Sample records for device exemption study

  1. 76 FR 70152 - Pilot Program for Early Feasibility Study Investigational Device Exemption Applications

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ...] Pilot Program for Early Feasibility Study Investigational Device Exemption Applications AGENCY: Food and... feasibility study investigational device exemption (IDE) applications. The pilot program will conform to the... Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Under the pilot...

  2. 77 FR 13343 - Pilot Program for Early Feasibility Study Investigational Device Exemption Applications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-06

    ...] Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Termination of... acceptance of nominations for the Early Feasibility Study Investigational Device Exemption (IDE) Applications... technologies to participate in a pilot program for early feasibility study IDE applications. FDA is also...

  3. 78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ...] Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY... Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Through the...

  4. Medical devices; exemptions from premarket notification; class II devices--FDA, Final rule.

    PubMed

    1998-11-03

    The Food and Drug Administration (FDA) is codifying the exemption from premarket notification of all 62 class II (special controls) devices listed as exempt in a January 21, 1998, Federal Register notice, subject to the limitations on exemptions. FDA has determined that for these exempted devices, manufacturers' submissions of premarket notifications are unnecessary to provide a reasonable assurance of safety and effectiveness. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking implements new authorities delegated to FDA under the Food and Drug Administration Modernization Act (FDAMA).

  5. 21 CFR 801.110 - Retail exemption for prescription devices.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Retail exemption for prescription devices. 801.110 Section 801.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.110 Retail exemption...

  6. 21 CFR 801.110 - Retail exemption for prescription devices.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Retail exemption for prescription devices. 801.110 Section 801.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.110 Retail exemption...

  7. 21 CFR 801.110 - Retail exemption for prescription devices.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Retail exemption for prescription devices. 801.110 Section 801.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.110 Retail exemption...

  8. 21 CFR 801.110 - Retail exemption for prescription devices.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Retail exemption for prescription devices. 801.110 Section 801.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.110 Retail exemption...

  9. 21 CFR 801.110 - Retail exemption for prescription devices.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Retail exemption for prescription devices. 801.110 Section 801.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.110 Retail exemption...

  10. 78 FR 23941 - Pilot Program for Early Feasibility Study Investigational Device Exemption Applications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-23

    ...] Pilot Program for Early Feasibility Study Investigational Device Exemption Applications; Extending the... 13343), FDA terminated the acceptance of applications into the program and extended the pilot program for the nine accepted sponsors until May 8, 2013. The pilot program will be further extended for the...

  11. 77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ...] Medical Devices; Exemption From Premarket Notification: Powered Patient Transport AGENCY: Food and Drug... transport devices commonly known as stairlifts. These devices are used to assist transfers of a mobility... behalf of Bruno Independent Living Aids, Inc., for powered patient transport devices (commonly known as...

  12. 40 CFR 63.2251 - What are the requirements for the routine control device maintenance exemption?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... the routine control device maintenance exemption? (a) You may request a routine control device..., explain why the maintenance cannot be accomplished during process shutdowns, describe how you plan to make... device is used to control a green rotary dryer, tube dryer, rotary strand dryer, or pressurized refiner...

  13. Medical devices; exemption from premarket notification; Class II devices; optical impression systems for computer assisted design and manufacturing. Final rule.

    PubMed

    2003-04-22

    The Food and Drug Administration (FDA) is publishing an order granting a petition requesting exemption from the premarket notification requirements for data acquisition units for ceramic dental restoration systems. This rule exempts from premarket notification data acquisition units for ceramic dental restoration systems and establishes a guidance document as a special control for this device. FDA is publishing this order in accordance with the Food and Drug Administration Modernization Act of 1997 (FDAMA).

  14. 76 FR 69321 - Petition to Modify an Exemption of a Previously Approved Antitheft Device; Porsche

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-08

    ... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration Petition to Modify an Exemption of a Previously Approved Antitheft Device; Porsche AGENCY: National Highway Traffic Safety... previously approved antitheft device. SUMMARY: On May 25, 1989, the National Highway Traffic Safety...

  15. 21 CFR 807.65 - Exemptions for device establishments.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

  16. 21 CFR 807.65 - Exemptions for device establishments.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

  17. 21 CFR 807.65 - Exemptions for device establishments.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

  18. 21 CFR 807.65 - Exemptions for device establishments.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

  19. 21 CFR 807.65 - Exemptions for device establishments.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., who manufacture or otherwise alter devices solely for use in their practice. (e) Pharmacies, surgical.... This exemption also applies to a pharmacy or other similar retail establishment that purchases a device... bandage or crutch, indicating “distributed by” or “manufactured for” followed by the name of the pharmacy...

  20. 40 CFR 157.24 - Exemptions.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Exemptions. 157.24 Section 157.24 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) PESTICIDE PROGRAMS PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES Child-Resistant Packaging § 157.24 Exemptions. (a) General exemptions...

  1. 21 CFR 822.30 - May I request exemption from the requirement to conduct postmarket surveillance?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Waivers and... model of that device at any time. You must comply with the requirements of this part unless and until we... exempt the device or model from postmarket surveillance. You should demonstrate why the surveillance...

  2. 21 CFR 822.30 - May I request exemption from the requirement to conduct postmarket surveillance?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Waivers and... model of that device at any time. You must comply with the requirements of this part unless and until we... exempt the device or model from postmarket surveillance. You should demonstrate why the surveillance...

  3. 9 CFR 317.400 - Exemption from nutrition labeling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Exemption from nutrition labeling. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.400 Exemption from nutrition labeling. (a) The following meat or meat food products are exempt from nutrition...

  4. 9 CFR 317.400 - Exemption from nutrition labeling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Exemption from nutrition labeling. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.400 Exemption from nutrition labeling. (a) The following meat or meat food products are exempt from nutrition...

  5. 9 CFR 317.400 - Exemption from nutrition labeling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Exemption from nutrition labeling. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.400 Exemption from nutrition labeling. (a) The following meat or meat food products are exempt from nutrition...

  6. 78 FR 14013 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Wheelchair Elevator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ...: General Requirements for Safety-- Collateral Standard: Electromagnetic Compatibility--Requirements and... electromagnetic compatibility and electrical safety. Firms are now exempt from 510(k) requirements for vertical... Equipment--Part 1-2: General Requirements for Safety--Collateral Standard: Electromagnetic Compatibility...

  7. Alternative Fuels Data Center

    Science.gov Websites

    Idle Reduction Equipment Excise Tax Exemption Qualified on-board idle reduction devices and advanced insulation are exempt from the federal excise tax imposed on the retail sale of heavy-duty highway ) SmartWay Technology Program Federal Excise Tax Exemption website. The exemption applies to equipment that

  8. 78 FR 35937 - Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug...

  9. 78 FR 14557 - Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0010] Guidance for Industry and Food and Drug Administration Staff: Investigational Device Exemption Guidance for Retinal Prostheses; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  10. 78 FR 50489 - Petition for Exemption From the Vehicle Theft Prevention Standard; Volkswagen Group of America, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-19

    ...) petition for exemption of the Audi confidential vehicle line in accordance with 49 CFR part 543, Exemption... 2015 Audi vehicle line. The petition requested an exemption from parts- marking requirement pursuant to... the components of the antitheft device for its Audi vehicle line. Volkswagen will install its...

  11. 21 CFR 99.305 - Exemption from the requirement to file a supplemental application.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., BIOLOGICS, AND DEVICES FDA Action on Submissions, Requests, and Applications § 99.305 Exemption from the... exemption from the requirement of a supplemental application, FDA shall approve or deny the application. (1) If FDA does not act on the application for an exemption within the 60-day period, the application for...

  12. 21 CFR 99.305 - Exemption from the requirement to file a supplemental application.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., BIOLOGICS, AND DEVICES FDA Action on Submissions, Requests, and Applications § 99.305 Exemption from the... exemption from the requirement of a supplemental application, FDA shall approve or deny the application. (1) If FDA does not act on the application for an exemption within the 60-day period, the application for...

  13. 21 CFR 99.305 - Exemption from the requirement to file a supplemental application.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., BIOLOGICS, AND DEVICES FDA Action on Submissions, Requests, and Applications § 99.305 Exemption from the... exemption from the requirement of a supplemental application, FDA shall approve or deny the application. (1) If FDA does not act on the application for an exemption within the 60-day period, the application for...

  14. 21 CFR 99.305 - Exemption from the requirement to file a supplemental application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., BIOLOGICS, AND DEVICES FDA Action on Submissions, Requests, and Applications § 99.305 Exemption from the... exemption from the requirement of a supplemental application, FDA shall approve or deny the application. (1) If FDA does not act on the application for an exemption within the 60-day period, the application for...

  15. 9 CFR 317.400 - Exemption from nutrition labeling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Exemption from nutrition labeling. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.400 Exemption from nutrition labeling. Link to an amendment published at 75 FR 82165, Dec. 29, 2010. (a) The...

  16. 9 CFR 317.400 - Exemption from nutrition labeling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Exemption from nutrition labeling. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.400 Exemption from nutrition labeling. Link to an amendment published at 75 FR 82165, Dec. 29, 2010. This amendment...

  17. 21 CFR 822.30 - May I request exemption from the requirement to conduct postmarket surveillance?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... conduct postmarket surveillance? 822.30 Section 822.30 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES POSTMARKET SURVEILLANCE Waivers and Exemptions § 822.30 May I request exemption from the requirement to conduct postmarket surveillance? You may...

  18. 21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 872.9 Section 872.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General...

  19. 21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 872.9 Section 872.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General...

  20. 21 CFR 872.3060 - Noble metal alloy.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... DEVICES DENTAL DEVICES Prosthetic Devices § 872.3060 Noble metal alloy. (a) Identification. A noble metal... “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the...

  1. 21 CFR 862.1795 - Vanilmandelic acid test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... certain hypertensive conditions. (b) Classification. Class I (general controls). The device is exempt from...

  2. Graphene electrodes for lithium-niobate electro-optic devices.

    PubMed

    Chang, Zeshan; Jin, Wei; Chiang, Kin Seng

    2018-04-15

    We propose and demonstrate the use of graphene electrodes for lithium-niobate electro-optic (EO) devices to exempt the need of incorporating a buffer layer between the waveguide and the electrodes. Using graphene electrodes, our experimental mode converter, based on an EO-generated long-period grating in a LiNbO 3 waveguide, shows a reduction in the half-π voltage by almost three times, compared with the conventional electrode design using metal. With the buffer layer exempted, the device fabrication process is also significantly simplified. The use of graphene electrodes is an effective approach to enhancing the efficiency of EO devices and, at the same time, reducing their fabrication cost.

  3. 49 CFR 385.815 - Exemption for AOBRD users.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... the AOBRDs currently in its CMVs or install new devices compliance with § 395.16 of this chapter. (d... to ongoing FMCSA oversight. (e) The exemption granted under this section shall not apply to CMVs...

  4. 49 CFR 385.815 - Exemption for AOBRD users.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... the AOBRDs currently in its CMVs or install new devices compliance with § 395.16 of this chapter. (d... to ongoing FMCSA oversight. (e) The exemption granted under this section shall not apply to CMVs...

  5. 21 CFR 862.1490 - Lysozyme (muramidase) test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... monocytic leukemia and kidney disease. (b) Classification. Class I (general controls). The device is exempt...

  6. 21 CFR 862.1500 - Malic dehydrogenase test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... marrow) leukemia. (b) Classification. Class I (general controls). The device is exempt from the premarket...

  7. 21 CFR 862.1380 - Hydroxybutyric dehydrogenase test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

  8. 21 CFR 862.1330 - Globulin test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... other disorders of blood globulins. (b) Classification. Class I (general controls). The device is exempt...

  9. 21 CFR 862.1470 - Lipid (total) test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.... (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

  10. 21 CFR 862.1805 - Vitamin A test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862.... (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

  11. 21 CFR 862.1605 - Pregnanediol test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

  12. 21 CFR 862.1395 - 17-Hydroxyprogesterone test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test... adrenal glands or the ovaries. (b) Classification. Class I (general controls). The device is exempt from...

  13. 21 CFR 862.1590 - Porphobilinogen test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

  14. 21 CFR 862.1790 - Uroporphyrin test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

  15. 21 CFR 862.1595 - Porphyrins test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

  16. 21 CFR 862.1325 - Gastrin test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862...-secreting tumor of the pancreas). (b) Classification. Class I (general controls). The device is exempt from...

  17. 21 CFR 862.1620 - Progesterone test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test Systems § 862... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

  18. 21 CFR 886.3100 - Ophthalmic tantalum clip.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... blood vessels in the eye. (b) Classification. Class II (special controls). The device is exempt from the...) MEDICAL DEVICES OPHTHALMIC DEVICES Prosthetic Devices § 886.3100 Ophthalmic tantalum clip. (a) Identification. An ophthalmic tantalum clip is a malleable metallic device intended to be implanted permanently...

  19. 21 CFR 886.1380 - Diagnostic condensing lens.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... light from the fundus of the eye. (b) Classification. Class I (general controls). The device is exempt...) MEDICAL DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1380 Diagnostic condensing lens. (a) Identification. A diagnostic condensing lens is a device used in binocular indirect ophthalmoscopy (a procedure...

  20. 77 FR 32644 - Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-01

    ... elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are... inclined platform lifts and vertical platform lifts), classified under 21 CFR 890.3930. IV. Comments...

