release studies were carried out using modified Franz diffusion cells. Drug release was found to depend on the type of membrane used to control the drug delivery, suggesting that drug delivery is efficiently controlled by the rate-controlling membranes. PMID:8805978

  19. 75 FR 8375 - Device Improvements to Reduce Unnecessary Radiation Exposure From Medical Imaging; Public Meeting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-24

    ... radiation presents both benefits and risks. Medical imaging has led to improvements in the diagnosis and... Medical Imaging; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION... public meeting entitled: ``Device Improvements to Reduce Unnecessary Radiation Exposure From...

  20. A transcutaneous energy and information transfer system for implanted medical devices.

    PubMed

    Mussivand, T; Hum, A; Diguer, M; Holmes, K S; Vecchio, G; Masters, R G; Hendry, P J; Keon, W J

    1995-01-01

    During the last four decades there has been a rapid increase in the development and usage of medical devices. Currently, there are more than 500,000 devices on the market and 25,000 new devices enter the market each year. Many medical devices are now designed to be implantable (pacemakers, defibrillators, circulatory assist devices, artificial hearts, cochlear implants, neuromuscular stimulators, biosensors, etc.). Almost all of the active devices (those that perform work) and many of the passive devices (those that do not perform work) require a source of power. In addition, these devices need to be monitored and controlled, which can be accomplished by utilizing remote communication methods. A transcutaneous energy transfer system combined with a remote communications system has been developed and evaluated in vitro and in vivo (bovine, porcine, and human cadaver experiments). The energy transfer system can deliver up to 60 W with power transfer efficiencies between 60 and 83%. An automatically tuned, resonant frequency tracking method is used to obtain optimum power transfer over a range of operating conditions. The remote communications system can transfer digital data bidirectionally through intact skin at rates up to 9600 baud. The system transmits information by frequency modulating an 890 nm infrared carrier signal. The system has demonstrated satisfactory performance during multicenter evaluation with ventricular assist and total artificial heart devices. Design improvements have been identified, which will be implemented to produce an optimized system for energy transfer to and remote communications with various implantable medical devices. PMID:8573800