Sample records for device exemption hde
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Humanitarian Use Device and Humanitarian Device Exemption regulatory programs: pros and cons.
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.
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A decade of emerging indications: deep brain stimulation in the United States.
Youngerman, Brett E; Chan, Andrew K; Mikell, Charles B; McKhann, Guy M; Sheth, Sameer A
2016-08-01
OBJECTIVE Deep brain stimulation (DBS) is an emerging treatment option for an expanding set of neurological and psychiatric diseases. Despite growing enthusiasm, the patterns and implications of this rapid adoption are largely unknown. National trends in DBS surgery performed for all indications between 2002 and 2011 are reported. METHODS Using a national database of hospital discharges, admissions for DBS for 14 indications were identified and categorized as either FDA approved, humanitarian device exempt (HDE), or emerging. Trends over time were examined, differences were analyzed by univariate analyses, and outcomes were analyzed by hierarchical regression analyses. RESULTS Between 2002 and 2011, there were an estimated 30,490 discharges following DBS for approved indications, 1647 for HDE indications, and 2014 for emerging indications. The volume for HDE and emerging indications grew at 36.1% annually in comparison with 7.0% for approved indications. DBS for emerging indications occurred at hospitals with more neurosurgeons and neurologists locally, but not necessarily at those with the highest DBS caseloads. Patients treated for HDE and emerging indications were younger with lower comorbidity scores. HDE and emerging indications were associated with greater rates of reported complications, longer lengths of stay, and greater total costs. CONCLUSIONS DBS for HDE and emerging indications underwent rapid growth in the last decade, and it is not exclusively the most experienced DBS practitioners leading the charge to treat the newest indications. Surgeons may be selecting younger and healthier patients for their early experiences. Differences in reported complication rates warrant further attention and additional costs should be anticipated as surgeons gain experience with new patient populations and targets.
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Solubilization of protein aggregates by the acid stress chaperones HdeA and HdeB.
Malki, Abderrahim; Le, Hai-Tuong; Milles, Sigrid; Kern, Renée; Caldas, Teresa; Abdallah, Jad; Richarme, Gilbert
2008-05-16
The acid stress chaperones HdeA and HdeB of Escherichia coli prevent the aggregation of periplasmic proteins at acidic pH. We show in this report that they also form mixed aggregates with proteins that have failed to be solubilized at acidic pH and allow their subsequent solubilization at neutral pH. HdeA, HdeB, and HdeA and HdeB together display an increasing efficiency for the solubilization of protein aggregates at pH 3. They are less efficient for the solubilization of aggregates at pH 2, whereas HdeB is the most efficient. Increasing amounts of periplasmic proteins draw increasing amounts of chaperone into pellets, suggesting that chaperones co-aggregate with their substrate proteins. We observed a decrease in the size of protein aggregates in the presence of HdeA and HdeB, from very high molecular mass aggregates to 100-5000-kDa species. Moreover, a marked decrease in the exposed hydrophobicity of aggregated proteins in the presence of HdeA and HdeB was revealed by 1,1'-bis(4-anilino)naphtalene-5,5'-disulfonic acid binding experiments. In vivo, during the recovery at neutral pH of acid stressed bacterial cells, HdeA and HdeB allow the solubilization and renaturation of protein aggregates, including those formed by the maltose receptor MalE, the oligopeptide receptor OppA, and the histidine receptor HisJ. Thus, HdeA and HdeB not only help to maintain proteins in a soluble state during acid treatment, as previously reported, but also assist, both in vitro and in vivo, in the solubilization at neutral pH of mixed protein-chaperone aggregates formed at acidic pH, by decreasing the size of protein aggregates and the exposed hydrophobicity of aggregated proteins.
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Louie, Jacqueline W.; Fagerquist, Clifton K.; Sultan, Omar; Miller, William G.; Mandrell, Robert E.
2012-01-01
The periplasmic chaperones HdeA and HdeB are known to be important for cell survival at low pH (pH < 3) in Escherichia coli and Shigella spp. Here we investigated the roles of HdeA and HdeB in the survival of various enterohemorrhagic E. coli (EHEC) following exposure to pH 2.0. Similar to K-12 strains, the acid protections conferred by HdeA and HdeB in EHEC O145 were significant: loss of HdeA and HdeB led to over 100- to 1,000-fold reductions in acid survival, depending on the growth condition of prechallenge cells. However, this protection was much less in E. coli O157:H7 strains. Deletion of hdeB did not affect the acid survival of cells, and deletion of hdeA led to less than a 5-fold decrease in survival. Sequence analysis of the hdeAB operon revealed a point mutation at the putative start codon of the hdeB gene in all 26 E. coli O157:H7 strains analyzed, which shifted the ATG start codon to ATA. This mutation correlated with the lack of HdeB in E. coli O157:H7; however, the plasmid-borne O157-hdeB was able to restore partially the acid resistance in an E. coli O145ΔhdeAB mutant, suggesting the potential function of O157-HdeB as an acid chaperone. We conclude that E. coli O157:H7 strains have evolved acid survival strategies independent of the HdeA/B chaperones and are more acid resistant than nonpathogenic K-12 for cells grown under nonfavorable culturing conditions such as in Luria-Bertani no-salt broth at 28°C. These results suggest a divergent evolution of acid resistance mechanisms within E. coli. PMID:22179243
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21 CFR 814.100 - Purpose and scope.
Code of Federal Regulations, 2014 CFR
2014-04-01
... concerning: (1) Any pediatric subpopulations (neonates, infants, children, adolescents) that suffer from the... of Orphan Products Development, and (2) Submitting an HDE to the Office of Device Evaluation (ODE...
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Socher, Eileen; Sticht, Heinrich
2016-11-23
HdeA and YmgD are structurally homologous proteins in the periplasm of Escherichia coli. HdeA has been shown to represent an acid-activated chaperone, whereas the function of YmgD has not yet been characterized. We performed pH-titrating molecular dynamics simulations (pHtMD) to investigate the structural changes of both proteins and to assess whether YmgD may also exhibit an unfolding behavior similar to that of HdeA. The unfolding pathway of HdeA includes partially unfolded dimer structures, which represent a prerequisite for subsequent dissociation. In contrast to the coupled unfolding and dissociation of HdeA, YmgD displays dissociation of the folded subunits, and the subunits do not undergo significant unfolding even at low pH values. The differences in subunit stability between HdeA and YmgD may be explained by the structural features of helix D, which represents the starting point of unfolding in HdeA. In summary, the present study suggests that YmgD either is not an acid-activated chaperone or, at least, does not require unfolding for activation.
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Diagnosing ΛHDE model with statefinder hierarchy and fractional growth parameter
NASA Astrophysics Data System (ADS)
Zhou, LanJun; Wang, Shuang
2016-07-01
Recently, a new dark energy model called ΛHDE was proposed. In this model, dark energy consists of two parts: cosmological constant Λ and holographic dark energy (HDE). Two key parameters of this model are the fractional density of cosmological constant ΩΛ0, and the dimensionless HDE parameter c. Since these two parameters determine the dynamical properties of DE and the destiny of universe, it is important to study the impacts of different values of ΩΛ0 and c on the ΛHDE model. In this paper, we apply various DE diagnostic tools to diagnose ΛHDE models with different values of ΩΛ0 and c; these tools include statefinder hierarchy {S 3 (1) , S 4 (1) }, fractional growth parameter ɛ, and composite null diagnostic (CND), which is a combination of {S 3 (1) , S 4 (1) } and ɛ. We find that: (1) adopting different values of ΩΛ0 only has quantitative impacts on the evolution of the ΛHDE model, while adopting different c has qualitative impacts; (2) compared with S 3 (1) , S 4 (1) can give larger differences among the cosmic evolutions of the ΛHDE model associated with different ΩΛ0 or different c; (3) compared with the case of using a single diagnostic, adopting a CND pair has much stronger ability to diagnose the ΛHDE model.
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HdeB chaperone activity is coupled to its intrinsic dynamic properties
Ding, Jienv; Yang, Chengfeng; Niu, Xiaogang; Hu, Yunfei; Jin, Changwen
2015-01-01
Enteric bacteria encounter extreme acidity when passing through hosts’ stomach. Since the bacterial periplasmic space quickly equilibrates with outer environment, an efficient acid resistance mechanism is essential in preventing irreversible protein denaturation/aggregation and maintaining bacteria viability. HdeB, along with its homolog HdeA, was identified as a periplasmic acid-resistant chaperone. Both proteins exist as homodimers and share similar monomeric structures under neutral pH, while showing different dimeric packing interfaces. Previous investigations show that HdeA functions through an acid-induced dimer-to-monomer transition and partial unfolding at low pH (pH 2–3), resulting in exposure of hydrophobic surfaces that bind substrate proteins. In contrast, HdeB appears to have a much higher optimal activation pH (pH 4–5), under which condition the protein maintains a well-folded dimer and the mechanism for its chaperone activity remains elusive. Herein, we present an NMR study of HdeB to investigate its dynamic properties. Our results reveal that HdeB undergoes significant micro- to milli-second timescale conformational exchanges at neutral to near-neutral pH, under the later condition it exhibits optimal activity. The current study indicates that HdeB activation is coupled to its intrinsic dynamics instead of structural changes, and therefore its functional mechanism is apparently different from HdeA. PMID:26593705
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Proteases in agricultural dust induce lung inflammation through PAR-1 and PAR-2 activation.