  1. 21 CFR 872.6570 - Impression tube.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6570 Impression tube. (a) Identification. An impression tube is a device consisting of a hollow copper tube intended to take an impression of a single tooth...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

  2. 21 CFR 886.1770 - Manual refractor.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1770 Manual refractor. (a) Identification. A manual refractor is a device that is a set of lenses of varous dioptric powers intended to measure the refractive error of the eye. (b) Classification. Class I (general controls). The device is exempt from the...

  3. 77 FR 2555 - Guidance for Industry: Preparation of Investigational Device Exemptions and Investigational New...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-18

    ... editorial changes were made to improve clarity. Some terminology was changed to harmonize terminology within.../MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm , or http://www.regulations.gov...

  4. 27 CFR 479.33 - Special exemption.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2012-04-01 2010-04-01 true Special exemption. 479.33 Section 479.33 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND CERTAIN...

  5. 27 CFR 479.33 - Special exemption.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2014-04-01 2014-04-01 false Special exemption. 479.33 Section 479.33 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND CERTAIN...

  6. 27 CFR 479.33 - Special exemption.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2010-04-01 2010-04-01 false Special exemption. 479.33 Section 479.33 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND CERTAIN...

  7. 27 CFR 479.33 - Special exemption.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2011-04-01 2010-04-01 true Special exemption. 479.33 Section 479.33 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND CERTAIN...

  8. 27 CFR 479.33 - Special exemption.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2013-04-01 2013-04-01 false Special exemption. 479.33 Section 479.33 Alcohol, Tobacco Products, and Firearms BUREAU OF ALCOHOL, TOBACCO, FIREARMS, AND EXPLOSIVES, DEPARTMENT OF JUSTICE FIREARMS AND AMMUNITION MACHINE GUNS, DESTRUCTIVE DEVICES, AND CERTAIN...

  9. A two-in-one Faraday rotator mirror exempt of active optical alignment.

    PubMed

    Wan, Qiong; Wan, Zhujun; Liu, Hai; Liu, Deming

    2014-02-10

    A two-in-one Faraday rotator mirror was presented, which functions as two independent Faraday rotation mirrors with a single device. With the introduction of a reflection lens as substitution of the mirror in traditional structure, this device is characterized by exemption of active optical alignment for the designers and manufacturers of Faraday rotator mirrors. A sample was fabricated by passive mechanical assembly. The insertion loss was measured as 0.46 dB/0.50 dB for the two independent ports, respectively.

  10. 21 CFR 886.1430 - Ophthalmic contact lens radius measuring device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Ophthalmic contact lens radius measuring device... lens radius measuring device. (a) Identification. An ophthalmic contact lens radius measuring device is... lens. (b) Classification. Class I (general controls). The device is exempt from the premarket...

  11. 21 CFR 886.4300 - Intraocular lens guide.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) MEDICAL DEVICES OPHTHALMIC DEVICES Surgical Devices § 886.4300 Intraocular lens guide. (a) Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct... lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  12. 21 CFR 886.1500 - Headband mirror.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DEVICES OPHTHALMIC DEVICES Diagnostic Devices § 886.1500 Headband mirror. (a) Identification. A headband mirror is a device intended to be strapped to the head of the user to reflect light for use in examination of the eye. (b) Classification. Class I (general controls). The device is exempt from the...

  13. Performing clinical studies involving hernia mesh devices: what every investigator should know about the FDA investigational device exemption (IDE) process.

    PubMed

    Ashar, B S; Dang, J M; Krause, D; Luke, M C

    2011-12-01

    The FDA's Center for Devices and Radiological Health (CDRH) is responsible for providing reasonable assurance of safety and effectiveness of all medical devices marketed within the US. To date, CDRH has cleared numerous hernia mesh devices for general use, but has not cleared/approved any mesh devices intended for certain specific uses, such as for infected wounds, hernia prevention, biofilm reduction, or prevention of adhesions. CDRH is requesting that manufacturers seeking specific hernia mesh device labeling claims consult with the Agency to determine the level of evidence necessary for justifying such claims.

  14. 21 CFR 886.1810 - Tangent screen (campimeter).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square... a patient's visual field. This generic type of device includes projection tangent screens, target... (general controls). The AC-powered device and the battery-powered device are exempt from the premarket...

  15. 21 CFR 886.1810 - Tangent screen (campimeter).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square... a patient's visual field. This generic type of device includes projection tangent screens, target... (general controls). The AC-powered device and the battery-powered device are exempt from the premarket...

  16. 21 CFR 886.1810 - Tangent screen (campimeter).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square... a patient's visual field. This generic type of device includes projection tangent screens, target... (general controls). The AC-powered device and the battery-powered device are exempt from the premarket...

  17. 21 CFR 886.1810 - Tangent screen (campimeter).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Identification. A tangent screen (campimeter) is an AC-powered or battery-powered device that is a large square... a patient's visual field. This generic type of device includes projection tangent screens, target... (general controls). The AC-powered device and the battery-powered device are exempt from the premarket...

  18. 21 CFR 880.6890 - General purpose disinfectants.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin. (b) Classification. Class I (general controls). The device is exempt...

  19. 21 CFR 807.25 - Information required for device establishment registration and device listing.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... other provision of the Federal Food, Drug, and Cosmetic Act. (g) Device listing information must be... establishment under the ownership and control of the owner or operator where the device is manufactured..., Drug, and Cosmetic Act, which includes devices that are not exempt from premarket notification and...

  20. 21 CFR 807.25 - Information required for device establishment registration and device listing.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... other provision of the Federal Food, Drug, and Cosmetic Act. (g) Device listing information must be... establishment under the ownership and control of the owner or operator where the device is manufactured..., Drug, and Cosmetic Act, which includes devices that are not exempt from premarket notification and...

  1. 77 FR 70168 - Guidance for Industry and Food and Drug Administration Staff; The Content of Investigational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-23

    ...The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.'' FDA is issuing this guidance to inform industry and Agency staff of its recommendations for analytical and clinical performance studies to support premarket submissions for artificial pancreas systems.

  2. 78 FR 19363 - Petition for Exemption From the Vehicle Theft Prevention Standard; Honda

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-29

    ... immobilizer device occurs automatically when the vehicle is started without any further action by the driver... From the Vehicle Theft Prevention Standard; Honda AGENCY: National Highway Traffic Safety... Honda Civic vehicle line in accordance with 49 CFR part 543, Exemption from the Theft Prevention...

  3. 21 CFR 880.5300 - Medical absorbent fiber.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...'s body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category. (b) Classification. Class I (general controls). The device is exempt from the...

  4. 21 CFR 880.5300 - Medical absorbent fiber.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...'s body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category. (b) Classification. Class I (general controls). The device is exempt from the...

  5. 21 CFR 880.5300 - Medical absorbent fiber.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...'s body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category. (b) Classification. Class I (general controls). The device is exempt from the...

  6. 21 CFR 874.4100 - Epistaxis balloon.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    .... An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal... (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

  7. 21 CFR 868.6175 - Cardiopulmonary emergency cart.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...

  8. 21 CFR 868.6175 - Cardiopulmonary emergency cart.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...

  9. 21 CFR 868.6175 - Cardiopulmonary emergency cart.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...

  10. 21 CFR 868.6175 - Cardiopulmonary emergency cart.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...

  11. 21 CFR 868.6175 - Cardiopulmonary emergency cart.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... cardiopulmonary resuscitation. (b) Classification. Class I (general controls). The device is exempt from the... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Cardiopulmonary emergency cart. 868.6175 Section... (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Miscellaneous § 868.6175 Cardiopulmonary emergency cart...

  12. 21 CFR 900.2 - Definitions.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... a scientific study conducted in accordance with FDA's investigational device exemption regulations..., regardless of whether the person is referred by a physician or is self-referred. (jj) Phantom means a test..., instructors in a post-high school training institution and manufacturer's representatives. (pp) Quality...

  13. 21 CFR 870.2390 - Phonocardiograph.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...

  14. 21 CFR 870.2390 - Phonocardiograph.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...

  15. 21 CFR 870.2390 - Phonocardiograph.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...

  16. 21 CFR 870.2390 - Phonocardiograph.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...

  17. 21 CFR 870.2390 - Phonocardiograph.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Identification. A phonocardiograph is a device used to amplify or condition the signal from a heart sound... display of the heart sounds. (b) Classification. Class I (general controls). The device is exempt from the...

  18. 26 CFR 44.4402-1 - Exemptions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... section 4401 on any wager placed in a coin-operated device (as defined in section 4462 as in effect for... similar object, to operate a device described in section 4462(a)(2) (as so in effect). These devices... or tokens, has the features and characteristics of a gaming device whether or not evidence exists as...

  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

    ... vasculature via partial occlusion of the descending aorta, including in patients with acute ischemic stroke... device is placed in the descending aorta. On March 30, 2005, a Humanitarian Device Exemption application... selectively stopping or controlling flow in the peripheral vasculature, which includes the descending aorta...

  20. 21 CFR 874.5550 - Powered nasal irrigator.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...

  1. 21 CFR 874.5550 - Powered nasal irrigator.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...

  2. 21 CFR 874.5550 - Powered nasal irrigator.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...

  3. 21 CFR 874.5550 - Powered nasal irrigator.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...

  4. 21 CFR 874.5550 - Powered nasal irrigator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle. (b) Classification. Class I (general controls). The device is exempt from...

  5. 21 CFR 862.1305 - Formiminoglutamic acid (FIGLU) test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... measurements obtained by this device are used in the diagnosis of anemias, such as pernicious anemia and congenital hemolytic anemia. (b) Classification. Class I (general controls). The device is exempt from the...

  6. 21 CFR 862.1305 - Formiminoglutamic acid (FIGLU) test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... measurements obtained by this device are used in the diagnosis of anemias, such as pernicious anemia and congenital hemolytic anemia. (b) Classification. Class I (general controls). The device is exempt from the...

  7. 21 CFR 876.5210 - Enema kit.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... to promote evacuation of the contents of the lower colon. The device consists of a container for... irrigation system (§ 876.5220). (b) Classification. Class I (general controls). The device is exempt from the...

  8. Technology Readiness Assessment (TRA) Deskbook

    DTIC Science & Technology

    2009-07-01

    Document CDER Center for Drug Evaluation and Research CDR Critical Design Review CDRH Center for Devices and Radiologic Health CFD computational fluid...gational Device Exemption (IDE) meeting is held with Center for Devices and Radiological Health ( CDRH ) for proposed Class III devices, and the IDE...is prepared and submitted to CDRH . For a 510(k), determine substantially equivalent devices and their classification, validate func- tioning model

  9. 21 CFR 862.2400 - Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND... element on a radiochromatogram. (b) Classification. Class I (general controls). The device is exempt from...

  10. 21 CFR 862.2400 - Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND... element on a radiochromatogram. (b) Classification. Class I (general controls). The device is exempt from...

  11. 21 CFR 862.2400 - Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND... element on a radiochromatogram. (b) Classification. Class I (general controls). The device is exempt from...

  12. 77 FR 22384 - Petition To Modify an Exemption of a Previously Approved Antitheft Device; Porsche

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-13

    ... passive, microprocessor-based device which includes a starter interrupt function, transponder key and a.... Porsche stated that the antitheft system consists of two major subsystems: a microprocessor-based...

  13. 75 FR 22174 - Petition To Modify an Exemption of a Previously Approved Antitheft Device; Porsche

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-27

    ... passive antitheft device installed on the Porsche Panamera includes a microprocessor-based immobilizer... modified antitheft system will now consist of a microprocessor based immobilizer system which prevents...

  14. 21 CFR 886.1350 - Keratoscope.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device... subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice...

  15. 21 CFR 886.1350 - Keratoscope.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device... subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice...

  16. 21 CFR 886.1350 - Keratoscope.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device... subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice...

  17. 21 CFR 886.1350 - Keratoscope.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device... subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice...

  18. 21 CFR 886.1350 - Keratoscope.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device... subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice...

  19. 16 CFR § 1500.85 - Exemptions from classification as banned hazardous substances.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... component has no hazards other than being in a self-pressurized container. (8) Model rocket propellant devices designed for use in light-weight, recoverable, and reflyable model rockets, provided such devices... recovery system activation devices intended for use with premanufactured model rocket engines wherein all...

  20. 16 CFR 1500.85 - Exemptions from classification as banned hazardous substances.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... component has no hazards other than being in a self-pressurized container. (8) Model rocket propellant devices designed for use in light-weight, recoverable, and reflyable model rockets, provided such devices... recovery system activation devices intended for use with premanufactured model rocket engines wherein all...

  1. 16 CFR 1500.85 - Exemptions from classification as banned hazardous substances.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... component has no hazards other than being in a self-pressurized container. (8) Model rocket propellant devices designed for use in light-weight, recoverable, and reflyable model rockets, provided such devices... recovery system activation devices intended for use with premanufactured model rocket engines wherein all...

  2. 21 CFR 872.3730 - Pantograph.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... lower jaw. (b) Classification. Class I (general controls). The device is exempt from the premarket... intended to be attached to a patient's head to duplicate lower jaw movements to aid in construction of restorative and prosthetic dental devices. A marking pen is attached to the lower jaw component of the device...

  3. 21 CFR 874.5840 - Antistammering device.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... it senses the user's speech and that is intended to prevent the user from hearing the sounds of his or her own voice. The device is used to minimize a user's involuntary hesitative or repetitive speech. (b) Classification. Class I (general controls). The device is exempt from the premarket notification...

  4. 75 FR 6253 - Petition for Exemption From the Federal Motor Vehicle Theft Prevention Standard; Hyundia-Kia...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-08

    ...This document grants in full the Hyundai-Kia Motors Corporation (HATCI) petition for exemption of the Hyundai VI vehicle line in accordance with 49 CFR part 543, Exemption from Vehicle Theft Prevention Standard. This petition is granted because the agency has determined that the antitheft device to be placed on the line as standard equipment is likely to be as effective in reducing and deterring motor vehicle theft as compliance with the parts-marking requirements of 49 CFR part 541, Federal Motor Vehicle Theft Prevention Standard.

  5. 21 CFR 888.4600 - Protractor for clinical use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. A protractor for clinical use is a device intended for use in measuring the angles of bones, such as on x-rays or in surgery. (b) Classification. Class I (general controls). The device is exempt from...

  6. 77 FR 71028 - Parts and Accessories Necessary for Safe Operation; Grant of Exemption for Transecurity LLC...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-28

    ... Carrier Safety Regulations (FMCSRs) currently require antennas, transponders, and similar devices to be... the driver's field of view by devices mounted at the top of the windshield. Antennas, transponders and...

  7. Humanitarian Use Device and Humanitarian Device Exemption regulatory programs: pros and cons.

    PubMed

    Bernad, Daniel Maxwell

    2009-03-01

    The US FDA established the Humanitarian Use Device (HUD) and Humanitarian Device Exemption (HDE) program to encourage medical device firms to address rare diseases. Despite being in existence for over a decade, there has only been one peer-reviewed publication examining this field. The objective of this report is to investigate how the HUD/HDE program differs from the standard regulatory system, discuss its potential advantages and disadvantages, and to speculate which humanitarian devices will be brought to market within the next 5 years. A total of 40 semistructured interviews with stakeholders, representing approximately half (n = 20, 49%) of the firms that have successfully obtained HDE-approved products, were performed in order to acquire the primary data for this paper. There appear to be short-term gains and long-term drains associated with launching humanitarian devices to market. This report aims to provide sponsors with information that may allow them to make better decisions during their product development of humanitarian devices and may, hopefully, also play a role in encouraging other sponsors to take the necessary steps forward in helping to find treatments for patients with rare diseases.

  8. 77 FR 35112 - Petition To Modify an Exemption of a Previously Approved Antitheft Device; Ford Motor Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-12

    ... stated that the Fusion Titanium trim and Fusion Hybrid vehicles will be equipped with the IAwPB system as... Standard for the Ford Fusion vehicle line beginning with its model year (MY) 2012 vehicles. On February 16, 2012, Ford submitted a petition to modify its previously approved exemption for the Ford Fusion vehicle...

  9. 78 FR 53498 - Petition for Exemption From the Vehicle Theft Prevention Standard; Fuji Heavy Industries U.S.A...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-29

    ... identity, design, and location of the components of the antitheft device for the Subaru [confidential.... Additionally, FUSA stated that because the immobilization features are designed and constructed within the... provided a comparative table showing how its device is similar to other manufacturers' devices that have...

  10. 27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

  11. 27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

  12. 27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

  13. 27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

  14. 27 CFR 478.153 - Semiautomatic assault weapons and large capacity ammunition feeding devices manufactured or...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... weapons and large capacity ammunition feeding devices manufactured or imported for the purposes of testing... AMMUNITION Exemptions, Seizures, and Forfeitures § 478.153 Semiautomatic assault weapons and large capacity... weapon, and § 478.40a with respect to large capacity ammunition feeding devices, shall not apply to the...

  15. 21 CFR 884.5150 - Nonpowered breast pump.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... device used to express milk from the breast. (b) Classification. Class I. The device is exempt from the... 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Nonpowered breast pump. 884.5150 Section 884.5150...

  16. 21 CFR 884.5150 - Nonpowered breast pump.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... device used to express milk from the breast. (b) Classification. Class I. The device is exempt from the... 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Nonpowered breast pump. 884.5150 Section 884.5150...

  17. 21 CFR 884.5150 - Nonpowered breast pump.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... device used to express milk from the breast. (b) Classification. Class I. The device is exempt from the... 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Nonpowered breast pump. 884.5150 Section 884.5150...

  18. 21 CFR 884.5150 - Nonpowered breast pump.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... device used to express milk from the breast. (b) Classification. Class I. The device is exempt from the... 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Nonpowered breast pump. 884.5150 Section 884.5150...

  19. 21 CFR 884.5150 - Nonpowered breast pump.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... device used to express milk from the breast. (b) Classification. Class I. The device is exempt from the... 250 mm Hg suction, and the device materials that contact breast or breast milk do not produce... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Nonpowered breast pump. 884.5150 Section 884.5150...

  20. Activation of QA devices and phantom materials under clinical scanning proton beams—a gamma spectrometry study

    NASA Astrophysics Data System (ADS)

    Hanušová, Tereza; Johnová, Kamila; Navrátil, Matěj; Valenta, Jiří; Müller, Lutz

    2018-06-01

    Activation of detectors and phantoms used for commissioning and quality assurance of clinical proton beams may lead to radiation protection issues. Good understanding of the activation nuclide vectors involved is necessary to assess radiation risk for the personnel working with these devices on a daily basis or to fulfill legal requirements regarding transport of radioactive material and its release to the public. 11 devices and material samples were irradiated with a 220 MeV proton pencil beam (PBS, Proton Therapy Center, Prague). This study focuses on devices manufactured by IBA Dosimetry GmbH: MatriXX PT, PPC05, Stingray, Zebra, Lynx, a Blue Phantom rail and samples of RW3, PMMA, titanium, copper and carbon fibre plastic. Monitor units (MU) were monitored during delivery. Gamma spectrometry was then performed for each item using a HPGe detector, with a focus on longer lived gamma emitting radionuclides. Activities were quantified for all found isotopes and compared to relevant legal limits for exemption and clearance of radioactive objects. Activation was found to be significant after long irradiation sessions, as done during commissioning of a proton therapy room. Some of the investigated devices may also cumulate activity in time, depending on the scenario of periodic irradiation in routine clinical practice. However, the levels of activity and resulting beta/gamma doses are more comparable to internationally recommended concentration limits for exemption than to dose limits for radiation workers. Results of this study will help to determine nuclide inventories required by some legal authorities for radiation protection purposes.

  1. Activation of QA devices and phantom materials under clinical scanning proton beams-a gamma spectrometry study.

    PubMed

    Hanušová, Tereza; Johnová, Kamila; Navrátil, Matěj; Valenta, Jiří; Müller, Lutz

    2018-06-07

    Activation of detectors and phantoms used for commissioning and quality assurance of clinical proton beams may lead to radiation protection issues. Good understanding of the activation nuclide vectors involved is necessary to assess radiation risk for the personnel working with these devices on a daily basis or to fulfill legal requirements regarding transport of radioactive material and its release to the public. 11 devices and material samples were irradiated with a 220 MeV proton pencil beam (PBS, Proton Therapy Center, Prague). This study focuses on devices manufactured by IBA Dosimetry GmbH: MatriXX PT, PPC05, Stingray, Zebra, Lynx, a Blue Phantom rail and samples of RW3, PMMA, titanium, copper and carbon fibre plastic. Monitor units (MU) were monitored during delivery. Gamma spectrometry was then performed for each item using a HPGe detector, with a focus on longer lived gamma emitting radionuclides. Activities were quantified for all found isotopes and compared to relevant legal limits for exemption and clearance of radioactive objects. Activation was found to be significant after long irradiation sessions, as done during commissioning of a proton therapy room. Some of the investigated devices may also cumulate activity in time, depending on the scenario of periodic irradiation in routine clinical practice. However, the levels of activity and resulting beta/gamma doses are more comparable to internationally recommended concentration limits for exemption than to dose limits for radiation workers. Results of this study will help to determine nuclide inventories required by some legal authorities for radiation protection purposes.

  2. 78 FR 76702 - Parts and Accessories Necessary for Safe Operation; Application for an Exemption From Volvo...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-18

    ... Regulations (FMCSRs) currently require antennas, transponders, and similar devices to be located not more than... the driver's field of view by devices mounted at the top of the windshield. Antennas, transponders and...

  3. 21 CFR 808.1 - Scope.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...(a) does not preempt State or local provisions respecting delegations of authority and related... FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS General Provisions § 808.1 Scope... exemption from Federal preemption of State and local requirements applicable to medical devices under...

  4. 21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY...

  5. 21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY...

  6. 21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY...

  7. 21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). 866.9 Section 866.9 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES IMMUNOLOGY AND MICROBIOLOGY...

  8. 78 FR 46406 - Parts and Accessories Necessary for Safe Operation; Application for an Exemption From Help, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-31

    ... Regulations (FMCSRs) currently require antennas, transponders, and similar devices to be located not more than.... Antennas, transponders and similar devices must not be mounted more than 152 mm (6 inches) below the upper...

  9. 21 CFR 862.1365 - Glutathione test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ....1365 Glutathione test system. (a) Identification. A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid) in erythrocytes (red blood... I (general controls). The device is exempt from the premarket notification procedures in subpart E...

  10. 21 CFR 862.1365 - Glutathione test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ....1365 Glutathione test system. (a) Identification. A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid) in erythrocytes (red blood... I (general controls). The device is exempt from the premarket notification procedures in subpart E...

  11. 21 CFR 862.1365 - Glutathione test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ....1365 Glutathione test system. (a) Identification. A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid) in erythrocytes (red blood... I (general controls). The device is exempt from the premarket notification procedures in subpart E...

  12. 21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Medical devices for processing, repacking, or manufacturing. 801.122 Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND..., repacking, or use in the manufacture of another drug or device shall be exempt from section 502(f)(1) of the...

  13. 21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Medical devices for processing, repacking, or manufacturing. 801.122 Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND..., repacking, or use in the manufacture of another drug or device shall be exempt from section 502(f)(1) of the...

  14. 21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Medical devices for processing, repacking, or manufacturing. 801.122 Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND..., repacking, or use in the manufacture of another drug or device shall be exempt from section 502(f)(1) of the...

  15. 21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Medical devices for processing, repacking, or manufacturing. 801.122 Section 801.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND..., repacking, or use in the manufacture of another drug or device shall be exempt from section 502(f)(1) of the...

  16. 21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND... purpose, or the device is intended for lay use where the former intended use was by health care... of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic...

  17. 21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  18. 21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND... purpose, or the device is intended for lay use where the former intended use was by health care... of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic...

  19. 21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  20. 21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  1. 21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  2. 21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND... purpose, or the device is intended for lay use where the former intended use was by health care... of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic...

  3. 21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  4. 21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  5. 21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  6. 21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  7. 21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GASTROENTEROLOGY-UROLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  8. 21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND... purpose, or the device is intended for lay use where the former intended use was by health care... of immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic...

  9. 21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  10. 21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES HEMATOLOGY AND PATHOLOGY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  11. 21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OBSTETRICAL AND GYNECOLOGICAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  12. 21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

  13. 21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

  14. 21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

  15. 21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

  16. 21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

  17. 21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

  18. 21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

  19. 21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

  20. 21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... device operates using a different fundamental scientific technology than a legally marketed device in... cardiovascular diseases; (5) For use in diabetes management; (6) For identifying or inferring the identity of a...

  1. 21 CFR 864.6600 - Osmotic fragility test.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

  2. 21 CFR 864.6600 - Osmotic fragility test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

  3. 21 CFR 864.6600 - Osmotic fragility test.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

  4. 21 CFR 864.6600 - Osmotic fragility test.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

  5. 21 CFR 864.6600 - Osmotic fragility test.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... test. (a) Identification. An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

  6. 40 CFR 63.2250 - What are the general requirements?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., except during periods of process unit or control device startup, shutdown, and malfunction; prior to process unit initial startup; and during the routine control device maintenance exemption specified in... practice requirements are not operating, or during periods of startup, shutdown, and malfunction. Startup...

  7. 40 CFR 63.2250 - What are the general requirements?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., except during periods of process unit or control device startup, shutdown, and malfunction; prior to process unit initial startup; and during the routine control device maintenance exemption specified in... practice requirements are not operating, or during periods of startup, shutdown, and malfunction. Startup...

  8. 40 CFR 63.2250 - What are the general requirements?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., except during periods of process unit or control device startup, shutdown, and malfunction; prior to process unit initial startup; and during the routine control device maintenance exemption specified in... practice requirements are not operating, or during periods of startup, shutdown, and malfunction. Startup...

  9. M6-C artificial disc placement.

    PubMed

    Coric, Domagoj; Parish, John; Boltes, Margaret O

    2017-01-01

    There has been a steady evolution of cervical total disc replacement (TDR) devices over the last decade resulting in surgical technique that closely mimics anterior cervical discectomy and fusion as well as disc design that emphasizes quality of motion. The M6-C TDR device is a modern-generation artificial disc composed of titanium endplates with tri-keel fixation as well as a polyethylene weave with a polyurethane core. Although not yet approved by the FDA, M6-C has finished a pilot and pivotal US Investigational Device Exemption (IDE) study. The authors present the surgical technique for implantation of a 2-level M6-C cervical TDR device. The video can be found here: https://youtu.be/rFEAqINLRCo .

  10. 77 FR 52043 - Privacy Act of 1974; Proposed Exempt New System of Records

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-28

    ... study. 6. After NIH makes a finding of research misconduct and has informed ORI of the finding... Internet traffic to and from federal computer networks to prevent malicious computer code from reaching the... portable/ mobile devices including, but not limited to: Laptops, PDAs, USB drives, portable hard drives...