Romberger, Debra J; Heires, Art J; Nordgren, Tara M; Souder, Chelsea P; West, William; Liu, Xiang-de; Poole, Jill A; Toews, Myron L; Wyatt, Todd A
2015-08-15
Workers exposed to aerosolized dust present in concentrated animal feeding operations (CAFOs) are susceptible to inflammatory lung diseases, such as chronic obstructive pulmonary disease. Extracts of dust collected from hog CAFOs [hog dust extract (HDE)] are potent stimulators of lung inflammatory responses in several model systems. The observation that HDE contains active proteases prompted the present study, which evaluated the role of CAFO dust proteases in lung inflammatory processes and tested whether protease-activated receptors (PARs) are involved in the signaling pathway for these events. We hypothesized that the damaging proinflammatory effect of HDE is due, in part, to the proteolytic activation of PARs, and inhibiting the proteases in HDE or disrupting PAR activation would attenuate HDE-mediated inflammatory indexes in bronchial epithelial cells (BECs), in mouse lung slices in vitro, and in a murine in vivo exposure model. Human BECs and mouse lung slice cultures stimulated with 5% HDE released significantly more of each of the cytokines measured (IL-6, IL-8, TNF-α, keratinocyte-derived chemokine/CXC chemokine ligand 1, and macrophage inflammatory protein-2/CXC chemokine ligand 2) than controls, and these effects were markedly diminished by protease inhibition. Inhibition of PARs also blunted the HDE-induced cytokine release from BECs. In addition, protease depletion inhibited HDE-induced BEC intracellular PKCα and PKCε activation. C57BL/6J mice administered 12.5% HDE intranasally, either once or daily for 3 wk, exhibited increased total cellular and neutrophil influx, bronchial alveolar fluid inflammatory cytokines, lung histopathology, and inflammatory scores compared with mice receiving protease-depleted HDE. These data suggest that proteases in dust from CAFOs are important mediators of lung inflammation, and these proteases and their receptors may provide novel targets for therapeutic intervention in CAFO dust-induced airways disease.
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Holographic dark energy with cosmological constant
NASA Astrophysics Data System (ADS)
Hu, Yazhou; Li, Miao; Li, Nan; Zhang, Zhenhui
2015-08-01
Inspired by the multiverse scenario, we study a heterotic dark energy model in which there are two parts, the first being the cosmological constant and the second being the holographic dark energy, thus this model is named the ΛHDE model. By studying the ΛHDE model theoretically, we find that the parameters d and Ωhde are divided into a few domains in which the fate of the universe is quite different. We investigate dynamical behaviors of this model, and especially the future evolution of the universe. We perform fitting analysis on the cosmological parameters in the ΛHDE model by using the recent observational data. We find the model yields χ2min=426.27 when constrained by Planck+SNLS3+BAO+HST, comparable to the results of the HDE model (428.20) and the concordant ΛCDM model (431.35). At 68.3% CL, we obtain -0.07<ΩΛ0<0.68 and correspondingly 0.04<Ωhde0<0.79, implying at present there is considerable degeneracy between the holographic dark energy and cosmological constant components in the ΛHDE model.
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21 CFR 814.118 - Denial of approval or withdrawal of approval of an HDE.
Code of Federal Regulations, 2010 CFR
2010-04-01
... contains an untrue statement of material fact, or omits material information; (5) The device's labeling... in compliance with the good laboratory practice regulations in part 58 of this chapter and no reason... conducting the study and the good laboratory practice regulations do not support the validity of the study...
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Federal Register 2010, 2011, 2012, 2013, 2014
2012-12-17
... (HDE) applications and the collection of information regarding the annual distribution number (ADN... that the Secretary of Health and Human Services (the Secretary) will assign an ADN for devices that meet the eligibility criteria to be permitted to be sold for profit. The ADN is defined as the number...
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DOE Office of Scientific and Technical Information (OSTI.GOV)
Zhang, Jing-Fei; Zhao, Ming-Ming; Li, Yun-He
The model of holographic dark energy (HDE) with massive neutrinos and/or dark radiation is investigated in detail. The background and perturbation evolutions in the HDE model are calculated. We employ the PPF approach to overcome the gravity instability difficulty (perturbation divergence of dark energy) led by the equation-of-state parameter w evolving across the phantom divide w=−1 in the HDE model with c<1. We thus derive the evolutions of density perturbations of various components and metric fluctuations in the HDE model. The impacts of massive neutrino and dark radiation on the CMB anisotropy power spectrum and the matter power spectrum inmore » the HDE scenario are discussed. Furthermore, we constrain the models of HDE with massive neutrinos and/or dark radiation by using the latest measurements of expansion history and growth of structure, including the Planck CMB temperature data, the baryon acoustic oscillation data, the JLA supernova data, the Hubble constant direct measurement, the cosmic shear data of weak lensing, the Planck CMB lensing data, and the redshift space distortions data. We find that ∑ m{sub ν}<0.186 eV (95% CL) and N{sub eff}=3.75{sup +0.28}{sub −0.32} in the HDE model from the constraints of these data.« less
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NASA Astrophysics Data System (ADS)
Zhao, Ze; Wang, Shuang
2018-03-01
The main purpose of this work is to distinguish various holographic type dark energy (DE) models, including the ΛHDE, HDE, NADE, and RDE model, by using various diagnostic tools. The first diagnostic tool is the Statefinder hierarchy, in which the evolution of Statefinder hierarchy parmeter S (1) 3( z) and S (1) 4( z) are studied. The second is composite null diagnostic (CND), in which the trajectories of { S (1) 3, ɛ} and { S (1) 4, ɛ} are investigated, where ɛ is the fractional growth parameter. The last is w-w' analysis, where w is the equation of state for DE and the prime denotes derivative with respect to ln a. In the analysis we consider two cases: varying current fractional DE density Ω de0 and varying DE model parameter C. We find that: (1) both the Statefinder hierarchy and the CND have qualitative impact on ΛHDE, but only have quantitative impact on HDE. (2) S (1) 4 can lead to larger differences than S (1) 3, while the CND pair has a stronger ability to distinguish different models than the Statefinder hierarchy. (3) For the case of varying C, the { w,w'} pair has qualitative impact on ΛHDE; for the case of varying Ω de0, the { w, w'} pair only has quantitative impact; these results are different from the cases of HDE, RDE, and NADE, in which the {w,w'} pair only has quantitative impact on these models. In conclusion, compared with HDE, RDE, and NADE, the ΛHDE model can be easily distinguished by using these diagnostic tools.
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Holographic dark energy with cosmological constant
DOE Office of Scientific and Technical Information (OSTI.GOV)
Hu, Yazhou; Li, Nan; Zhang, Zhenhui
2015-08-01
Inspired by the multiverse scenario, we study a heterotic dark energy model in which there are two parts, the first being the cosmological constant and the second being the holographic dark energy, thus this model is named the ΛHDE model. By studying the ΛHDE model theoretically, we find that the parameters d and Ω{sub hde} are divided into a few domains in which the fate of the universe is quite different. We investigate dynamical behaviors of this model, and especially the future evolution of the universe. We perform fitting analysis on the cosmological parameters in the ΛHDE model by usingmore » the recent observational data. We find the model yields χ{sup 2}{sub min}=426.27 when constrained by Planck+SNLS3+BAO+HST, comparable to the results of the HDE model (428.20) and the concordant ΛCDM model (431.35). At 68.3% CL, we obtain −0.07« less
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New Holographic Chaplygin Gas Model of Dark Energy
NASA Astrophysics Data System (ADS)
Malekjani, M.; Khodam-Mohammadi, A.
In this work, we investigate the holographic dark energy model with a new infrared cutoff (new HDE model), proposed by Granda and Oliveros. Using this new definition for the infrared cutoff, we establish the correspondence between the new HDE model and the standard Chaplygin gas (SCG), generalized Chaplygin gas (GCG) and modified Chaplygin gas (MCG) scalar field models in a nonflat universe. The potential and dynamics for these scalar field models, which describe the accelerated expansion of the universe, are reconstructed. According to the evolutionary behavior of the new HDE model, we derive the same form of dynamics and potential for the different SCG, GCG and MCG models. We also calculate the squared sound speed of the new HDE model as well as the SCG, GCG and MCG models, and investigate the new HDE Chaplygin gas models from the viewpoint of linear perturbation theory. In addition, all results in the nonflat universe are discussed in the limiting case of the flat universe, i.e. k = 0.
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USDA-ARS?s Scientific Manuscript database
Periplasmic chaperones HdeA and HdeB are known to be important for cell survival at low pH (pH<3) in E. coli and Shigella spp. Here we investigated the roles of these two acid chaperones in survival of various enterohemorrhagic E. coli (EHEC) following exposure to pH 2.0. Similar to K-12 strains, th...
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Reproducibility of a novel model of murine asthma-like pulmonary inflammation
MCKINLEY, L; KIM, J; BOLGOS, G L; SIDDIQUI, J; REMICK, D G
2004-01-01
Sensitization to cockroach allergens (CRA) has been implicated as a major cause of asthma, especially among inner-city populations. Endotoxin from Gram-negative bacteria has also been investigated for its role in attenuating or exacerbating the asthmatic response. We have created a novel model utilizing house dust extract (HDE) containing high levels of both CRA and endotoxin to induce pulmonary inflammation (PI) and airway hyperresponsiveness (AHR). A potential drawback of this model is that the HDE is in limited supply and preparation of new HDE will not contain the exact components of the HDE used to define our model system. The present study involved testing HDEs collected from various homes for their ability to cause PI and AHR. Dust collected from five homes was extracted in phosphate buffered saline overnight. The levels of CRA and endotoxin in the supernatants varied from 7·1 to 49·5 mg/ml of CRA and 1·7–6 µg/ml of endotoxin in the HDEs. Following immunization and two pulmonary exposures to HDE all five HDEs induced AHR, PI and plasma IgE levels substantially higher than normal mice. This study shows that HDE containing high levels of cockroach allergens and endotoxin collected from different sources can induce an asthma-like response in our murine model. PMID:15086384
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Garrison, McKinzie A; Crowhurst, Karin A
2014-01-01
HdeA is a periplasmic chaperone found in several gram-negative pathogenic bacteria that are linked to millions of cases of dysentery per year worldwide. After the protein becomes activated at low pH, it can bind to other periplasmic proteins, protecting them from aggregation when the bacteria travel through the stomach on their way to colonize the intestines. It has been argued that one of the major driving forces for HdeA activation is the protonation of aspartate and glutamate side chains. The goal for this study, therefore, was to investigate, at the atomic level, the structural impact of this charge neutralization on HdeA during the transition from near-neutral conditions to pH 3.0, in preparation for unfolding and activation of its chaperone capabilities. NMR spectroscopy was used to measure pKa values of Asp and Glu residues and monitor chemical shift changes. Measurements of R2/R1 ratios from relaxation experiments confirm that the protein maintains its dimer structure between pH 6.0 and 3.0. However, calculated correlation times and changes in amide protection from hydrogen/deuterium exchange experiments provide evidence for a loosening of the tertiary and quaternary structures of HdeA; in particular, the data indicate that the dimer structure becomes progressively weakened as the pH decreases. Taken together, these results provide insight into the process by which HdeA is primed to unfold and carry out its chaperone duties below pH 3.0, and it also demonstrates that neutralization of aspartate and glutamate residues is not likely to be the sole trigger for HdeA dissociation and unfolding. PMID:24375557
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A new method for water quality assessment: by harmony degree equation.