  11. The Examination of Real Property Tax Exemptions: An Example of Land Use Planning for Fiscal Gain. Exchange Bibliography No. 172.

    ERIC Educational Resources Information Center

    Martin, Larry R. G.

    This selected bibliography focuses on property tax exemptions in urban areas and on the ability of cities to generate property tax revenues. It begins with a review of some relationships between the property tax and land use planning. Then, the role of the property tax as one of several devices employed in fiscally-oriented planning is examined.…

  12. 21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  13. 21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  14. 21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  15. 21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  16. 21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  17. 21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  18. 21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  19. 21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY... device is intended for lay use where the former intended use was by health care professionals only; (b... immunohistochemical devices; (2) For use in screening or diagnosis of familial or acquired genetic disorders...

  20. 75 FR 50036 - Petition To Modify an Exemption of a Previously Approved Antitheft Device; Ford Motor Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-16

    ... standard equipment or the optional Intelligent Access with Push Button Start (IAwPB). Key components of the... and reports back to the BCM whether a valid key was found. In both devices, if the codes do not match...

  1. 21 CFR 880.2920 - Clinical mercury thermometer.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

  2. 21 CFR 880.2920 - Clinical mercury thermometer.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

  3. 21 CFR 880.2920 - Clinical mercury thermometer.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

  4. 21 CFR 880.2920 - Clinical mercury thermometer.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Clinical mercury thermometer. 880.2920 Section 880... Devices § 880.2920 Clinical mercury thermometer. (a) Identification. A clinical mercury thermometer is a... mercury. (b) Classification. Class II (special controls). The device is exempt from the premarket...

  5. 21 CFR 862.1670 - Sorbitol dehydrogenase test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Systems § 862.1670 Sorbitol dehydrogenase test system. (a) Identification. A sorbitol dehydrogenase test system is a device intended to measure the activity of the enzyme sorbitol dehydrogenase in serum... cirrhosis or acute hepatitis. (b) Classification. Class I (general controls). The device is exempt from the...

  6. 21 CFR 880.5630 - Nipple shield.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  7. 21 CFR 880.5630 - Nipple shield.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  8. 21 CFR 880.5630 - Nipple shield.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  9. 21 CFR 880.5630 - Nipple shield.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  10. 21 CFR 880.5630 - Nipple shield.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  11. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

  12. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

  13. 21 CFR 862.1650 - Pyruvate kinase test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  14. 21 CFR 862.1650 - Pyruvate kinase test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  15. 21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

  16. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

  17. 21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

  18. 21 CFR 862.1650 - Pyruvate kinase test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  19. 21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

  20. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... survival of mature red blood cells and inability of the bone marrow to compensate for their decreased life span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt... Hemopexin immunological test system. (a) Indentification. A hemopexin immunological test system is a device...

  1. 21 CFR 862.1650 - Pyruvate kinase test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  2. 21 CFR 862.1650 - Pyruvate kinase test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ....1650 Pyruvate kinase test system. (a) Identification. A pyruvate kinase test system is a device intended to measure the activity of the enzyme pyruvate kinase in erythrocytes (red blood cells...). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  3. 21 CFR 866.5360 - Cohn fraction IV immuno-logical test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...-lipoprotein), malnutrition, iron deficiency anemia, red blood cell disorders, and kidney disease. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in... test system is a device that consists of or measures that fraction of plasma proteins, predominantly...

  4. 40 CFR 63.2250 - What are the general requirements?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... periods of process unit or control device startup, shutdown, and malfunction; prior to process unit initial startup; and during the routine control device maintenance exemption specified in § 63.2251. The... are not operating, or during periods of startup, shutdown, and malfunction. Startup and shutdown...

  5. 40 CFR 63.2250 - What are the general requirements?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... periods of process unit or control device startup, shutdown, and malfunction; prior to process unit initial startup; and during the routine control device maintenance exemption specified in § 63.2251. The... are not operating, or during periods of startup, shutdown, and malfunction. Startup and shutdown...

  6. 21 CFR 880.6265 - Examination gown.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Examination gown. 880.6265 Section 880.6265 Food... § 880.6265 Examination gown. (a) Identification. An examination gown is a device intended for medical... covering during a medical examination. (b) Classification. Class I (general controls). The device is exempt...

  7. 78 FR 14015 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-04

    ... for Safety--Collateral Standard: Electromagnetic Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety Standard for Platform Lifts and Stairway Chair Lifts'') must validate electromagnetic...: Electromagnetic Compatibility--Requirements and Tests,'' and ASME A18.1 ``Safety Standard for Platform Lifts and...

  8. 21 CFR 862.1720 - Triose phosphate isomerase test system.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... isomerase test system is a device intended to measure the activity of the enzyme triose phosphate isomerase in erythrocytes (red blood cells). Triose phosphate isomerase is an enzyme important in glycolysis... device is exempt from the premarket notification procedures in subpart E of part 807 subject to the...

  9. 21 CFR 862.1720 - Triose phosphate isomerase test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... isomerase test system is a device intended to measure the activity of the enzyme triose phosphate isomerase in erythrocytes (red blood cells). Triose phosphate isomerase is an enzyme important in glycolysis... device is exempt from the premarket notification procedures in subpart E of part 807 subject to the...

  10. 21 CFR 864.7675 - Leukocyte peroxidase test.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their... peroxidase test. (a) Identification. A leukocyte peroxidase test is a device used to distinguish certain... of the leukemias. (b) Classification. Class I (general controls). This device is exempt from the...

  11. 21 CFR 864.7675 - Leukocyte peroxidase test.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their... peroxidase test. (a) Identification. A leukocyte peroxidase test is a device used to distinguish certain... of the leukemias. (b) Classification. Class I (general controls). This device is exempt from the...

  12. 21 CFR 864.7675 - Leukocyte peroxidase test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their... peroxidase test. (a) Identification. A leukocyte peroxidase test is a device used to distinguish certain... of the leukemias. (b) Classification. Class I (general controls). This device is exempt from the...

  13. 21 CFR 864.7675 - Leukocyte peroxidase test.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their... peroxidase test. (a) Identification. A leukocyte peroxidase test is a device used to distinguish certain... of the leukemias. (b) Classification. Class I (general controls). This device is exempt from the...

  14. 21 CFR 864.7675 - Leukocyte peroxidase test.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their... peroxidase test. (a) Identification. A leukocyte peroxidase test is a device used to distinguish certain... of the leukemias. (b) Classification. Class I (general controls). This device is exempt from the...

  15. 21 CFR 862.1720 - Triose phosphate isomerase test system.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... isomerase test system is a device intended to measure the activity of the enzyme triose phosphate isomerase in erythrocytes (red blood cells). Triose phosphate isomerase is an enzyme important in glycolysis... device is exempt from the premarket notification procedures in subpart E of part 807 subject to the...

  16. 21 CFR 880.5090 - Liquid bandage.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

  17. 21 CFR 880.5090 - Liquid bandage.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

  18. 21 CFR 880.5090 - Liquid bandage.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

  19. 21 CFR 880.5090 - Liquid bandage.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

  20. 21 CFR 886.1200 - Optokinetic drum.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

  1. 21 CFR 886.1200 - Optokinetic drum.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

  2. 21 CFR 886.1200 - Optokinetic drum.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

  3. 21 CFR 886.1200 - Optokinetic drum.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

  4. 21 CFR 886.1200 - Optokinetic drum.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... optokinetic drum is a drum-like device covered with alternating white and dark stripes or pictures that can be... of the eyeball) in patients. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the...

  5. 21 CFR 880.5090 - Liquid bandage.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant. (b) Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E...

  6. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

  7. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

  8. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

  9. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

  10. 21 CFR 812.30 - FDA action on applications.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA action on applications. 812.30 Section 812.30...) MEDICAL DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Application and Administrative Action § 812.30 FDA action on applications. (a) Approval or disapproval. FDA will notify the sponsor in writing of the date...

  11. Guidance for the emergency use of unapproved medical devices; availability--FDA. Notice.

    PubMed

    1985-10-22

    The Food and Drug Administration (FDA) is announcing guidance, developed by FDA's Center for Devices and Radiological Health (CDRH), with respect to those emergency situations in which the agency would not object to a physician's using a potentially life-saving medical device for a use for which the device ordinarily is required to have, but does not have, an approved application for premarket approval or an investigational device exemption. The guidance is contained in a document entitled "guidance for the Emergency Use of Unapproved Medical Devices."

  12. Lessons Learned From The Investigational Device Exemption (IDE) Review of Children's Oncology Group Trial AAML1031

    PubMed Central

    Meshinchi, Soheil; Hunger, Stephen P.; Aplenc, Richard; Adamson, Peter C.; Jessup, J. Milburn

    2012-01-01

    The FDA is now exerting its regulatory authority over molecular diagnostics and their assays used for medical-decision making in clinical trials by performing pre-Investigational Device Exemption (IDE) reviews in all phases of clinical trials. This review assesses the analytical performance of the assay for the diagnostic and considers how that performance affects the diagnostic and the patient and their risks and benefits from treatment. This manuscript reviews the process of the first review that was performed on a new Children's Oncology Group (COG) Phase III trial in Acute Myelogenous Leukemia. The lessons learned and recommendations for how to prepare for and incorporate this new level of regulatory review into the protocol development process are presented. PMID:22422407

  13. Integrating Unmanned Aircraft Systems into Modern Policing in An Urban Environment

    DTIC Science & Technology

    2012-09-01

    University of Phoenix , 1994 Submitted in partial fulfillment of the requirements for the degree of MASTER OF ARTS IN SECURITY STUDIES (HOMELAND...PERSPECTIVE.................................................. 23 C. “ LIGHT ” UAS OPERATIONAL EXEMPTIONS ................................. 27 D...activity) utilizing a FLIR device capable of thermal imaging detection to determine if Kyllo was using powerful light to cultivate marijuana.37 The

  14. 21 CFR 99.205 - Application for exemption from the requirement to file a supplemental application.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... characterizing the safety and effectiveness of the drug or device, including data from the study described in the... effectiveness of the use, a summary of those data, and any documentation resulting from prior discussions with... minus the costs of goods sold and marketing and administrative expenses attributable to the new use of...

  15. 27 CFR 555.141 - Exemptions.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., fertilizers, propellant actuated devices, or propellant actuated industrial tools manufactured, imported, or distributed for their intended purposes. (9) Industrial and laboratory chemicals which are intended for use as...

  16. 27 CFR 555.141 - Exemptions.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., fertilizers, propellant actuated devices, or propellant actuated industrial tools manufactured, imported, or distributed for their intended purposes. (9) Industrial and laboratory chemicals which are intended for use as...

  17. 27 CFR 555.141 - Exemptions.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., fertilizers, propellant actuated devices, or propellant actuated industrial tools manufactured, imported, or distributed for their intended purposes. (9) Industrial and laboratory chemicals which are intended for use as...

  18. 21 CFR 870.4200 - Cardiopulmonary bypass accessory equipment.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ....4200 Section 870.4200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... class I if it does not involve an electrical connection to the patient. The device is exempt from the... (special controls). The device is classified as class II if it involves an electrical connection to the...

  19. 21 CFR 870.4200 - Cardiopulmonary bypass accessory equipment.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ....4200 Section 870.4200 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... class I if it does not involve an electrical connection to the patient. The device is exempt from the... (special controls). The device is classified as class II if it involves an electrical connection to the...

  20. 77 FR 1973 - Petition for Exemption From the Vehicle Theft Prevention Standard; Fuji Heavy Industries U.S.A...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-12

    ... description and diagram of the identity, design and location of the components of the antitheft device for the... the antitheft device and the immobilization features are constructed and designed within the vehicle's... test. Additionally, FUSA stated that since the immobilization features are designed and constructed...

  1. 21 CFR 864.6700 - Erythrocyte sedimentation rate test.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  2. 21 CFR 864.6700 - Erythrocyte sedimentation rate test.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  3. 21 CFR 864.6700 - Erythrocyte sedimentation rate test.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  4. 21 CFR 864.6700 - Erythrocyte sedimentation rate test.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  5. 21 CFR 864.6700 - Erythrocyte sedimentation rate test.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... sedimentation rate test. (a) Identification. An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a... device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter...

  6. 21 CFR 862.1255 - 2,3-Diphosphoglyceric acid test system.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... acid test system is a device intended to measure 2,3-diphosphoglyceric acid (2,3-DPG) in erythrocytes (red blood cells). Measurements of 2,3-diphosphoglyceric acid are used in the diagnosis and treatment... the quality of stored blood. (b) Classification. Class I (general controls). The device is exempt from...

  7. 21 CFR 812.42 - FDA and IRB approval.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

  8. 21 CFR 812.42 - FDA and IRB approval.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

  9. 21 CFR 812.42 - FDA and IRB approval.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

  10. 21 CFR 812.42 - FDA and IRB approval.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

  11. 21 CFR 812.42 - FDA and IRB approval.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false FDA and IRB approval. 812.42 Section 812.42 Food... DEVICES INVESTIGATIONAL DEVICE EXEMPTIONS Responsibilities of Sponsors § 812.42 FDA and IRB approval. A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both...

  12. 75 FR 39263 - Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-08

    ..., and Consumer Assistance (DSMICA), Center for Devices and Radiological Health (CDRH), Food and Drug... label to assist that office in processing your request, or fax your request to CDRH at 301-847-8149. The... the guidance you are requesting. A search capability for all CDRH guidance documents is available at...