Zuo, Qiting; Han, Chunhui; Liu, Jing; Ma, Junxia
2018-02-22
Water quality assessment is an important basic work in the development, utilization, management, and protection of water resources, and also a prerequisite for water safety. In this paper, the harmony degree equation (HDE) was introduced into the research of water quality assessment, and a new method for water quality assessment was proposed according to the HDE: by harmony degree equation (WQA-HDE). First of all, the calculation steps and ideas of this method were described in detail, and then, this method with some other important methods of water quality assessment (single factor assessment method, mean-type comprehensive index assessment method, and multi-level gray correlation assessment method) were used to assess the water quality of the Shaying River (the largest tributary of the Huaihe in China). For this purpose, 2 years (2013-2014) dataset of nine water quality variables covering seven monitoring sites, and approximately 189 observations were used to compare and analyze the characteristics and advantages of the new method. The results showed that the calculation steps of WQA-HDE are similar to the comprehensive assessment method, and WQA-HDE is more operational comparing with the results of other water quality assessment methods. In addition, this new method shows good flexibility by setting the judgment criteria value HD 0 of water quality; when HD 0 = 0.8, the results are closer to reality, and more realistic and reliable. Particularly, when HD 0 = 1, the results of WQA-HDE are consistent with the single factor assessment method, both methods are subject to the most stringent "one vote veto" judgment condition. So, WQA-HDE is a composite method that combines the single factor assessment and comprehensive assessment. This research not only broadens the research field of theoretical method system of harmony theory but also promotes the unity of water quality assessment method and can be used for reference in other comprehensive assessment.
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Multiscale modeling of a conditionally disordered pH-sensing chaperone.
Ahlstrom, Logan S; Law, Sean M; Dickson, Alex; Brooks, Charles L
2015-04-24
The pH-sensing chaperone HdeA promotes the survival of enteropathogenic bacteria during transit through the harshly acidic environment of the mammalian stomach. At low pH, HdeA transitions from an inactive, folded, dimer to chaperone-active, disordered, monomers to protect against the acid-induced aggregation of periplasmic proteins. Toward achieving a detailed mechanistic understanding of the pH response of HdeA, we develop a multiscale modeling approach to capture its pH-dependent thermodynamics. Our approach combines pK(a) (logarithmic acid dissociation constant) calculations from all-atom constant pH molecular dynamics simulations with coarse-grained modeling and yields new, atomic-level, insights into HdeA chaperone function that can be directly tested by experiment. "pH triggers" that significantly destabilize the dimer are each located near the N-terminus of a helix, suggesting that their neutralization at low pH destabilizes the helix macrodipole as a mechanism of monomer disordering. Moreover, we observe a non-monotonic change in the pH-dependent stability of HdeA, with maximal stability of the dimer near pH5. This affect is attributed to the protonation Glu37, which exhibits an anomalously high pK(a) value and is located within the hydrophobic dimer interface. Finally, the pH-dependent binding pathway of HdeA comprises a partially unfolded, dimeric intermediate that becomes increasingly stable relative to the native dimer at lower pH values and displays key structural features for chaperone-substrate interaction. We anticipate that the insights from our model will help inform ongoing NMR and biochemical investigations. Copyright © 2015 Elsevier Ltd. All rights reserved.
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Holtzinger, Audrey; Streeter, Philip R.; Sarangi, Farida; Hillborn, Scott; Niapour, Maryam; Ogawa, Shinichiro; Keller, Gordon
2015-01-01
The efficient generation of hepatocytes from human pluripotent stem cells (hPSCs) requires the induction of a proper endoderm population, broadly characterized by the expression of the cell surface marker CXCR4. Strategies to identify and isolate endoderm subpopulations predisposed to the liver fate do not exist. In this study, we generated mouse monoclonal antibodies against human embryonic stem cell-derived definitive endoderm with the goal of identifying cell surface markers that can be used to track the development of this germ layer and its specification to a hepatic fate. Through this approach, we identified two endoderm-specific antibodies, HDE1 and HDE2, which stain different stages of endoderm development and distinct derivative cell types. HDE1 marks a definitive endoderm population with high hepatic potential, whereas staining of HDE2 tracks with developing hepatocyte progenitors and hepatocytes. When used in combination, the staining patterns of these antibodies enable one to optimize endoderm induction and hepatic specification from any hPSC line. PMID:26493401
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Tsallis holographic dark energy
NASA Astrophysics Data System (ADS)
Tavayef, M.; Sheykhi, A.; Bamba, Kazuharu; Moradpour, H.
2018-06-01
Employing the modified entropy-area relation suggested by Tsallis and Cirto [1], and the holographic hypothesis, a new holographic dark energy (HDE) model is proposed. Considering a flat Friedmann-Robertson-Walker (FRW) universe in which there is no interaction between the cosmos sectors, the cosmic implications of the proposed HDE are investigated. Interestingly enough, we find that the identification of IR-cutoff with the Hubble radius, can lead to the late time accelerated Universe even in the absence of interaction between two dark sectors of the Universe. This is in contrast to the standard HDE model with Hubble cutoff, which does not imply the accelerated expansion, unless the interaction is taken into account.
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21 CFR 814.122 - Confidentiality of data and information.
Code of Federal Regulations, 2014 CFR
2014-04-01
... Confidentiality of data and information. (a) Requirement for disclosure. The “HDE file” includes all data and... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Confidentiality of data and information. 814.122... record in the HDE file will be available for public disclosure in accordance with the provisions of this...
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21 CFR 814.122 - Confidentiality of data and information.
Code of Federal Regulations, 2010 CFR
2010-04-01
... Confidentiality of data and information. (a) Requirement for disclosure. The “HDE file” includes all data and... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Confidentiality of data and information. 814.122... record in the HDE file will be available for public disclosure in accordance with the provisions of this...
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21 CFR 814.122 - Confidentiality of data and information.
Code of Federal Regulations, 2013 CFR
2013-04-01
... Confidentiality of data and information. (a) Requirement for disclosure. The “HDE file” includes all data and... 21 Food and Drugs 8 2013-04-01 2013-04-01 false Confidentiality of data and information. 814.122... record in the HDE file will be available for public disclosure in accordance with the provisions of this...
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21 CFR 814.122 - Confidentiality of data and information.
Code of Federal Regulations, 2012 CFR
2012-04-01
... Confidentiality of data and information. (a) Requirement for disclosure. The “HDE file” includes all data and... 21 Food and Drugs 8 2012-04-01 2012-04-01 false Confidentiality of data and information. 814.122... record in the HDE file will be available for public disclosure in accordance with the provisions of this...
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Song, Sae Won; Bae, Yoon Jung; Lee, Dae Taek
2010-10-01
This study examines the combined effects of caloric restriction on body composition, blood lipid, and satiety in slightly overweight women by varying food density and aerobic exercise. Twenty-three women were randomly assigned to one of two groups for a four-week weight management program: the high-energy density diet plus exercise (HDE: n = 12, 22 ± 2 yrs, 65 ± 7 kg, 164 ± 5 cm, 35 ± 4 % fat) and low-energy density diet plus exercise (LDE: n = 11, 22 ± 1 yrs, 67 ± 7 kg, 161 ± 2 cm, 35 ± 4 % fat) groups. Subjects maintained a low-calorie diet (1,500 kcal/day) during the program. Isocaloric (483 ± 26 for HDE, 487 ± 27 kcal for LDE) but different weight (365 ± 68 for HDE, 814 ± 202 g for LDE) of lunch was provided. After lunch, they biked at 60% of maximum capacity for 40 minutes, five times per week. The hunger level was scaled (1: extremely hungry; 9: extremely full) at 17:30 each day. Before and after the program, the subjects' physical characteristics were measured, and fasting blood samples were drawn. The daily energy intake was 1,551 ± 259 for HDE and 1,404 ± 150 kcal for LDE (P > 0.05). After four weeks, the subjects' weights and % fat decreased for both LDE (-1.9 kg and -1.5%, P < 0.05) and HDE (-1.6 kg and -1.4%, respectively, P < 0.05). The hunger level was significantly higher for HDE (2.46 ± 0.28) than for LDE (3.10 ± 0.26) (P < 0.05). The results suggest that a low-energy density diet is more likely to be tolerated than a high-energy density diet for a weight management program combining a low-calorie diet and exercise, mainly because of a reduced hunger sensation.
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NASA Astrophysics Data System (ADS)
Fagerquist, Clifton K.; Sultan, Omar; Carter, Michelle Q.
2012-12-01
We previously reported the apparent formation of matrix adducts of 3,5-dimethoxy-4-hydroxy-cinnamic acid (sinapinic acid or SA) via covalent attachment to disulfide bond-containing proteins (HdeA, Hde, and YbgS) from bacterial cell lysates ionized by matrix-assisted laser desorption/ionization (MALDI) time-of-flight-time-of-flight tandem mass spectrometry (TOF-TOF-MS/MS) and post-source decay (PSD). We also reported the absence of adduct formation when using α-cyano-4-hydroxycinnamic acid (CHCA) matrix. Further mass spectrometric analysis of disulfide-intact and disulfide-reduced over-expressed HdeA and HdeB proteins from lysates of gene-inserted E. coli plasmids suggests covalent attachment of SA occurs not at cysteine residues but at lysine residues. In this revised hypothesis, the attachment of SA is preceded by formation of a solid phase ammonium carboxylate salt between SA and accessible lysine residues of the protein during sample preparation under acidic conditions. Laser irradiation at 355 nm of the dried sample spot results in equilibrium retrogradation followed by nucleophilic attack by the amine group of lysine at the carbonyl group of SA and subsequent amide bond formation and loss of water. The absence of CHCA adducts suggests that the electron-withdrawing effect of the α-cyano group of this matrix may inhibit salt formation and/or amide bond formation. This revised hypothesis is supported by dissociative loss of SA (-224 Da) and the amide-bound SA (-206 Da) from SA-adducted HdeA and HdeB ions by MS/MS (PSD). It is proposed that cleavage of the amide-bound SA from the lysine side-chain occurs via rearrangement involving a pentacyclic transition state followed by hydrogen abstraction/migration and loss of 3-(4-hydroxy-3,5-dimethoxyphenyl)prop-2-ynal (-206 Da).