  13. 21 CFR 864.3300 - Cytocentrifuge.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) Identification. A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g...) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

  14. 21 CFR 864.3300 - Cytocentrifuge.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification. A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g...) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in...

  15. 77 FR 25209 - Environmental Assessment and Finding of No Significant Impact for Exemption Request for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-27

    ... sealed source must either identify the source or device by manufacturer and model number as registered in...., Model Nos. 1862, 1864, and 1866 manual brachytherapy sources for medical uses authorized under the... that do not have an approved Sealed Source and Device Registry (SSDR). The NRC has determined that the...

  16. 75 FR 31837 - Petition for Exemption From the Vehicle Theft Prevention Standard; Mercedes-Benz

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-04

    ... agency comparing its proposed device to antitheft devices already installed in the Aston Martin Vantage... effective in contributing to a 63.5% reduction in the theft rate for the Aston Martin Vantage Line... Martin Vantage vehicle line and 0.6784 for the MY 2007. MBUSA also referenced theft data published by the...

  17. 21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  18. 21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  19. 21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  20. 21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  1. 21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  2. 21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  3. 21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  4. 21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  5. 21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  6. 21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  7. 21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  8. 21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  9. 21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  10. 21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  11. 21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  12. 21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  13. 21 CFR 886.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES OPHTHALMIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  14. 21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  15. 21 CFR 882.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES NEUROLOGICAL DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  16. 21 CFR 870.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES CARDIOVASCULAR DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  17. 21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  18. 21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  19. 21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  20. 21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  1. 21 CFR 872.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES DENTAL DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  2. 21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  3. 21 CFR 888.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ORTHOPEDIC DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  4. 21 CFR 890.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PHYSICAL MEDICINE DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  5. 21 CFR 868.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  6. 21 CFR 892.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES General... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  7. 21 CFR 864.9225 - Cell-freezing apparatus and reagents for in vitro diagnostic use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... use are devices used to freeze human red blood cells for in vitro diagnostic use. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E... Establishments That Manufacture Blood and Blood Products § 864.9225 Cell-freezing apparatus and reagents for in...

  8. 21 CFR 864.9225 - Cell-freezing apparatus and reagents for in vitro diagnostic use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... use are devices used to freeze human red blood cells for in vitro diagnostic use. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E... Establishments That Manufacture Blood and Blood Products § 864.9225 Cell-freezing apparatus and reagents for in...

  9. 21 CFR 864.9225 - Cell-freezing apparatus and reagents for in vitro diagnostic use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... use are devices used to freeze human red blood cells for in vitro diagnostic use. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E... Establishments That Manufacture Blood and Blood Products § 864.9225 Cell-freezing apparatus and reagents for in...

  10. 40 CFR 142.57 - Bottled water, point-of-use, and point-of-entry devices.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 23 2014-07-01 2014-07-01 false Bottled water, point-of-use, and point-of-entry devices. 142.57 Section 142.57 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) NATIONAL PRIMARY DRINKING WATER REGULATIONS IMPLEMENTATION Exemptions Issued by the Administrator § 142.57...

  11. 16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 101 of the Consumer Product Safety Improvement Act for certain electronic devices. 1500.88 Section... from lead limits under section 101 of the Consumer Product Safety Improvement Act for certain electronic devices. (a) The Consumer Product Safety Improvement Act (CPSIA) provides for specific lead limits...

  12. 21 CFR 862.1560 - Urinary phenylketones (nonquantitative) test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... and treatment of congenital phenylketonuria which, if untreated, may cause mental retardation. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

  13. 21 CFR 892.1910 - Radiographic grid.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor. (b) Classification. Class I (general controls). The device is exempt from the...

  14. 21 CFR 892.1910 - Radiographic grid.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor. (b) Classification. Class I (general controls). The device is exempt from the...

  15. 21 CFR 892.1910 - Radiographic grid.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor. (b) Classification. Class I (general controls). The device is exempt from the...

  16. 21 CFR 892.1910 - Radiographic grid.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor. (b) Classification. Class I (general controls). The device is exempt from the...

  17. 21 CFR 872.3220 - Facebow.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... for use in denture fabrication to determine the spatial relationship between the upper and lower jaws.... Class I (general controls). The device is exempt from the premarket notification procedures in subpart E...

  18. 21 CFR 880.5475 - Jet lavage.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., and a means of propelling the fluid through the tubing, such as an electric roller pump. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in...

  19. 21 CFR 880.5475 - Jet lavage.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., and a means of propelling the fluid through the tubing, such as an electric roller pump. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in...

  20. 21 CFR 886.3800 - Scleral shell.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually... controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  1. 21 CFR 886.3800 - Scleral shell.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually... controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  2. 21 CFR 886.3800 - Scleral shell.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... and proximal-cornea sclera for cosmetic or reconstructive purposes. An artificial eye is usually... controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  3. 21 CFR 866.5490 - Hemopexin immunological test system.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... diagnosis of various hematologic disorders, such as hemolytic anemia (anemia due to shortened in vivo... span) and sickle cell anemia. (b) Classification. Class II (special controls). The device is exempt...

  4. 77 FR 1782 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-11

    ... any personal information you provide. Using the search function of our docket web site, anyone can... systems without giving approval for automatic activation devices (AAD). Parachute Labs provides...

  5. 21 CFR 874.1800 - Air or water caloric stimulator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... vestibular function testing of a patient's body balance system. The vestibular stimulation of the...) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in...

  6. 21 CFR 872.3730 - Pantograph.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... and, as the patient's mouth opens, the pen records on graph paper the angle between the upper and the lower jaw. (b) Classification. Class I (general controls). The device is exempt from the premarket...

  7. 21 CFR 868.1575 - Gas collection vessel.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... for subsequent analysis. It does not include a sampling pump. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this...

  8. 21 CFR 876.5160 - Urological clamp for males.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... temporarily. It is an external clamp. (b) Classification. Class I (general controls). Except when intended for internal use or use on females, the device is exempt from the premarket notification procedures in subpart...

  9. 78 FR 56839 - Compatibility of Generally Licensed and Exempt Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-16

    ... 20852. FOR FURTHER INFORMATION CONTACT: Solomon Sahle, Office of Federal and State Materials and...-415- 3781, email: Solomon[email protected] . SUPPLEMENTARY INFORMATION: I. The Petition Section 2.802 of...

  10. 21 CFR 886.4070 - Powered corneal burr.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

  11. 21 CFR 886.4070 - Powered corneal burr.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

  12. 21 CFR 886.4070 - Powered corneal burr.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

  13. 21 CFR 886.4070 - Powered corneal burr.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

  14. 21 CFR 886.4070 - Powered corneal burr.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... to remove rust rings from the cornea of the eye. (b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in...

  15. 75 FR 3154 - Children's Products Containing Lead; Exemptions for Certain Electronic Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-20

    ..., some calculators, and certain computers or similar electronic learning products. 3. Certain Lead...: (1) Lead blended into the glass of cathode ray tubes, electronic components, and fluorescent tubes...

  16. 21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  17. 21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  18. 21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  19. 21 CFR 874.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES EAR, NOSE, AND THROAT DEVICES... for lay use where the former intended use was by health care professionals only; (b) The modified... use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of...

  20. Understanding United States Investigational Device Exemption Studies-Clinical Relevance and Importance for Healthcare Economics.

    PubMed

    Ament, Jared D; Mollan, Scott; Greenan, Krista; Binyamin, Tamar; Kim, Kee D

    2017-06-01

    The US Food and Drug Administration allows a previously unapproved device to be used clinically to collect safety and effectiveness data under their Investigational Device Exemption (IDE) category. The process usually falls under 3 different trial categories: noninferiority, equivalency, and superiority. To confidently inform our patients, understanding the basic concepts of these trials is paramount. The purpose of this manuscript was to provide a comprehensive review of these topics using recently published IDE trials and economic analyses of cervical total disc replacement as illustrative examples. In 2006, an IDE was initiated to study the safety and effectiveness of total disc replacement controlled against the standard of care, anterior cervical discectomy, and fusion. Under the IDE, randomized controlled trials comparing both 1 and 2 level cervical disease were completed. The sponsor designed the initial trial as noninferiority; however, using adaptive methodology, superiority could be claimed in the 2-level investigation. Healthcare economics are critical in medical decision making and reimbursement practices. Once both cost- and quality-adjusted life-year (QALY) are known for each patient, the incremental cost-effectiveness ratio is calculated. Willingness-to-pay is controversial, but a commonly cited guideline considers interventions costing below 20 000 $/QALY strongly cost effective and more than 100 000 $/QALY as not cost effective. While large Food and Drug Administration IDE studies are often besieged by complex statistical considerations and calculations, it is fundamentally important that clinicians understand at least the terminology and basic concepts on a practical level. Copyright © 2017 by the Congress of Neurological Surgeons

  1. 77 FR 65761 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-30

    ... an explosive or incendiary device; 6. The requirement for a designated location where a bomb or other... case of detonation (least risk bomb location); 7. The requirement that the passenger cabin be designed...

  2. 21 CFR 886.5820 - Closed-circuit television reading system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... of a lens, video camera, and video monitor that is intended for use by a patient who has subnormal vision to magnify reading material. (b) Classification. Class I (general controls). The device is exempt...

  3. 21 CFR 888.4800 - Template for clinical use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... cutting. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9. [52 FR...

  4. 47 CFR 15.205 - Restricted bands of operation.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Intentional Radiators § 15.205 Restricted bands of operation. (a) Except as shown in paragraph (d) of this... radiator. (d) The following devices are exempt from the requirements of this section: (1) Swept frequency...

  5. 47 CFR 15.103 - Exempted devices.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... exclusively as an electronic control or power system utilized by a public utility or in an industrial plant... circuit to convert the signal to the format required (e.g., an integrated circuit for analog to digital...

  6. 47 CFR 15.103 - Exempted devices.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... exclusively as an electronic control or power system utilized by a public utility or in an industrial plant... circuit to convert the signal to the format required (e.g., an integrated circuit for analog to digital...

  7. 47 CFR 15.103 - Exempted devices.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... exclusively as an electronic control or power system utilized by a public utility or in an industrial plant... circuit to convert the signal to the format required (e.g., an integrated circuit for analog to digital...

  8. 47 CFR 15.103 - Exempted devices.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... exclusively as an electronic control or power system utilized by a public utility or in an industrial plant... circuit to convert the signal to the format required (e.g., an integrated circuit for analog to digital...

  9. 47 CFR 15.103 - Exempted devices.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... exclusively as an electronic control or power system utilized by a public utility or in an industrial plant... circuit to convert the signal to the format required (e.g., an integrated circuit for analog to digital...

  10. 77 FR 51104 - Parts and Accessories Necessary for Safe Operation; Application for an Exemption From...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-23

    ... vehicles (CMVs). The Federal Motor Carrier Safety Regulations (FMCSRs) currently require antennas... the driver's field of view by devices mounted at the top of the windshield. Antennas, transponders and...

  11. 21 CFR 872.3910 - Backing and facing for an artificial tooth.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... use in fabrication of a fixed or removable dental appliance, such as a crown or bridge. The backing... is made of porcelain or plastic. (b) Classification. Class I (general controls). The device is exempt...

  12. 78 FR 4190 - Petition for Exemption; Summary of Petition Received

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-18

    ... Lines' 737-800 fleet, a placard was placed on the flight deck prohibiting use of WiFi devices from the... using the existing aircraft WiFi connection during the operational demonstration period of the research...

  13. Early clinical results of a high-flexion, posterior-stabilized, mobile-bearing total knee arthroplasty: a US investigational device exemption trial.

    PubMed

    Scuderi, Giles R; Hedden, David R; Maltry, John A; Traina, Steven M; Sheinkop, Mitchell B; Hartzband, Mark A

    2012-03-01

    Between May 2001 and June 2004, 388 total knee arthroplasty cases were enrolled in a prospective, randomized, multicenter investigational device exemption trial. Patients received either the investigational high-flexion mobile-bearing knee or a fixed-bearing control. At 2 to 4 years of follow-up, results in 293 patients with degenerative joint disease were compared using Knee Society Assessment and Function scores, radiographic results, complications analysis, and survival estimates. The mobile-bearing and fixed-bearing groups demonstrated similar, significant improvement over preoperative assessments in Knee Scores, maximum flexion, and range of motion. One mobile-bearing arthroplasty required revision. Radiographic results were unremarkable, and implant-related complications were rare in both groups. At this early follow-up, the investigational high-flexion mobile-bearing knee and its fixed-bearing counterpart demonstrated comparable, effective performance. Copyright © 2012 Elsevier Inc. All rights reserved.

  14. 76 FR 76166 - Draft Guidance for Industry and Food and Drug Administration Staff; the Content of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-06

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and FDA Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.'' This draft guidance document provides industry and the Agency staff with guidelines for developing premarket submissions for artificial pancreas device systems, in particular, the Control-to-Range (CTR) and Control-to-Target (CTT) device systems. This draft guidance is not final nor is it in effect at this time.

  15. Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.

    PubMed

    1994-06-17

    The Food and Drug Administration (FDA) is amending the regulations for delegations of authority relating to general redelegations of authority from the Associate Commissioner of Regulatory Affairs to certain FDA officials in the Center for Devices and Radiological Health (CDRH). The redelegation provides these officials with authority to grant or deny certain citizen petitions for exemption or variance from medical device tracking requirements. This action is being taken to facilitate expeditious handling of citizen petitions. FDA is also issuing a conforming amendment to the medical device tracking regulations to make the regulations consistent.

  16. 40 CFR 266.109 - Low risk waste exemption.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... of fuel fired to the device shall be fossil fuel, fuels derived from fossil fuel, tall oil, or, if... comparable to fossil fuel. Such fuels are termed “primary fuel” for purposes of this section. (Tall oil is a...

  17. 40 CFR 266.109 - Low risk waste exemption.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... of fuel fired to the device shall be fossil fuel, fuels derived from fossil fuel, tall oil, or, if... comparable to fossil fuel. Such fuels are termed “primary fuel” for purposes of this section. (Tall oil is a...

  18. 40 CFR 266.109 - Low risk waste exemption.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... of fuel fired to the device shall be fossil fuel, fuels derived from fossil fuel, tall oil, or, if... comparable to fossil fuel. Such fuels are termed “primary fuel” for purposes of this section. (Tall oil is a...

  19. 40 CFR 266.109 - Low risk waste exemption.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... of fuel fired to the device shall be fossil fuel, fuels derived from fossil fuel, tall oil, or, if... comparable to fossil fuel. Such fuels are termed “primary fuel” for purposes of this section. (Tall oil is a...

  20. 40 CFR 266.109 - Low risk waste exemption.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... of fuel fired to the device shall be fossil fuel, fuels derived from fossil fuel, tall oil, or, if... comparable to fossil fuel. Such fuels are termed “primary fuel” for purposes of this section. (Tall oil is a...

  1. 76 FR 36542 - Draft Guidance for Industry and Food and Drug Administration Staff: The Content of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled ``Draft Guidance for Industry and Food and Drug Administration Staff: The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS) Device Systems.'' This draft guidance document provides industry and Agency staff with recommendations that are intended to improve the safety and effectiveness of LGS Device Systems. This draft guidance is not final nor is it in effect at this time.

  2. 21 CFR 880.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) The modified device operates using a different fundamental scientific technology than a legally...) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For...

  3. 21 CFR 878.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) The modified device operates using a different fundamental scientific technology than a legally...) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For...

  4. 21 CFR 866.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) The modified device operates using a different fundamental scientific technology than a legally...) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For...

  5. 21 CFR 876.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) The modified device operates using a different fundamental scientific technology than a legally...) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For...

  6. 21 CFR 864.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) The modified device operates using a different fundamental scientific technology than a legally...) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For...

  7. 21 CFR 884.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) The modified device operates using a different fundamental scientific technology than a legally...) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6) For...

  8. The Employee Polygraph Protection Act of 1988.

    ERIC Educational Resources Information Center

    Duffy, Patrick J.

    1989-01-01

    Aspects of the new Employee Polygraph Protection Act are discussed, including exemptions, prohibited devices, limitations, exceptions, injury and access requirements, reasonable suspicion, drug industry investigations, procedural requirements, disclosure, basis for discharge, enforcement and remedies, and preemption and existing state laws. (MSE)

  9. 77 FR 62218 - Pacific Fishery Management Council; Public Meetings

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-12

    ... Management 1. NMFS Report 2. Exempted Fishing Permit (EFP) Process 3. Pacific Sardine Stock Assessment and... Groundfish Management Process) 3. Progress Report on Using Descending Devices to Mitigate Barotrauma in... Fishery Management Council; Public Meetings AGENCY: National Marine Fisheries Service (NMFS), National...

  10. 77 FR 65769 - Petition for Exemption From the Vehicle Theft Prevention Standard; Volkswagen Group of America, Inc.

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-30

    ... process. Key components of the antitheft device will include a passive immobilizer, a warning message... feature as standard equipment. When the system is activated, the alarm will trigger if one of the doors...

  11. 21 CFR 862.9 - Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... professionals only; (b) The modified device operates using a different fundamental scientific technology than a... therapy; (4) For assessing the risk of cardiovascular diseases; (5) For use in diabetes management; (6...

  12. 16 CFR § 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    .... (9) Lead oxide in the glass envelope of Black Light Blue (BLB) lamps. (e) Components of electronic devices that are removable or replaceable, such as battery packs and light bulbs that are inaccessible...

  13. 16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    .... (9) Lead oxide in the glass envelope of Black Light Blue (BLB) lamps. (e) Components of electronic devices that are removable or replaceable, such as battery packs and light bulbs that are inaccessible...

  14. 16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    .... (9) Lead oxide in the glass envelope of Black Light Blue (BLB) lamps. (e) Components of electronic devices that are removable or replaceable, such as battery packs and light bulbs that are inaccessible...

  15. 16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    .... (9) Lead oxide in the glass envelope of Black Light Blue (BLB) lamps. (e) Components of electronic devices that are removable or replaceable, such as battery packs and light bulbs that are inaccessible...

  16. 21 CFR 73.3124 - Phthalocyanine green.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Phthalocyanine green. 73.3124 Section 73.3124 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3124 Phthalocyanine green. (a) Identity...

  17. 21 CFR 73.3124 - Phthalocyanine green.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Phthalocyanine green. 73.3124 Section 73.3124 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3124 Phthalocyanine green. (a) Identity...

  18. 21 CFR 73.3124 - Phthalocyanine green.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Phthalocyanine green. 73.3124 Section 73.3124 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3124 Phthalocyanine green. (a) Identity...

  19. 21 CFR 808.88 - Pennsylvania.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Pennsylvania. 808.88 Section 808.88 Food and Drugs... and Local Exemptions § 808.88 Pennsylvania. (a) The following Pennsylvania medical device requirements... the condition that, in enforcing this requirement, Pennsylvania apply the definition of “used hearing...

  20. 21 CFR 809.4 - Confidentiality of submitted information.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) MEDICAL DEVICES IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE General Provisions § 809.4... within the exemption established in § 20.61 of this chapter shall be treated as confidential by the Food... Drug Administration will determine whether information submitted will be treated as confidential in...

  1. 21 CFR 809.4 - Confidentiality of submitted information.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) MEDICAL DEVICES IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE General Provisions § 809.4... within the exemption established in § 20.61 of this chapter shall be treated as confidential by the Food... Drug Administration will determine whether information submitted will be treated as confidential in...

  2. 21 CFR 866.5735 - Prothrombin immunological test system.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... factor II) in serum. Measurements of the amount of antigenically competent (ability to react with protein antibodies) prothrombin aid in the diagnosis of blood-clotting disorders. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part...

  3. 21 CFR 880.6890 - General purpose disinfectants.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false General purpose disinfectants. 880.6890 Section 880.6890 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... topical contact with intact skin. (b) Classification. Class I (general controls). The device is exempt...

  4. 21 CFR 876.1075 - Gastroenterology-urology biopsy instrument.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This... regulations. (b) Classification. (1) Class II (performance standards). (2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from...

  5. 21 CFR 876.1075 - Gastroenterology-urology biopsy instrument.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This... regulations. (b) Classification. (1) Class II (performance standards). (2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from...

  6. 21 CFR 876.1075 - Gastroenterology-urology biopsy instrument.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This... regulations. (b) Classification. (1) Class II (performance standards). (2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from...

  7. 21 CFR 812.140 - Records.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Records. 812.140 Section 812.140 Food and Drugs... INVESTIGATIONAL DEVICE EXEMPTIONS Records and Reports § 812.140 Records. (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator...

  8. 21 CFR 812.140 - Records.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Records. 812.140 Section 812.140 Food and Drugs... INVESTIGATIONAL DEVICE EXEMPTIONS Records and Reports § 812.140 Records. (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator...

  9. 21 CFR 812.140 - Records.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Records. 812.140 Section 812.140 Food and Drugs... INVESTIGATIONAL DEVICE EXEMPTIONS Records and Reports § 812.140 Records. (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator...

  10. 75 FR 30103 - Petition for Exemption From the Vehicle Theft Prevention Standard; Ford Motor Company

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-28

    ... (BCM), the PEP/RFA module and the PCM. Ford pointed out that in addition to the programmed key, the... concludes that the device will provide four of the five types of performance listed in Sec. 543.6(a)(3...

  11. 21 CFR 812.150 - Reports.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Reports. 812.150 Section 812.150 Food and Drugs... INVESTIGATIONAL DEVICE EXEMPTIONS Records and Reports § 812.150 Reports. (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: (1) Unanticipated adverse...

  12. 21 CFR 812.150 - Reports.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Reports. 812.150 Section 812.150 Food and Drugs... INVESTIGATIONAL DEVICE EXEMPTIONS Records and Reports § 812.150 Reports. (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports: (1) Unanticipated adverse...

  13. 76 FR 80948 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ...The Food and Drug Administration (FDA) is extending the comment period for the notice that appeared in the Federal Register of Thursday, November, 10, 2011 (76 FR 70151). In the notice, FDA requested comments on the draft guidance that has been developed to promote the initiation of clinical investigations to evaluate the medical devices under FDA's Investigational Device Exemptions (IDE) regulations. The Agency is taking this action to allow interested persons additional time to submit comments.

  14. Innovations in design and technology. The story of hip arthroplasty.

    PubMed

    Amstutz, H C

    2000-09-01

    The current study reviews the early history of surgeon-initiated trial and error development in hip joint arthroplasty and the subsequent methodological evolution to proper criteria for hypothesis testing using bioengineers and other research scientists. The interplay and relationships to industry, universities, scientific organizations, and the Food and Drug Administration with respect to device development in hip arthroplasty are reviewed. The ethics of and responsibilities to involved parties are outlined, citing the history of many contemporary developments. Examples are provided from the evolution and introduction of unsuccessful innovations, and the problems inherent in the current methodology of the approval process from the Food and Drug Administration using the 5-10K, Investigative Device Exemption, and the Pre-Market Approval protocols. The pros and cons of randomized trials for devices are outlined with the conclusion that they are not appropriate for device introduction. The proper, rational methodology for introduction of new devices is a phased-in clinical trial process after pertinent bench testing. Finally, the ethical dilemmas created by managed care are addressed. Industry involvements of the surgeon-spokesmen are cited.

  15. 21 CFR 808.73 - Minnesota.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Minnesota. 808.73 Section 808.73 Food and Drugs... and Local Exemptions § 808.73 Minnesota. The following Minnesota medical device requirements are... from preemption under section 521(b) of the act: Minnesota Statutes, sections 145.43 and 145.44. [45 FR...

  16. 21 CFR 808.73 - Minnesota.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Minnesota. 808.73 Section 808.73 Food and Drugs... and Local Exemptions § 808.73 Minnesota. The following Minnesota medical device requirements are... from preemption under section 521(b) of the act: Minnesota Statutes, sections 145.43 and 145.44. [45 FR...

  17. 21 CFR 808.73 - Minnesota.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Minnesota. 808.73 Section 808.73 Food and Drugs... and Local Exemptions § 808.73 Minnesota. The following Minnesota medical device requirements are... from preemption under section 521(b) of the act: Minnesota Statutes, sections 145.43 and 145.44. [45 FR...

  18. 21 CFR 808.73 - Minnesota.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Minnesota. 808.73 Section 808.73 Food and Drugs... and Local Exemptions § 808.73 Minnesota. The following Minnesota medical device requirements are... from preemption under section 521(b) of the act: Minnesota Statutes, sections 145.43 and 145.44. [45 FR...

  19. 21 CFR 808.73 - Minnesota.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Minnesota. 808.73 Section 808.73 Food and Drugs... and Local Exemptions § 808.73 Minnesota. The following Minnesota medical device requirements are... from preemption under section 521(b) of the act: Minnesota Statutes, sections 145.43 and 145.44. [45 FR...

  20. 21 CFR 73.3128 - Mica-based pearlescent pigments.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Mica-based pearlescent pigments. 73.3128 Section 73.3128 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3128 Mica-based pearlescent...

  1. 21 CFR 73.3107 - Carbazole violet.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Carbazole violet. 73.3107 Section 73.3107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3107 Carbazole violet. (a) Identity. The color...

  2. 21 CFR 73.3111 - Chromium oxide greens.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Chromium oxide greens. 73.3111 Section 73.3111 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3111 Chromium oxide greens. (a) Identity...

  3. 21 CFR 73.3121 - Poly(hydroxyethyl methacrylate)-dye copolymers.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Poly(hydroxyethyl methacrylate)-dye copolymers. 73.3121 Section 73.3121 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3121 Poly...

  4. 21 CFR 73.3111 - Chromium oxide greens.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Chromium oxide greens. 73.3111 Section 73.3111 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3111 Chromium oxide greens. (a) Identity...

  5. 21 CFR 73.3111 - Chromium oxide greens.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Chromium oxide greens. 73.3111 Section 73.3111 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3111 Chromium oxide greens. (a) Identity...

  6. 21 CFR 73.3107 - Carbazole violet.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Carbazole violet. 73.3107 Section 73.3107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3107 Carbazole violet. (a) Identity. The color...

  7. 21 CFR 73.3128 - Mica-based pearlescent pigments.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Mica-based pearlescent pigments. 73.3128 Section 73.3128 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3128 Mica-based pearlescent...

  8. 21 CFR 73.3128 - Mica-based pearlescent pigments.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Mica-based pearlescent pigments. 73.3128 Section 73.3128 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3128 Mica-based pearlescent...

  9. 21 CFR 73.3121 - Poly(hydroxyethyl methacrylate)-dye copolymers.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Poly(hydroxyethyl methacrylate)-dye copolymers. 73.3121 Section 73.3121 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3121 Poly...