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Medical devices; exemptions from premarket notification; class II devices--FDA, Final rule.
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).
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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...
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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...
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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...
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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...
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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...
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Xia, Hui; Huang, Weixia; Xiong, Jie; Tao, Tao; Zheng, Xiaoguo; Wei, Haibin; Yue, Yunxia; Chen, Liang; Luo, Lijun
2016-01-01
The stress-induced epimutations could be inherited over generations and play important roles in plant adaption to stressful environments. Upland rice has been domesticated in water-limited environments for thousands of years and accumulated drought-induced epimutations of DNA methylation, making it epigenetically differentiated from lowland rice. To study the epigenetic differentiation between upland and lowland rice ecotypes on their drought-resistances, the epigenetic variation was investigated in 180 rice landraces under both normal and osmotic conditions via methylation-sensitive amplified polymorphism (MSAP) technique. Great alterations (52.9~54.3% of total individual-locus combinations) of DNA methylation are recorded when rice encountering the osmotic stress. Although the general level of epigenetic differentiation was very low, considerable level of ΦST (0.134~0.187) was detected on the highly divergent epiloci (HDE). The HDE detected in normal condition tended to stay at low levels in upland rice, particularly the ones de-methylated in responses to osmotic stress. Three out of four selected HDE genes differentially expressed between upland and lowland rice under normal or stressed conditions. Moreover, once a gene at HDE was up-/down-regulated in responses to the osmotic stress, its expression under the normal condition was higher/lower in upland rice. This result suggested expressions of genes at the HDE in upland rice might be more adaptive to the osmotic stress. The epigenetic divergence and its influence on the gene expression should contribute to the higher drought-resistance in upland rice as it is domesticated in the water-limited environment.
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Xiong, Jie; Tao, Tao; Zheng, Xiaoguo; Wei, Haibin; Yue, Yunxia; Chen, Liang; Luo, Lijun
2016-01-01
The stress-induced epimutations could be inherited over generations and play important roles in plant adaption to stressful environments. Upland rice has been domesticated in water-limited environments for thousands of years and accumulated drought-induced epimutations of DNA methylation, making it epigenetically differentiated from lowland rice. To study the epigenetic differentiation between upland and lowland rice ecotypes on their drought-resistances, the epigenetic variation was investigated in 180 rice landraces under both normal and osmotic conditions via methylation-sensitive amplified polymorphism (MSAP) technique. Great alterations (52.9~54.3% of total individual-locus combinations) of DNA methylation are recorded when rice encountering the osmotic stress. Although the general level of epigenetic differentiation was very low, considerable level of ΦST (0.134~0.187) was detected on the highly divergent epiloci (HDE). The HDE detected in normal condition tended to stay at low levels in upland rice, particularly the ones de-methylated in responses to osmotic stress. Three out of four selected HDE genes differentially expressed between upland and lowland rice under normal or stressed conditions. Moreover, once a gene at HDE was up-/down-regulated in responses to the osmotic stress, its expression under the normal condition was higher/lower in upland rice. This result suggested expressions of genes at the HDE in upland rice might be more adaptive to the osmotic stress. The epigenetic divergence and its influence on the gene expression should contribute to the higher drought-resistance in upland rice as it is domesticated in the water-limited environment. PMID:27380174
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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...
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USDA-ARS?s Scientific Manuscript database
We previously reported the apparent formation of matrix adducts of 3,5-dimethoxy-4-hydroxy-cinnamic acid (sinapinic acid or SA) via covalent attachment to disulfide bond-containing proteins (HdeA, HdeB and YbgS) from bacterial cell lysates ionized by matrix-assisted laser desorption/ionization (MALD...
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New holographic dark energy model with constant bulk viscosity in modified f(R,T) gravity theory
NASA Astrophysics Data System (ADS)
Srivastava, Milan; Singh, C. P.
2018-06-01
The aim of this paper is to study new holographic dark energy (HDE) model in modified f(R,T) gravity theory within the framework of a flat Friedmann-Robertson-Walker model with bulk viscous matter content. It is thought that the negative pressure caused by the bulk viscosity can play the role of dark energy component, and drive the accelerating expansion of the universe. This is the motive of this paper to observe such phenomena with bulk viscosity. In the specific model f(R,T)=R+λ T, where R is the Ricci scalar, T the trace of the energy-momentum tensor and λ is a constant, we find the solution for non-viscous and viscous new HDE models. We analyze new HDE model with constant bulk viscosity, ζ =ζ 0= const. to explain the present accelerated expansion of the universe. We classify all possible scenarios (deceleration, acceleration and their transition) with possible positive and negative ranges of λ over the constraint on ζ 0 to analyze the evolution of the universe. We obtain the solutions of scale factor and deceleration parameter, and discuss the evolution of the universe. We observe the future finite-time singularities of type I and III at a finite time under certain constraints on λ . We also investigate the statefinder and Om diagnostics of the viscous new HDE model to discriminate with other existing dark energy models. In late time the viscous new HDE model approaches to Λ CDM model. We also discuss the thermodynamics and entropy of the model and find that it satisfies the second law of thermodynamics.
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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...
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NASA Astrophysics Data System (ADS)
Sasaki, Daisuke; Anh, Le Duc; Nam Hai, Pham; Tanaka, Masaaki
2014-04-01
We systematically investigated the influence of strain on the electronic structure and ferromagnetism of (In,Fe)As thin films. It is found that while the shift of the critical point energies of compressive-strained (In,Fe)As layers grown on (In1-y,Gay)As (y = 0.05, 0.1) buffer layers can be explained by the hydrostatic deformation effect (HDE) alone, those of tensile-strained (In,Fe)As layers grown on (Ga1-z,Alz)Sb (z = 0, 0.5, 1) buffer layers can be explained by the combination of HDE and the quantum confinement effect (QCE). The Curie temperature TC of the (In,Fe)As layers strongly depends on the strain, and shows a maximum for the (In,Fe)As layer grown on a GaSb buffer layer. The strain dependence of TC can be explained by the s-d exchange mechanism taking into account HDE and QCE.
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Li, Xin; Wang, Jun; Zhang, Xiaojian; Chen, Chao
2015-06-01
Powdered activated carbon (PAC) adsorption of two fishy odorants, trans,trans-2,4-heptadienal (HDE) and trans,trans-2,4-decadienal (DDE), was investigated. Both the pseudo first-order and the pseudo second-order kinetic models well described the kinetics curves, and DDE was more readily removed by PAC. In isotherm tests, both Freundlich and Modified Freundlich isotherms fitted the experimental data well. PAC exhibited a higher adsorption capacity for DDE than for HDE, which could be ascribed to the difference in their hydrophobicity. The calculated thermodynamic parameters (ΔG0, ΔH0, and ΔS0) indicated an exothermic and spontaneous adsorption process. PAC dosage, pH, and natural organic matter (NOM) presence were found to influence the adsorption process. With increasing PAC dosage, the pseudo first-order and pseudo second-order rate constants both increased. The value of pH had little influence on HDE or DDE molecules but altered the surface charge of PAC, and the maximum adsorption capacity occurred at pH9. The presence of NOM, especially the fraction with molecular weight less than 1k Dalton, hindered the adsorption. The study showed that preloaded NOM impaired the adsorption capacity of HDE or DDE more severely than simultaneously fed NOM did. Copyright © 2015. Published by Elsevier B.V.
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Survey of Laser-Produced Pressure and Impulse Data
1988-01-01
Marseille, Marseille, France; C.E.A. Limeil-Service H.D.E., St. Georges , France Experimental Conditions: Laser: TEA C02 Wavelength: 10.6 pm Pulse energy: to...Mecanique des Fluides de Marseille, Marseille, France; C.E.A. Limeil-Service H.D.E., St. Georges , France Experimental Conditions: Laser: TEA CO2 Wavelength...34 Authors : C.L. Bohn, M.D. Stephen, F. Eng, J.C. Souders, G.A. Brost , T.F. Deaton, B.W. Duvall, and J.T. Tinsley Citation: "Mechanical coupling of an
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Planck constraints on holographic dark energy
NASA Astrophysics Data System (ADS)
Li, Miao; Li, Xiao-Dong; Ma, Yin-Zhe; Zhang, Xin; Zhang, Zhenhui
2013-09-01
We perform a detailed investigation on the cosmological constraints on the holographic dark energy (HDE) model by using the Plank data. We find that HDE can provide a good fit to the Plank high-l (l gtrsim 40) temperature power spectrum, while the discrepancy at l simeq 20-40 found in the ΛCDM model remains unsolved in the HDE model. The Plank data alone can lead to strong and reliable constraint on the HDE parameter c. At the 68% confidence level (CL), we obtain c = 0.508 ± 0.207 with Plank+WP+lensing, favoring the present phantom behavior of HDE at the more than 2σ CL. By combining Plank+WP with the external astrophysical data sets, i.e. the BAO measurements from 6dFGS+SDSS DR7(R)+BOSS DR9, the direct Hubble constant measurement result (H0 = 73.8 ± 2.4 kms-1Mpc-1) from the HST, the SNLS3 supernovae data set, and Union2.1 supernovae data set, we get the 68% CL constraint results c = 0.484 ± 0.070, 0.474 ± 0.049, 0.594 ± 0.051, and 0.642 ± 0.066, respectively. The constraints can be improved by 2%-15% if we further add the Plank lensing data into the analysis. Compared with the WMAP-9 results, the Plank results reduce the error by 30%-60%, and prefer a phantom-like HDE at higher significant level. We also investigate the tension between different data sets. We find no evident tension when we combine Plank data with BAO and HST. Especially, we find that the strong correlation between Ωmh3 and dark energy parameters is helpful in relieving the tension between the Plank and HST measurements. The residual value of χ2Plank+WP+HST-χ2Plank+WP is 7.8 in the ΛCDM model, and is reduced to 1.0 or 0.3 if we switch the dark energy to w model or the holographic model. When we introduce supernovae data sets into the analysis, some tension appears. We find that the SNLS3 data set is in tension with all other data sets; for example, for the Plank+WP, WMAP-9 and BAO+HST, the corresponding Δχ2 is equal to 6.4, 3.5 and 4.1, respectively. As a comparison, the Union2.1 data set is consistent with these three data sets, but the combination Union2.1+BAO+HST is in tension with Plank+WP+lensing, corresponding to a large Δχ2 that is equal to 8.6 (1.4% probability). Thus, combining internal inconsistent data sets (SNIa+BAO+HST with Plank+WP+lensing) can lead to ambiguous results, and it is necessary to perform the HDE data analysis for each independent data sets. Our tightest self-consistent constraint is c = 0.495 ± 0.039 obtained from Plank+WP+BAO+HST+lensing.