  10. 21 CFR 73.3111 - Chromium oxide greens.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Chromium oxide greens. 73.3111 Section 73.3111 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3111 Chromium oxide greens. (a) Identity...

  11. 21 CFR 73.3107 - Carbazole violet.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Carbazole violet. 73.3107 Section 73.3107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3107 Carbazole violet. (a) Identity. The color...

  12. 21 CFR 73.3121 - Poly(hydroxyethyl methacrylate)-dye copolymers.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Poly(hydroxyethyl methacrylate)-dye copolymers. 73.3121 Section 73.3121 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3121 Poly...

  13. 21 CFR 73.3128 - Mica-based pearlescent pigments.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Mica-based pearlescent pigments. 73.3128 Section 73.3128 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3128 Mica-based pearlescent...

  14. 21 CFR 73.3111 - Chromium oxide greens.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Chromium oxide greens. 73.3111 Section 73.3111 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3111 Chromium oxide greens. (a) Identity...

  15. 21 CFR 73.3128 - Mica-based pearlescent pigments.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Mica-based pearlescent pigments. 73.3128 Section 73.3128 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3128 Mica-based pearlescent...

  16. 21 CFR 73.3107 - Carbazole violet.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Carbazole violet. 73.3107 Section 73.3107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3107 Carbazole violet. (a) Identity. The color...

  17. 21 CFR 73.3107 - Carbazole violet.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Carbazole violet. 73.3107 Section 73.3107 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3107 Carbazole violet. (a) Identity. The color...

  18. 21 CFR 886.4445 - Permanent magnet.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... foreign bodies from eye tissue. (b) Classification. Class I (general controls). The device is exempt from... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Permanent magnet. 886.4445 Section 886.4445 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL...

  19. 21 CFR 886.4445 - Permanent magnet.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... foreign bodies from eye tissue. (b) Classification. Class I (general controls). The device is exempt from... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Permanent magnet. 886.4445 Section 886.4445 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL...

  20. 21 CFR 886.4445 - Permanent magnet.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... foreign bodies from eye tissue. (b) Classification. Class I (general controls). The device is exempt from... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Permanent magnet. 886.4445 Section 886.4445 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL...

  1. 21 CFR 886.4445 - Permanent magnet.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... foreign bodies from eye tissue. (b) Classification. Class I (general controls). The device is exempt from... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Permanent magnet. 886.4445 Section 886.4445 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL...

  2. 27 CFR 478.145 - Research organizations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2014-04-01 2014-04-01 false Research organizations... Exemptions, Seizures, and Forfeitures § 478.145 Research organizations. The provisions of § 478.98 with...-barreled rifles shall not apply to the sale or delivery of such devices and weapons to any research...

  3. 27 CFR 478.145 - Research organizations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2010-04-01 2010-04-01 false Research organizations... Exemptions, Seizures, and Forfeitures § 478.145 Research organizations. The provisions of § 478.98 with...-barreled rifles shall not apply to the sale or delivery of such devices and weapons to any research...

  4. 27 CFR 478.145 - Research organizations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 3 2013-04-01 2013-04-01 false Research organizations... Exemptions, Seizures, and Forfeitures § 478.145 Research organizations. The provisions of § 478.98 with...-barreled rifles shall not apply to the sale or delivery of such devices and weapons to any research...

  5. 76 FR 43847 - Poison Prevention Packaging Requirements; Exemption of Powder Formulations of Colesevelam...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-22

    ... FDA-regulated drug, biologic, medical device, dietary supplement, or cosmetic. (See http://www.fda.gov... powders generally present a low risk because they are more difficult to ingest, particularly in large quantities. Generally, with the exception of caustics, the primary exposure risk associated with powders is...

  6. 21 CFR 73.3124 - Phthalocyanine green.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Phthalocyanine green. 73.3124 Section 73.3124 Food... COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3124 Phthalocyanine green. (a) Identity. The color additive is phthalocyanine green (CAS Reg. No. 1328-53-6), Colour Index No. 74260. (b) Uses...

  7. 21 CFR 73.3124 - Phthalocyanine green.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Phthalocyanine green. 73.3124 Section 73.3124 Food... COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3124 Phthalocyanine green. (a) Identity. The color additive is phthalocyanine green (CAS Reg. No. 1328-53-6), Colour Index No. 74260. (b) Uses...

  8. 21 CFR 14.27 - Determination to close portions of advisory committee meetings.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... closed if they concern review, discussion, and evaluation of general preclinical and clinical test... and devices that have previously been made public; presentation of any other information not exempt... by the following rules: (1) A portion of a meeting closed for the presentation or discussion of...

  9. 76 FR 70151 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

  10. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  11. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  12. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  13. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  14. 21 CFR 864.9600 - Potentiating media for in vitro diagnostic use.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Manufacture Blood and Blood Products § 864.9600 Potentiating media for in vitro diagnostic use. (a... to suspend red cells and to enhance cell reactions for antigen-antibody testing. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart...

  15. 21 CFR 1020.31 - Radiographic equipment.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... time, but means may be provided to permit completion of any single exposure of the series in process.... Radiation therapy simulation systems are exempt from this requirement. (iii) The edge of the light field at..., except when the spot-film device is provided for use with a radiation therapy simulation system: (1...

  16. Emergency Preservation and Resuscitation for Cardiac Arrest from Trauma (EPR CAT)

    DTIC Science & Technology

    2016-12-01

    Preservation and Resuscitation (EPR) was developed to rapidly preserve the organism during ischemia, using hypothermia, drugs , and fluids, to “ buy time...Device Exemption (IDE) from the Food and Drug Administration (FDA). Our trial is complicated by the fact that both fluids and equipment are to be used

  17. Ethical review and informed consent in cardiovascular research reports in Argentina.

    PubMed

    Borracci, Raúl A; Calderón, Gustavo; Seoane, Martín R; Perez, Analía C; Doval, Hernán C

    2008-05-01

    Requirements for Institutional Review Board approval and informed consent for research involving human subjects have existed for more than 2 decades. However, evidence of fulfillment of these requirements is sometimes lacking in cardiovascular research reports in Argentina. Since ethical standards vary between committees, there may be some confusion among researchers regarding the need for an ethical review when conducting low risk research. To examine the frequency of obtaining an ethical review and informed consent in cardiovascular research in Argentina. Through a questionnaire, we contacted authors of 100 reports submitted to our annual scientific meeting during 2006. Thirty six per cent of questionnaires were resubmitted with confirmation of ethical review, 34% responded that ethical review was not obtained, 23% reported as being exempt and 7% were never resubmitted. Most articles obtaining ethical review were pharmacological trials or research involving assessment of new devices. On the other hand, most articles reporting lack of or exemption from ethical review come from epidemiological research or studies evaluating non-invasive methods. Sixty percent of phase IV pharmacological trials, research on cellular implantation or assessment of new devices met federal regulations requirements. The rate of ethical review and use of informed consent in cardiovascular reports in Argentina vary among articles. Most research involving prospective observational studies and nearly 50% of protocols including intervention or invasive procedures do not report ethical review. This high proportion of articles lacking ethical review suggests the presence of legal and ethical flaws which should be discussed and overcome.

  18. 21 CFR 808.87 - Oregon.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Oregon. 808.87 Section 808.87 Food and Drugs FOOD... and Local Exemptions § 808.87 Oregon. (a) The following Oregon medical device requriements are... them from preemption under section 521(b) of the act: Oregon Revised Statutes, section 694.036 on the...

  19. 21 CFR 808.87 - Oregon.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Oregon. 808.87 Section 808.87 Food and Drugs FOOD... and Local Exemptions § 808.87 Oregon. (a) The following Oregon medical device requriements are... them from preemption under section 521(b) of the act: Oregon Revised Statutes, section 694.036 on the...

  20. 21 CFR 808.87 - Oregon.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Oregon. 808.87 Section 808.87 Food and Drugs FOOD... and Local Exemptions § 808.87 Oregon. (a) The following Oregon medical device requriements are... them from preemption under section 521(b) of the act: Oregon Revised Statutes, section 694.036 on the...

  1. 21 CFR 808.87 - Oregon.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Oregon. 808.87 Section 808.87 Food and Drugs FOOD... and Local Exemptions § 808.87 Oregon. (a) The following Oregon medical device requriements are... them from preemption under section 521(b) of the act: Oregon Revised Statutes, section 694.036 on the...

  2. 21 CFR 808.87 - Oregon.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false Oregon. 808.87 Section 808.87 Food and Drugs FOOD... and Local Exemptions § 808.87 Oregon. (a) The following Oregon medical device requriements are... them from preemption under section 521(b) of the act: Oregon Revised Statutes, section 694.036 on the...

  3. 21 CFR 876.5820 - Hemodialysis system and accessories.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop..., dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the...

  4. 21 CFR 73.3106 - 1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone copolymers.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false 1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone copolymers. 73.3106 Section 73.3106 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices...

  5. 21 CFR 73.3106 - 1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone copolymers.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false 1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone copolymers. 73.3106 Section 73.3106 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices...

  6. 21 CFR 73.3110a - Chromium-cobalt-aluminum oxide.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Chromium-cobalt-aluminum oxide. 73.3110a Section 73.3110a Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3110a Chromium-cobalt-aluminum...

  7. 21 CFR 73.3110a - Chromium-cobalt-aluminum oxide.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Chromium-cobalt-aluminum oxide. 73.3110a Section 73.3110a Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3110a Chromium-cobalt-aluminum...

  8. 21 CFR 73.3110a - Chromium-cobalt-aluminum oxide.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Chromium-cobalt-aluminum oxide. 73.3110a Section 73.3110a Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3110a Chromium-cobalt-aluminum...

  9. 21 CFR 73.3110a - Chromium-cobalt-aluminum oxide.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Chromium-cobalt-aluminum oxide. 73.3110a Section 73.3110a Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3110a Chromium-cobalt-aluminum...

  10. 21 CFR 73.3106 - 1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone copolymers.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false 1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone copolymers. 73.3106 Section 73.3106 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices...

  11. 21 CFR 73.3106 - 1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone copolymers.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false 1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone copolymers. 73.3106 Section 73.3106 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices...

  12. 21 CFR 73.3106 - 1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone copolymers.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false 1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone copolymers. 73.3106 Section 73.3106 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices...

  13. 21 CFR 73.3110a - Chromium-cobalt-aluminum oxide.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Chromium-cobalt-aluminum oxide. 73.3110a Section 73.3110a Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3110a Chromium-cobalt-aluminum...

  14. 21 CFR 808.81 - New Mexico.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false New Mexico. 808.81 Section 808.81 Food and Drugs... and Local Exemptions § 808.81 New Mexico. The following New Mexico medical device requirement is... from preemption under section 521(b) of the act: New Mexico Statutes Annotated, section 67-36-16(F...

  15. 77 FR 65260 - Exemption to Prohibition on Circumvention of Copyright Protection Systems for Access Control...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-26

    ... proprietary software (e.g., Amazon's Kindle) to multipurpose devices running free software applications (e.g... Media Rights, Mozilla Corporation (``Mozilla''), and the Free Software Foundation (``FSF''), as well as... radical popularity over the past two years.'' EFF asserted that courts have long found copying and...

  16. 21 CFR 801.119 - In vitro diagnostic products.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false In vitro diagnostic products. 801.119 Section 801...) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.119 In vitro diagnostic products. A product intended for use in the diagnosis of disease and which is an in vitro diagnostic...

  17. 21 CFR 801.119 - In vitro diagnostic products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false In vitro diagnostic products. 801.119 Section 801...) MEDICAL DEVICES LABELING Exemptions From Adequate Directions for Use § 801.119 In vitro diagnostic products. A product intended for use in the diagnosis of disease and which is an in vitro diagnostic...

  18. 77 FR 71030 - Petition To Modify an Exemption of a Previously Approved Antitheft Device; Mitsubishi Motors R&D...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-28

    ... encrypted start-code signal to the engine ECU to allow the driver to start the vehicle. The power train only... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration Petition To Modify an... Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT). ACTION: Grant of...

  19. 76 FR 78930 - Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    ... enforcement of premarket notification (510(k)) requirements for certain in vitro diagnostic and radiology... profiles and for which it believes 510(k) review is not necessary to assure safety and effectiveness. While FDA intends to exempt these devices from the 510(k) requirement through rulemaking that would...

  20. 21 CFR 808.81 - New Mexico.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 8 2012-04-01 2012-04-01 false New Mexico. 808.81 Section 808.81 Food and Drugs... and Local Exemptions § 808.81 New Mexico. The following New Mexico medical device requirement is... from preemption under section 521(b) of the act: New Mexico Statutes Annotated, section 67-36-16(F...

  1. 21 CFR 808.81 - New Mexico.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 8 2013-04-01 2013-04-01 false New Mexico. 808.81 Section 808.81 Food and Drugs... and Local Exemptions § 808.81 New Mexico. The following New Mexico medical device requirement is... from preemption under section 521(b) of the act: New Mexico Statutes Annotated, section 67-36-16(F...

  2. 21 CFR 808.81 - New Mexico.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false New Mexico. 808.81 Section 808.81 Food and Drugs... and Local Exemptions § 808.81 New Mexico. The following New Mexico medical device requirement is... from preemption under section 521(b) of the act: New Mexico Statutes Annotated, section 67-36-16(F...

  3. 21 CFR 808.81 - New Mexico.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 8 2011-04-01 2011-04-01 false New Mexico. 808.81 Section 808.81 Food and Drugs... and Local Exemptions § 808.81 New Mexico. The following New Mexico medical device requirement is... from preemption under section 521(b) of the act: New Mexico Statutes Annotated, section 67-36-16(F...