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NASA Astrophysics Data System (ADS)
Bochkarev, N. G.; Karitskaya, E. A.; Shimanskii, V. V.; Galazutdinov, G. A.
2013-10-01
By means of synthetic spectrum modeling with non-LTE effects, we determined element abundances in the atmospheres of two O supergiants with similar physical characteristics: HDE 226868 (the optical component of Cyg X-1) and α Cam. These objects are situated at the distance about 2.5 kpc from each other. HDE 226868 has higher abundances compared to α Cam. The differences of Al, S, Zn, and averaged CNO abundances are within 0.15-0.30 dex. This is in a good qualitative agreement with the inhomogeneity of the heavy-element distribution over the Galactic disk derived by Luck et al. (2006) from Cepheids. This finding confirms the inhomogeneity of chemical-element distribution on the scale of 2 kpc and is in agreement with the concept of interstellar-matter superclouds preserving their intrinsic particularities on a time scale in excess of 1 Gyr.
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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...
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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...
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Anti-dentine antibodies with root resorption during orthodontic treatment.
Ramos, Solange de Paula; Ortolan, Geórgia Oliveira; Dos Santos, Lívia Marques; Tobouti, Priscila Lie; Hidalgo, Miriam Marubayashi; Consolaro, Alberto; Itano, Eiko Nakagawa
2011-10-01
The aim of this study was to analyse serum IgG levels and salivary secretory IgA (sIgA) levels in human dentine extract (HDE) before (T0) and 6 months after (T6) orthodontic treatment and to correlate anti-HDE autoantibodies to root resorption. Fifty orthodontic patients were selected, 19 males (15.6 ± 8.5 years) and 31 females (21.4 ± 11.2 years), 19 in the mixed dentition (10.3 ± 1.9 years) and 31 in the permanent dentition (24.6 ± 9.9 years). Fifty individuals not undergoing orthodontic treatment matched by gender and age were selected as the controls. Periapical radiographs of the upper central incisors and saliva sampling were obtained of all patients at T0 and T6. Serum samples were collected from the permanent dentition patients (n = 31). Antibody levels were determined by means of immunoenzyme assay. At T6, root resorption was classified as grade 0 (no resorption), grade 1 (slight resorption), and grade 2 (moderate to severe resorption). Differences between antibody levels at T0 and T6 and among different grades of resorption were determined by paired t- and Kruskal-Wallis tests, respectively. Spearman's rank correlation coefficient was applied to detect correlation between sIgA and IgG levels, and logistic regression to determine the association of root resorption grade and the studied variables. Differences were considered significant at P < 0.05. Serum anti-HDE IgG levels decreased (P < 0.01) in grade 2 root resorption patients during treatment and was not correlated to salivary sIgA levels or other variables. Patients who had grade 2 root resorption at T6 showed higher levels of anti-HDE sIgA (P < 0.001). Anti-HDE sIgA levels at T0 and root shape were the main factors associated with the degree of root resorption. The results suggest that variations to systemic and local humoural immune response to dentine antigens may occur during orthodontic treatment. High levels of salivary sIgA before treatment were associated with more advanced lesions after 6 months of treatment.
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Capone, A; Cicchetti, A; Mennini, F S; Marcellusi, A; Baio, G; Favato, G
2016-01-01
Healthcare expenses will be the most relevant policy issue for most governments in the EU and in the USA. This expenditure can be associated with two major key categories: demographic and economic drivers. Factors driving healthcare expenditure were rarely recognised, measured and comprehended. An improvement of health data generation and analysis is mandatory, and in order to tackle healthcare spending growth, it may be useful to design and implement an effective, advanced system to generate and analyse these data. A methodological approach relied upon the Health Data Entanglement (HDE) can be a suitable option. By definition, in the HDE a large amount of data sets having several sources are functionally interconnected and computed through learning machines that generate patterns of highly probable future health conditions of a population. Entanglement concept is borrowed from quantum physics and means that multiple particles (information) are linked together in a way such that the measurement of one particle's quantum state (individual health conditions and related economic requirements) determines the possible quantum states of other particles (population health forecasts to predict their impact). The value created by the HDE is based on the combined evaluation of clinical, economic and social effects generated by health interventions. To predict the future health conditions of a population, analyses of data are performed using self-learning AI, in which sequential decisions are based on Bayesian algorithmic probabilities. HDE and AI-based analysis can be adopted to improve the effectiveness of the health governance system in ways that also lead to better quality of care.
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Shimada, Yuichi J; Yamashita, Takeshi; Koretsune, Yukihiro; Kimura, Tetsuya; Abe, Kenji; Sasaki, Shunichi; Mercuri, Michele; Ruff, Christian T; Giugliano, Robert P
2015-01-01
In 21,105 patients with atrial fibrillation in the ENGAGE AF-TIMI 48 trial, edoxaban was non-inferior to warfarin in preventing thromboembolic events while reducing bleeding. We compared results in Japan with the rest of East Asia (EA), including China, Korea, and Taiwan. We compared baseline characteristics, time-in-therapeutic range (TTR) for warfarin, and outcomes (efficacy: stroke or systemic embolic events [SEE], safety: major bleeding). Interaction P values were used to assess for effect modification of treatment (higher-dose edoxaban [HDE, 60 mg/30 mg] vs. warfarin; lower-dose edoxaban [LDE, 30 mg/15 mg] vs. warfarin) by region with adjustments for baseline characteristics. Fewer patients in Japan (n=1,010) were female, taking aspirin or amiodarone, naïve to warfarin (P<0.001 for each), had a history of stroke or transient ischemic attack (P=0.02), and more patients needed dose reduction (P<0.001) compared with EA (n=933). The mean TTR was higher in Japan (70% vs. 56%, P<0.001). Evidence for statistical interactions was observed for HDE vs. warfarin by region for stroke/SEE (adjusted P-int=0.052) and major bleeding (adjusted P-int=0.048) with greater relative efficacy and safety with HDE in EA compared with Japan. No interactions were observed for LDE vs. warfarin after adjustment. HDE had a greater relative efficacy and safety in EA compared with Japan that was only partially explained by differences in baseline characteristics and TTR.
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Kayode, Rowland Monday Ojo; Afolayan, Anthony Jide
2015-01-01
Renewed interest in natural materials as food flavors and preservatives has led to the search for suitable essential oils. Moringa oleifera seed essential oil was extracted by solvent-free microwave and hydrodistillation. This study assessed its chemical constituents. Cytotoxicity of the oils was investigated using hatchability and lethality tests on brine shrimps. A total of 16 and 26 compounds were isolated from the hydrodistillation extraction (HDE) and solvent-free microwave extraction (SME) oils, respectively, which accounted for 97.515% and 97.816% of total identifiable constituents, respectively. At 24 h when the most eggs had hatched, values of the SME (56.7%) and HDE (60.0%) oils were significantly different (P<0.05) from those of sea water (63.3%) and chloramphenicol (15.0%). Larva lethality was different significantly (P<0.05) between HDE and SME oils at different concentrations and incubation periods. The median lethal concentration (LC50) of the oils was >1000 mg/ml recommended as an index for non-toxicity, which gives the oil advantage over some antioxidant, antimicrobial, therapeutic, and preservative chemicals. PMID:26238543
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New holographic dark energy model inspired by the DGP braneworld
NASA Astrophysics Data System (ADS)
Sheykhi, A.; Dehghani, M. H.; Ghaffari, S.
2016-11-01
The energy density of the holographic dark energy (HDE) is based on the area law of entropy, and thus any modification of the area law leads to a modified holographic energy density. Inspired by the entropy expression associated with the apparent horizon of a Friedmann-Robertson-Walker (FRW) universe in DGP braneworld, we propose a new model for the HDE in the framework of DGP brane cosmology. We investigate the cosmological consequences of this new model and calculate the equation of state (EoS) parameter by choosing the Hubble radius, L = H-1, as the system’s IR cutoff. Our study show that, due to the effects of the extra dimension (bulk), the identification of IR cutoff with Hubble radius, can reproduce the present acceleration of the universe expansion. This is in contrast to the ordinary HDE in standard cosmology which leads to the zero EoS parameter in the case of choosing the Hubble radius as system’s IR cutoff in the absence of interaction between dark matter (DM) and dark energy (DE).
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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...
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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).
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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
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Ultraviolet, X-ray, and infrared observations of HDE 226868 equals Cygnus X-1
NASA Technical Reports Server (NTRS)
Treves, A.; Chiappetti, L.; Tanzi, E. G.; Tarenghi, M.; Gursky, H.; Dupree, A. K.; Hartmann, L. W.; Raymond, J.; Davis, R. J.; Black, J.
1980-01-01
During April, May, and July of 1978, HDE 226868, the optical counterpart of Cygnus X-1, was repeatedly observed in the ultraviolet with the IUE satellite. Some X-ray and infrared observations have been made during the same period. The general shape of the spectrum is that expected from a late O supergiant. Strong absorption features are apparent in the ultraviolet, some of which have been identified. The equivalent widths of the most prominent lines appear to be modulated with the orbital phase. This modulation is discussed in terms of the ionization contours calculated by Hatchett and McCray, for a binary X-ray source in the stellar wind of the companion.
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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Searching for sterile neutrinos in dynamical dark energy cosmologies
NASA Astrophysics Data System (ADS)
Feng, Lu; Zhang, Jing-Fei; Zhang, Xin
2018-05-01
We investigate how the dark energy properties change the cosmological limits on sterile neutrino parameters by using recent cosmological observations. We consider the simplest dynamical dark energy models, the wCDM model and the holographic dark energy (HDE) model, to make an analysis. The cosmological observations used in this work include the Planck 2015 CMB temperature and polarization data, the baryon acoustic oscillation data, the type Ia supernova data, the Hubble constant direct measurement data, and the Planck CMB lensing data. We find that, m v,terile ff < 0.2675 eV and Ne f f < 3.5718 for ACDM cosmology, m v,terile ff < 0.5313 eV and Ne f f < 3.5008 for wCDM cosmology, and raffterile < 0.1989 eV and Ne f f < 3.6701 for HDE cosmology, from the constraints of the combination of these data. Thus, without the addition of measurements of growth of structure, only upper limits on both m v,terile ff and Ne f f can be derived, indicating that no evidence of the existence of a sterile neutrino species with eV-scale mass is found in this analysis. Moreover, compared to the ACDM model, in the wCDM model the limit on m v,terile ff becomes much looser, but in the HDE model the limit becomes much tighter. Therefore, the dark energy properties could significantly influence the constraint limits of sterile neutrino parameters.
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Weng, Shuo-Chun; Shu, Kuo-Hsiung; Wu, Ming-Ju; Wen, Mei-Chin; Hsieh, Shie-Liang; Chen, Nien-Jung; Tarng, Der-Cherng
2015-09-03
Decoy receptor 3 (DcR3) expression in kidneys has been shown to predict progression of chronic kidney disease. We prospectively investigated a cohort comprising 96 renal transplant recipients (RTRs) undergoing graft kidney biopsies. Computer-assisted quantitative immunohistochemical staining value of DcR3 in renal tubular epithelial cells (RTECs) was used to determine the predictive role of DcR3 in kidney disease progression. The primary end point was doubling of serum creatinine and/or graft failure. A multivariate Cox proportional hazards model was used to assess the risk of DcR3 expression in rejected kidney grafts toward the renal end point. In total, RTRs with kidney allograft rejection were evaluated and the median follow-up was 30.9 months. The greater expression of DcR3 immunoreactivity in RTECs was correlated with a higher rate of the histopathological concordance of acute T cell-mediated rejection. Compared with 65 non-progressors, 31 progressors had higher DcR3 expression (HDE) regardless of the traditional risk factors. Cox regression analysis showed HDE was significantly associated with the risk of renal end point with a hazard ratio of 3.19 (95% confidence interval, 1.40 to 7.27; P = 0.006) after adjusting for other variables. In repetitive biopsies, HDE in tissue showed rapid kidney disease progression due to persistent inflammation.
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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...
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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...
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Gunsolus, Ian L; Jaffe, Allan S; Sexter, Anne; Schulz, Karen; Ler, Ranka; Lindgren, Brittany; Saenger, Amy K; Love, Sara A; Apple, Fred S
2017-12-01
Our purpose was to determine a) overall and sex-specific 99th percentile upper reference limits (URL) and b) influences of statistical methods and comorbidities on the URLs. Heparin plasma from 838 normal subjects (423 men, 415 women) were obtained from the AACC (Universal Sample Bank). The cobas e602 measured cTnT (Roche Gen 5 assay); limit of detection (LoD), 3ng/L. Hemoglobin A1c (URL 6.5%), NT-proBNP (URL 125ng/L) and eGFR (60mL/min/1.73m 2 ) were measured, along with identification of statin use, to better define normality. 99th percentile URLs were determined by the non-parametric (NP), Harrell-Davis Estimator (HDE) and Robust (R) methods. 355 men and 339 women remained after exclusions. Overall<50% of subjects had measureable concentrations ≥ LoD: 45.6% no exclusion, 43.5% after exclusion; compared to men: 68.1% no exclusion, 65.1% post exclusion; women: 22.7% no exclusion, 20.9% post exclusion. The statistical method used influenced URLs as follows: pre/post exclusion overall, NP 16/16ng/L, HDE 17/17ng/L, R not available; men NP 18/16ng/L, HDE 21/19ng/L, R 16/11ng/L; women NP 13/10ng/L, HDE 14/14ng/L, R not available. We demonstrated that a) the Gen 5 cTnT assay does not meet the IFCC guideline for high-sensitivity assays, b) surrogate biomarkers significantly lowers the URLs and c) statistical methods used impact URLs. Our data suggest lower sex-specific cTnT 99th percentiles than reported in the FDA approved package insert. We emphasize the importance of detailing the criteria used to include and exclude subjects for defining a healthy population and the statistical method used to calculate 99th percentiles and identify outliers. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.
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van den Hurk, Katja; Zalpuri, Saurabh; Prinsze, Femmeke J; Merz, Eva-Maria; de Kort, Wim L A M
2017-01-01
In donor health research, the 'Healthy Donor Effect' (HDE) often biases study results and hampers their interpretation. This refers to the fact that donors are a selected 'healthier' subset of a population due to both donor selection procedures and self-selection. Donors with long versus short donor careers, or with high versus low donation intensities are often compared to avoid this HDE, but underlying health differences might also cause these differences in behaviour. Our aim was to estimate to what extent a donor´s perceived health status associates with donation cessation and intensity. All active whole blood donors participating in Donor InSight (2007-2009; 11,107 male; 12,616 female) were included in this prospective cohort study. We performed Cox survival and Poisson regression analyses to assess whether self-reported health status, medication use, disease diagnosed by a physician and recently having consulted a general practitioner (GP) or specialist were associated with (time to) donation cessation and donation intensity. At the end of 2013, 44% of the donors in this study had stopped donating. Donors in self-rated good health had a 15% lower risk to stop donating compared to donors in perceived poorer health. Medication use, disease diagnoses and consulting a GP were associated with a 20-40% increased risk to stop donating and a lower donation intensity, when adjusting for age, number of donations and new donor status. Both men and women reporting good health made on average 10% more donations. Donors with a "good" health status were less likely to stop donating blood and tended to donate blood more often than donors with perceived poorer health status. This implies that the HDE is an important source of selection bias in studies on donor health and this includes studies where comparisons within donors are made. This HDE should be adjusted for appropriately when assessing health effects of donation and donors' health status may provide estimates of future donation behavior.
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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...
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Collaborative observations of HDE 332077
NASA Technical Reports Server (NTRS)
Ake, Thomas B., III
1995-01-01
IUE low dispersion observations were made of the T(sub c)-deficient peculiar red giant (PRG) star, HDE 332077, to test the hypothesis that T(sub c)-poor PRG's are formed as a result of mass transfer from a binary companion rather than from internal thermal pulsing while on the asymptotic red giant branch. Previous ground-based observations of this star indicated that it is a binary, but the secondary star was too massive for an expected white dwarf. A deep, short wavelength prime (SWP) exposure was needed to search for evidence of an A-type main-sequence companion. We obtained a 120 minute LWP exposure (LWP 23479), followed by a collaborative 1230 minute SWP exposure (SWP 45113). These observations were combined with our earlier IUE and optical data on this PRG star to model the spectral energy distribution of the system.
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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...
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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...
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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...
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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...
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Graphene electrodes for lithium-niobate electro-optic devices.
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.
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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Wu, Vivian C H; Qiu, Xujian; de los Reyes, Benildo G; Lin, Chih-Sheng; Pan, Yingjie
2009-02-01
The possible use of cranberry concentrate (CC) as a natural food preservative was studied by examining its antimicrobial effect on the growth of Escherichia coli O157:H7 inoculated in ground beef, its organoleptical effect on beef patties, and its antimicrobial mechanism on the gene regulation level. Inoculated ground beef was added with CC and stored at 4 degrees C for 5 days. Bacteria were detected on day 0, 1, 3, and 5. Cranberry concentrate (2.5%, 5%, and 7.5% w/w) reduced total aerobic bacteria 1.5 log, 2.1 log, and 2.7 log CFU/g and E. coli O157:H7 0.4 log, 0.7 log, and 2.4 log CFU/g, respectively, when compared to the control on day 5. Fifty panelists evaluated the burgers supplemented with CC. No differences in appearance, flavor, and taste were found among burgers with 0%, 2.5%, and 5% CC. The expression of E. coli O157:H7 cyclopropane fatty acyl phospholipid synthase (cfa), hypothetical protein (hdeA), outer membrane porin protein C (ompC), hyperosmotically inducible periplasmic protein (osmY), and outer membrane protein induced after carbon starvation (slp) genes with or without CC (2.5% v/v) treatment was investigated by quantitative real-time PCR. Compared to the control, slp, hdeA, and cfa were markedly downregulated, ompC was slightly downregulated, while osmY was slightly affected.
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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A two-in-one Faraday rotator mirror exempt of active optical alignment.
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.
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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...
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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...
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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...