  4. 21 CFR 808.61 - Hawaii.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Hawaii. 808.61 Section 808.61 Food and Drugs FOOD... and Local Exemptions § 808.61 Hawaii. (a) The following Hawaii medical device requirements are... from preemption under section 521(b) of the act: Hawaii Revised Statutes, chapter 451A, § 14.1...

  5. Complications of Lumbar Artificial Disc Replacement Compared to Fusion: Results From the Prospective, Randomized, Multicenter US Food and Drug Administration Investigational Device Exemption Study of the Charité Artificial Disc

    PubMed Central

    Majd, Mohammed E.; Isaza, Jorge E.; Blumenthal, Scott L.; McAfee, Paul C.; Guyer, Richard D.; Hochschuler, Stephen H.; Geisler, Fred H.; Garcia, Rolando; Regan, John J.

    2007-01-01

    Background Previous reports of lumbar total disc replacement (TDR) have described significant complications. The US Food and Drug Administration (FDA) investigational device exemption (IDE) study of the Charité artificial disc represents the first level I data comparison of TDR to fusion. Methods In the prospective, randomized, multicenter IDE study, patients were randomized in a 2:1 ratio, with 205 patients in the Charité group and 99 patients in the control group (anterior lumbar interbody fusion [ALIF] with BAK cages). Inclusion criteria included confirmed single-level degenerative disc disease at L4-5 or L5-S1 and failure of nonoperative treatment for at least 6 months. Complications were reported throughout the study. Results The rate of approach-related complications was 9.8% in the investigational group and 10.1% in the control group. The rate of major neurological complications was similar between the 2 groups (investigational = 4.4%, control = 4.0%). There was a higher rate of superficial wound infection in the investigational group but no deep wound infections in either group. Pseudarthrosis occurred in 9.1% of control group patients. The rate of subsidence in the investigational group was 3.4%. The reoperation rate was 5.4% in the investigational group and 9.1% in the control group. Conclusions The incidence of perioperative and postoperative complications for lumbar TDR was similar to that of ALIF. Vigilance is necessary with respect to patient indications, training, and correct surgical technique to maintain TDR complications at the levels experienced in the IDE study. PMID:25802575

  6. 49 CFR Appendix A-I to Part 541 - Lines With Antitheft Devices Which Are Exempted From the Parts-Marking Requirements of This...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... Tribeca. Outback. Suzuki XL-7. Toyota Camry.1 Lexus ES. Lexus GS. Lexus LS. Lexus SC. Volkswagen Audi 5000S. Audi A3. Audi A4. Audi Allroad. Audi A6. Audi Q5. New Beetle. Golf/Rabbit/GTI/R32. Jetta. Passat...

  7. 21 CFR 73.3105 - 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione. 73.3105 Section 73.3105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3105 1...

  8. 21 CFR 73.3112 - C.I. Vat Orange 1.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false C.I. Vat Orange 1. 73.3112 Section 73.3112 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3112 C.I. Vat Orange 1. (a) Identity. The...

  9. 21 CFR 73.3112 - C.I. Vat Orange 1.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false C.I. Vat Orange 1. 73.3112 Section 73.3112 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3112 C.I. Vat Orange 1. (a) Identity. The...

  10. 21 CFR 73.3105 - 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione. 73.3105 Section 73.3105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3105 1...

  11. 21 CFR 73.3112 - C.I. Vat Orange 1.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false C.I. Vat Orange 1. 73.3112 Section 73.3112 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3112 C.I. Vat Orange 1. (a) Identity. The...

  12. 21 CFR 73.3105 - 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione. 73.3105 Section 73.3105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3105 1...

  13. 21 CFR 73.3112 - C.I. Vat Orange 1.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false C.I. Vat Orange 1. 73.3112 Section 73.3112 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3112 C.I. Vat Orange 1. (a) Identity. The...

  14. 21 CFR 73.3112 - C.I. Vat Orange 1.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false C.I. Vat Orange 1. 73.3112 Section 73.3112 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3112 C.I. Vat Orange 1. (a) Identity. The...

  15. 21 CFR 73.3105 - 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione. 73.3105 Section 73.3105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3105 1...

  16. 21 CFR 73.3105 - 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione. 73.3105 Section 73.3105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3105 1...

  17. 33 CFR 150.915 - How are safety zones, no anchoring areas, and areas to be avoided established and modified?

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... local conditions of geography, climate and other similar factors; (4) The need for granting exemptions for the installation and use of equipment or devices for use with vessel traffic services for certain... proximity of fishing grounds, oil and gas drilling and production operations, or other potential or actual...

  18. 33 CFR 150.915 - How are safety zones, no anchoring areas, and areas to be avoided established and modified?

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... local conditions of geography, climate and other similar factors; (4) The need for granting exemptions for the installation and use of equipment or devices for use with vessel traffic services for certain... proximity of fishing grounds, oil and gas drilling and production operations, or other potential or actual...

  19. 33 CFR 150.915 - How are safety zones, no anchoring areas, and areas to be avoided established and modified?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... local conditions of geography, climate and other similar factors; (4) The need for granting exemptions for the installation and use of equipment or devices for use with vessel traffic services for certain... proximity of fishing grounds, oil and gas drilling and production operations, or other potential or actual...

  20. 33 CFR 150.915 - How are safety zones, no anchoring areas, and areas to be avoided established and modified?

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... local conditions of geography, climate and other similar factors; (4) The need for granting exemptions for the installation and use of equipment or devices for use with vessel traffic services for certain... proximity of fishing grounds, oil and gas drilling and production operations, or other potential or actual...

  1. 33 CFR 150.915 - How are safety zones, no anchoring areas, and areas to be avoided established and modified?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... local conditions of geography, climate and other similar factors; (4) The need for granting exemptions for the installation and use of equipment or devices for use with vessel traffic services for certain... proximity of fishing grounds, oil and gas drilling and production operations, or other potential or actual...

  2. 40 CFR 60.482-10a - Standards: Closed vent systems and control devices.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Performance for Equipment Leaks of VOC in the Synthetic Organic Chemicals Manufacturing Industry for Which... vent system is operated under a vacuum, it is exempt from the inspection requirements of paragraphs (f... as a consequence of complying with paragraphs (f)(1)(i) or (f)(2) of this section; and (2) The owner...

  3. 75 FR 32951 - Determination of Regulatory Review Period for Purposes of Patent Extension; PROMACTA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ... Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term... years so long as the patented item (human drug product, animal drug product, medical device, food... and an approval phase. For human drug products, the testing phase begins when the exemption to permit...

  4. 77 FR 34388 - Determination of Regulatory Review Period for Purposes of Patent Extension; CYSVIEW (Previously...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-11

    ... Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L... patented item (human drug product, animal drug product, medical device, food additive, or color additive... drug products, the testing phase begins when the exemption to permit the clinical investigations of the...

  5. 75 FR 17414 - Determination of Regulatory Review Period for Purposes of Patent Extension; TOVIAZ

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act... as the patented item (human drug product, animal drug product, medical device, food additive, or... approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical...

  6. 76 FR 36548 - Determination of Regulatory Review Period for Purposes of Patent Extension; METVIXIA

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-22

    ... 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670... (human drug product, animal drug product, medical device, food additive, or color additive) was subject... drug products, the testing phase begins when the exemption to permit the clinical investigations of the...

  7. 75 FR 18213 - Determination of Regulatory Review Period for Purposes of Patent Extension; MOZOBIL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-09

    ... Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act... as the patented item (human drug product, animal drug product, medical device, food additive, or... approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical...

  8. 75 FR 19406 - Determination of Regulatory Review Period for Purposes of Patent Extension; AFINITOR

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-14

    ... Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act... as the patented item (human drug product, animal drug product, medical device, food additive, or... approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical...

  9. 76 FR 36929 - Determination of Regulatory Review Period for Purposes of Patent Extension; DEXILANT

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-23

    ... Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L... patented item (human drug product, animal drug product, medical device, food additive, or color additive... drug products, the testing phase begins when the exemption to permit the clinical investigations of the...

  10. 75 FR 9227 - Determination of Regulatory Review Period for Purposes of Patent Extension; FIRMAGON

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-01

    ... Patent Term Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term... years so long as the patented item (human drug product, animal drug product, medical device, food... and an approval phase. For human drug products, the testing phase begins when the exemption to permit...

  11. 75 FR 17415 - Determination of Regulatory Review Period for Purposes of Patent Extension; FANAPT

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug and Patent Term Restoration Act... as the patented item (human drug product, animal drug product, medical device, food additive, or... approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical...

  12. From discard ban to exemption: How can gear technology help reduce catches of undersized Nephrops and hake in the Bay of Biscay trawling fleet?

    PubMed

    Vogel, Camille; Kopp, Dorothée; Méhault, Sonia

    2017-01-15

    On January 1st, 2016, the French mixed Nephrops and hake fishery of the Grande Vasière, an area located in the Bay of Biscay, fell under the discard ban implemented as part of the new European Common Fisheries Policy. The fleet records historically high levels of discard despite numerous gear selectivity studies. Together with high discards survival, new technological solutions to minimize catches of undersized individuals could justify local exemptions from the discard ban. Our study focuses on the effects of two selective devices, a square mesh cylinder (SMC) and a grid, on the escapement of undersized individuals and discard reduction. Relative catch probability of the modified gear compared with the traditional gear was modelled using the catch comparison method. Potential losses from the commercial fraction of the catch were taken into account to assess their influence on the economic viability of fishing with the modified gears. The two devices had similar effects on undersized Nephrops escapement and on discard reduction, with median values of 26.5% and 23.6% for the SMC and of 30.4% and 21.4% for the grid, respectively. Only the grid was efficient for undersized hake, recording median values of escapement and discard reduction equal to 25.0% and 20.6%, respectively. Some loss from the commercial fraction of the catch was to be expected with both devices, which could be compensated for in the long term by the contribution of undersized individuals to the stock biomass. Our results support the use of selective gears technology as part of an integrated framework including control and management measures to mitigate the effect of the discard ban both for fishers and for the ecosystem. Further work is needed to quantify the effect of additional escapement from the gear on stock dynamics. Copyright © 2016 Elsevier Ltd. All rights reserved.

  13. Very late complications of cervical arthroplasty: results of 2 controlled randomized prospective studies from a single investigator site.

    PubMed

    Hacker, Francis M; Babcock, Rebecca M; Hacker, Robert J

    2013-12-15

    Prospective, single-site, randomized, Food and Drug Administration-approved investigational device exemption clinical trials of 2 cervical arthroplasty (CA) devices. To evaluate complications with CA occurring more than 4 years after the surgical procedure in Food and Drug Administration clinical trials of the Bryan and Prestige LP arthroplasty devices. Reports of several randomized clinical studies have shown CA to be a safe and effective alternative to anterior cervical fusion in the treatment of degenerative cervical disc disorders. A majority include follow-up intervals of 4 years or less. Between 2002 and 2006, 94 patients were enrolled in Food and Drug Administration studies of the Bryan and Prestige LP cervical disc devices. Charts, imaging studies, and hospital records were reviewed for those who underwent arthroplasty and returned more than 4 years after their surgical procedure with neck-related pain or dysfunction. Excluding adjacent segment disease that occurred with a similar rate for patients who underwent fusion and arthroplasty, 5 patients, all treated with arthroplasty, returned for evaluation of neck and arm symptoms between 48 and 72 months after surgery. Four patients had peridevice vertebral body bone loss. One patient had posterior device migration and presented with myelopathy. Three required revision surgery and 2 were observed. Four patients maintained follow-up and reported stabilization or improvement in symptoms. Despite their similarities, CA and fusion are not equivalent procedures in this study in regard to very late complications. Similar to large joint arthroplasty, delayed device-related complications may occur with CA. These complications commenced well beyond the time frame for complications associated with more traditional cervical spine procedures. Both patients and surgeons should be aware of the potential for very late device-related complications occurring with CA and the need for revision surgery. 1.

  14. A prospective trial for laparoscopic adjustable gastric banding in morbidly obese adolescents: an interim report of weight loss, metabolic and quality of life outcomes.

    USDA-ARS?s Scientific Manuscript database

    The outcome of patients completing 12 months of follow-up in a prospective longitudinal trial of the safety/efficacy of laparoscopic adjustable gastric banding (LAGB), for morbidly obese adolescents aged 14 to 17 years using a Food and Drug Administration Institutional Device Exemption for the use o...

  15. 21 CFR 73.3119 - 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone. 73.3119 Section 73.3119 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3119 7...

  16. 21 CFR 73.3119 - 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone. 73.3119 Section 73.3119 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3119 7...

  17. 21 CFR 73.3119 - 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone. 73.3119 Section 73.3119 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3119 7...

  18. 21 CFR 73.3119 - 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone. 73.3119 Section 73.3119 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3119 7...

  19. 21 CFR 73.3119 - 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 1 2011-04-01 2011-04-01 false 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone. 73.3119 Section 73.3119 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION Medical Devices § 73.3119 7...

  20. 78 FR 21189 - Petition for Exemption From the Vehicle Theft Prevention Standard; BMW of North America, LLC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-09

    ... must be recognized by the EWS/CAS control unit in order for the vehicle to start. The transponder... in the mechanical keys make the locks almost impossible to pick and the keys impossible to duplicate... description of the antitheft device is necessary in order to notify law enforcement agencies of new vehicle...

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