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Gutiérrez, Liliana; García, José R; Rincón, María de Jesús; Ceballos, Guillermo M; Olivares, Ivonne M
2015-07-06
Obesity is characterized by a generalized increase of adipose tissue, high production of adipocytokines and presence of oxidative systemic stress. The objective of this study was to evaluate the changes generated in the oxidative stress and anthropometric parameters in obese subjects by the prescription of a hypocaloric diet in combination with moderate aerobic exercise and supplementation with antioxidants. Oxidative damage was determined in the plasma from 30 normal weight and 30 obese subjects. Three groups of treatment were established: Hypocaloric diet (HD), HD plus moderate aerobic exercise (HDE) and HDE plus antioxidants (DHEA). Biomarkers of oxidative stress (thiobarbituric acid reactive substances [TBARS], carbonyl groups, dityrosine) and anthropometric parameters were determined. Higher values of biomarkers of oxidative damage were observed in obese (TBARS 13.74 ± 1.2 μM; carbonyl groups 0.89 ± 0.04 nmol of osazone/mg of protein; dityrosine 478.9 ± 27.4 RFU/mg of protein) in comparison to normal weight subjects (TBARS 7.08 ± 0.8 μM; carbonyl groups 0.65 ± 0.04 nmol of osazone/mg of protein; dityrosine 126.3 ± 12.6 RFU/mg of protein), thus showing the presence of an oxidative damage. The prescription of HD decreased the oxidative damage and anthropometric parameters in the obese subjects. We did not observe additional benefit effects on these determinations with HDE or HDEA treatments. We demonstrated that an HD decreases the oxidative damage in obese subjects. Oxidative stress is an important factor in the development of comorbidity in obesity. Therefore, the prescription of a HD could be a key issue in the treatment of the disease. Copyright © 2013 Elsevier España, S.L.U. All rights reserved.
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Two K Giants with Supermeteoritic Lithium Abundances: HDE 233517 and HD 9746
NASA Astrophysics Data System (ADS)
Balachandran, Suchitra C.; Fekel, Francis C.; Henry, Gregory W.; Uitenbroek, Han
2000-10-01
Two unusual Li-rich K giants, HDE 233517 and HD 9746, have been studied. Optical spectroscopy and photometry have been obtained to determine the fundamental parameters of HDE 233517, a single K2 III with an extremely large infrared excess. The spectra yield Teff=4475 K, logg=2.25, [Fe/H]=-0.37, vsini=17.6 km s-1, and a non-LTE logɛ(7Li)=4.22. Photometric observations reveal low-amplitude light variability with a period of 47.9 days. Combined with other parameters, this results in a minimum radius of 16.7 Rsolar and minimum distance of 617 pc. Comparison of spectra obtained in 1994 and 1996 show profile variations in Hα and the Na D lines indicative of changing mass loss. Optical spectra of HD 9746, a chromospherically active giant, were analyzed. The Teff=4400 K and revised Hipparcos-based gravity of logg=2.30 lead to a non-LTE logɛ(7Li)=3.75. The Li abundances in both stars are supermeteoritic. By the inclusion and exclusion of 6Li in the syntheses, we show that consistent 7Li abundances are obtained only when 6Li is absent in the synthetic fit. This provides evidence for fresh 7Li production and excludes both preservation of primordial Li and planetary accretion as viable scenarios for the formation of Li-rich giants. Both stars lie in close proximity to the red giant luminosity bump supporting the hypothesis that 7Li production is caused by the same mixing mechanism that later results in CN processing and lowers the 12C/13C ratio to nonstandard values.
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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NASA Astrophysics Data System (ADS)
Karitskaya, E. A.; Bochkarev, N. G.; Shimansky, V. V.; Galazutdinov, G. A.
2011-09-01
Chemical abundances derived for two O-type supergiants with similar parameters confirm the inhomogeneity of heavy-element distribution on a scale of 2 kpc and a lifetime of ISM superclouds exceeding 1 Gyr.
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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Technology Readiness Assessment (TRA) Deskbook
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
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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.
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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...
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NASA Astrophysics Data System (ADS)
Expósito, E.; Sánchez-Sánchez, C. M.; Solla-Gullón, J.; Montiel, V.
The influence of Pb 2+ ions in sulfuric acid medium on the behavior of a platinum catalyzed hydrogen diffusion electrode (HDE) in a filter press reactor has been studied. A voltammetric study of the H 2 oxidation reaction on a polyoriented platinum electrode and a platinum rotating disk electrode (RDE) in presence of lead ions in solution has also been carried out. Potential oscillations were found in galvanostatic experiments of H 2 oxidation using a HDE catalyzed with platinum when Pb 2+ ions are present in solution. This oscillatory phenomenon was also observed when hydrogen oxidation was carried out in presence of Pb 2+ ions using a platinum RDE. The oscillatory behavior observed has been attributed to an adsorption-oxidation-desorption process of lead on the platinum surface. Due to the low solubility of Pb 2+ in sulfuric acid, at high values of coverage, lead is oxidised to insoluble lead sulfate that blocks the Pt surface. The coupling of the dissolution of lead sulfate and the Pb electrochemical adsorption-oxidation processes cause the oscillatory phenomenon.
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Shalaby, Karim H; Lyons-Cohen, Miranda R; Whitehead, Gregory S; Thomas, Seddon Y; Prinz, Immo; Nakano, Hideki; Cook, Donald N
2017-11-14
Mechanisms that elicit mucosal T H 17 cell responses have been described, yet how these cells are sustained in chronically inflamed tissues remains unclear. We sought to understand whether maintenance of lung T H 17 inflammation requires environmental agents in addition to antigen and to identify the lung antigen-presenting cell (APC) types that sustain the self-renewal of T H 17 cells. Animals were exposed repeatedly to aspiration of ovalbumin alone or together with environmental adjuvants, including common house dust extract (HDE), to test their role in maintaining lung inflammation. Alternatively, antigen-specific effector/memory T H 17 cells, generated in culture with CD4 + T cells from Il17a fate-mapping mice, were adoptively transferred to assess their persistence in genetically modified animals lacking distinct lung APC subsets or cell-specific Toll-like receptor (TLR) 4 signaling. T H 17 cells were also cocultured with lung APC subsets to determine which of these could revive their expansion and activation. T H 17 cells and the consequent neutrophilic inflammation were poorly sustained by inhaled antigen alone but were augmented by inhalation of antigen together with HDE. This was associated with weight loss and changes in lung physiology consistent with interstitial lung disease. The effect of HDE required TLR4 signaling predominantly in lung hematopoietic cells, including CD11c + cells. CD103 + and CD11b + conventional dendritic cells interacted directly with T H 17 cells in situ and revived the clonal expansion of T H 17 cells both ex vivo and in vivo, whereas lung macrophages and B cells could not. T H 17-dependent inflammation in the lungs can be sustained by persistent TLR4-mediated activation of lung conventional dendritic cells. Published by Elsevier Inc.
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Codispoti, Christopher D; Levin, Linda; LeMasters, Grace K; Ryan, Patrick; Reponen, Tiina; Villareal, Manuel; Burkle, Jeff; Stanforth, Sherry; Lockey, James E; Khurana Hershey, Gurjit K; Bernstein, David I
2010-05-01
Infant predictors of early childhood allergic rhinitis (AR) are poorly understood. We sought to identify environmental exposures and host factors during infancy that predict AR at age 3 years. High-risk children from greater Cincinnati were followed annually from ages 1 to 3 years. AR was defined as sneezing, runny, or blocked nose in the prior 12 months and a positive skin prick test (SPT) response to 1 or more aeroallergens. Environmental and standardized medical questionnaires determined exposures and clinical outcomes. Primary activity area dust samples were analyzed for house dust endotoxin (HDE) and (1-3)-beta-D-glucan. Fine particulate matter sampled at 27 monitoring stations was used to estimate personal elemental carbon attributable to traffic exposure by using a land-use regression model. Of 361 children in this analysis, 116 had AR, and 245 were nonatopic and nonsymptomatic. Prolonged breast-feeding in African American children (adjusted odds ratio [aOR], 0.8; 95% CI, 0.6-0.9) and multiple children in the home during infancy was protective against AR (aOR, 0.4; 95% CI, 0.2-0.8). Food SPT response positivity and tree SPT response positivity in infancy increased the risk of AR at age 3 years (aOR of 4.4 [95% CI, 2.1-9.2] and aOR of 6.8 [95% CI, 2.5-18.7], respectively). HDE exposure was associated with AR; the effect was dependent on exposure level. Elemental carbon attributable to traffic and environmental tobacco smoke exposure showed no effect on AR. Prolonged breast-feeding in African American subjects and multiple children in the home during infancy reduced the risk of AR at age 3 years. SPT response positivity to food and tree allergens enhanced risk. The HDE effect on AR was related to exposure. Copyright 2010 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.
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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...
-
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...
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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...
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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...
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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...
-
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...
-
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...
-
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...
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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...
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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...
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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...
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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...
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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...
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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...
-
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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
-
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...
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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...
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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...
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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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
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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.…
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Wang, Lin; Qu, Hui; Liu, Shan; Dun, Cai-xia
2013-01-01
As a practical inventory and transportation problem, it is important to synthesize several objectives for the joint replenishment and delivery (JRD) decision. In this paper, a new multiobjective stochastic JRD (MSJRD) of the one-warehouse and n-retailer systems considering the balance of service level and total cost simultaneously is proposed. The goal of this problem is to decide the reasonable replenishment interval, safety stock factor, and traveling routing. Secondly, two approaches are designed to handle this complex multi-objective optimization problem. Linear programming (LP) approach converts the multi-objective to single objective, while a multi-objective evolution algorithm (MOEA) solves a multi-objective problem directly. Thirdly, three intelligent optimization algorithms, differential evolution algorithm (DE), hybrid DE (HDE), and genetic algorithm (GA), are utilized in LP-based and MOEA-based approaches. Results of the MSJRD with LP-based and MOEA-based approaches are compared by a contrastive numerical example. To analyses the nondominated solution of MOEA, a metric is also used to measure the distribution of the last generation solution. Results show that HDE outperforms DE and GA whenever LP or MOEA is adopted.
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Dun, Cai-xia
2013-01-01
As a practical inventory and transportation problem, it is important to synthesize several objectives for the joint replenishment and delivery (JRD) decision. In this paper, a new multiobjective stochastic JRD (MSJRD) of the one-warehouse and n-retailer systems considering the balance of service level and total cost simultaneously is proposed. The goal of this problem is to decide the reasonable replenishment interval, safety stock factor, and traveling routing. Secondly, two approaches are designed to handle this complex multi-objective optimization problem. Linear programming (LP) approach converts the multi-objective to single objective, while a multi-objective evolution algorithm (MOEA) solves a multi-objective problem directly. Thirdly, three intelligent optimization algorithms, differential evolution algorithm (DE), hybrid DE (HDE), and genetic algorithm (GA), are utilized in LP-based and MOEA-based approaches. Results of the MSJRD with LP-based and MOEA-based approaches are compared by a contrastive numerical example. To analyses the nondominated solution of MOEA, a metric is also used to measure the distribution of the last generation solution. Results show that HDE outperforms DE and GA whenever LP or MOEA is adopted. PMID:24302880
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VizieR Online Data Catalog: V1357 Cyg spectroscopic monitoring in 2002-04 (Karitskaya+, 2008)
NASA Astrophysics Data System (ADS)
Karitskaya, E. A.; Bochkarev, N. G.; Bondar, A. V.; Galazutdinov, G. A.; Lee, B.-K.; Musaev, F. A.; Sapar, A. A.; Shimansky, V. V.
2008-11-01
The results of Cyg X-1 = HDE 226868/V1357 Cyg optical spectral monitoring in 2002-2004 are discussed. Spectral observations were carried out on Peak Terskol Observatory (Kabardino-Balkaria, Russia, resolution R=45000 and 13000) and Bohyunsan Optical Astronomy Observatory (BOAO, Korea, R=30000, 44000). Each spectrum covers the main part of optical spectral range. During 33 observational nights 75 echelle spectra were obtained in the times of the "soft" and "hard" states of Cyg X-1. The X-ray influence on spectral line profiles was studied. The RXTE/ASM data were used for this purpose. The X-ray flare resulted in strong variations of Halpha and HeII4686{AA} emission component profiles during night. This behaviour we connect with variations of ionization structure of matter in the system. Line profile variations with the orbital phase were observed. The spectral atlas for Cyg X-1 was constructed. The contented line identification was done. There were revealed 172 lines and blends which belong to 12 chemical elements: H, He, C, N, O, Ne, Mg, Al, Si, S, Fe, Zn. The HDE 226868 spectral classification as ON star was confirmed. (2 data files).
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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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
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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...
-
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...
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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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
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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...
-
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...
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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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
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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...
-
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...
-
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...
-
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...
-
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...
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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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
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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...
-
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...
-
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...
-
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...
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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...
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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...
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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...
-
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...
-
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...
-
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...
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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...
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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...
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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...
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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...
-
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...
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Guidance for the emergency use of unapproved medical devices; availability--FDA. Notice.
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."
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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
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Initiative in Concurrent Engineering (DICE). Phase 1.
1990-02-09
and power of commercial and military electronics systems. The continual evolution of HDE technology offers far greater flexibility in circuit design... powerful magnetic field of the permanent magnets in the sawyer motors. This makes it possible to have multiple robots in the workcell and to have them...Controller. The Adept IC was chosen because of its extensive processing power , integrated grayscale vision, standard 28 industrial I/O control
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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...
-
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...
-
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...
-
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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
-
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...
-
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...
-
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...
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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...
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Evolutionary optimization with data collocation for reverse engineering of biological networks.
Tsai, Kuan-Yao; Wang, Feng-Sheng
2005-04-01
Modern experimental biology is moving away from analyses of single elements to whole-organism measurements. Such measured time-course data contain a wealth of information about the structure and dynamic of the pathway or network. The dynamic modeling of the whole systems is formulated as a reverse problem that requires a well-suited mathematical model and a very efficient computational method to identify the model structure and parameters. Numerical integration for differential equations and finding global parameter values are still two major challenges in this field of the parameter estimation of nonlinear dynamic biological systems. We compare three techniques of parameter estimation for nonlinear dynamic biological systems. In the proposed scheme, the modified collocation method is applied to convert the differential equations to the system of algebraic equations. The observed time-course data are then substituted into the algebraic system equations to decouple system interactions in order to obtain the approximate model profiles. Hybrid differential evolution (HDE) with population size of five is able to find a global solution. The method is not only suited for parameter estimation but also can be applied for structure identification. The solution obtained by HDE is then used as the starting point for a local search method to yield the refined estimates.
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Wang, Lin; Qu, Hui; Chen, Tao; Yan, Fang-Ping
2013-01-01
The integration with different decisions in the supply chain is a trend, since it can avoid the suboptimal decisions. In this paper, we provide an effective intelligent algorithm for a modified joint replenishment and location-inventory problem (JR-LIP). The problem of the JR-LIP is to determine the reasonable number and location of distribution centers (DCs), the assignment policy of customers, and the replenishment policy of DCs such that the overall cost is minimized. However, due to the JR-LIP's difficult mathematical properties, simple and effective solutions for this NP-hard problem have eluded researchers. To find an effective approach for the JR-LIP, a hybrid self-adapting differential evolution algorithm (HSDE) is designed. To verify the effectiveness of the HSDE, two intelligent algorithms that have been proven to be effective algorithms for the similar problems named genetic algorithm (GA) and hybrid DE (HDE) are chosen to compare with it. Comparative results of benchmark functions and randomly generated JR-LIPs show that HSDE outperforms GA and HDE. Moreover, a sensitive analysis of cost parameters reveals the useful managerial insight. All comparative results show that HSDE is more stable and robust in handling this complex problem especially for the large-scale problem.
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Spatiotemporal Evolution of the Wound Repairing Process in a 3D Human Dermis Equivalent.
Lombardi, Bernadette; Casale, Costantino; Imparato, Giorgia; Urciuolo, Francesco; Netti, Paolo Antonio
2017-07-01
Several skin equivalent models have been developed to investigate in vitro the re-epithelialization process occurring during wound healing. Although these models recapitulate closure dynamics of epithelial cells, they fail to capture how a wounded connective tissue rebuilds its 3D architecture until the evolution in a scar. Here, the in vitro tissue repair dynamics of a connective tissue is replicated by using a 3D human dermis equivalent (3D-HDE) model composed of fibroblasts embedded in their own extracellular matrix (ECM). After inducing a physical damage, 3D-HDE undergoes a series of cellular and extracellular events quite similar to those occurring in the native dermis. In particular, fibroblasts differentiation toward myofibroblasts phenotype and neosynthesis of hyaluronic acid, fibronectin, and collagen during the repair process are assessed. Moreover, tissue reorganization after physical damage is investigated by measuring the diameter of bundles and the orientation of fibers of the newly formed ECM network. Finally, the ultimate formation of a scar-like tissue as physiological consequence of the repair and closure process is demonstrated. Taking together, the results highlight that the presence of cell-assembled and responsive stromal components enables quantitative and qualitative in vitro evaluation of the processes involved in scarring during wound healing. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
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Chen, Tao; Yan, Fang-Ping
2013-01-01
The integration with different decisions in the supply chain is a trend, since it can avoid the suboptimal decisions. In this paper, we provide an effective intelligent algorithm for a modified joint replenishment and location-inventory problem (JR-LIP). The problem of the JR-LIP is to determine the reasonable number and location of distribution centers (DCs), the assignment policy of customers, and the replenishment policy of DCs such that the overall cost is minimized. However, due to the JR-LIP's difficult mathematical properties, simple and effective solutions for this NP-hard problem have eluded researchers. To find an effective approach for the JR-LIP, a hybrid self-adapting differential evolution algorithm (HSDE) is designed. To verify the effectiveness of the HSDE, two intelligent algorithms that have been proven to be effective algorithms for the similar problems named genetic algorithm (GA) and hybrid DE (HDE) are chosen to compare with it. Comparative results of benchmark functions and randomly generated JR-LIPs show that HSDE outperforms GA and HDE. Moreover, a sensitive analysis of cost parameters reveals the useful managerial insight. All comparative results show that HSDE is more stable and robust in handling this complex problem especially for the large-scale problem. PMID:24453822
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Spectroscopic monitoring of V1357 Cyg = Cyg X-1 in 2002-2004
NASA Astrophysics Data System (ADS)
Karitskaya, E. A.; Bochkarev, N. G.; Bondar', A. V.; Galazutdinov, G. A.; Lee, B.-C.; Musaev, F. A.; Sapar, A. A.; Shimanskii, V. V.
2008-05-01
We discuss the results of optical spectroscopic monitoring of Cyg X-1 = HDE 226868/V1357 Cyg in 2002-2004. Our spectroscopy was carried out at the Terskol Observatory (Kabarda-Balkaria, Russia; the resolving power was R = 45 000 and 13 000) and at the Bohyunsan Optical Astronomy Observatory (BOAO, Korea, R = 30 000 and 44 000). Each spectrum covers most of the optical range. We obtained a total of 75 echelle spectra on 33 nights, during both “soft” and “hard” X-ray states of Cyg X-1. We study the influence of the X-rays on spectral-line profiles using RXTE/ASM X-ray data. We find that the X-ray flare of June 13, 2003 resulted in strong variations of the emission profiles of the Hα and Hellλ4686 Å lines within a night. This behavior is due to variations of the ionization state of the gas in the system. We also analyzed line-profile variations with orbital phase. A spectral atlas of Cyg X-1 was created, and the lines it contains identified. A total of 172 stellar lines and blends belonging to 12 chemical elements (H, He, C, N, O, Ne, Mg, Al, Si, S, Fe, Zn) were identified. The spectral classification of HDE 226868 as an ON star is confirmed.
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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...
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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...
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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...
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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...
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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...
-
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...
-
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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
-
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...
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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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
-
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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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.
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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Documentation for the machine-readable version of the Henry Draper Catalogue (edition 1985)
NASA Technical Reports Server (NTRS)
Roman, N. G.; Warren, W. H., Jr.
1985-01-01
An updated, corrected and extended machine-readable version of the catalog is described. Published and unpublished errors discovered in the previous version was corrected; letters indicating supplemental stars in the BD have been moved to a new byte to distinguish them from double-star components; and the machine readable portion of The Henry Draper Extension (HDE) (HA 100) was converted to the same format as the main catalog, with additional data added as necessary.
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Enhance nisin yield via improving acid-tolerant capability of Lactococcus lactis F44.
Zhang, Jian; Caiyin, Qinggele; Feng, Wenjing; Zhao, Xiuli; Qiao, Bin; Zhao, Guangrong; Qiao, Jianjun
2016-06-16
Traditionally, nisin was produced industrially by using Lactococcus lactis in the neutral fermentation process. However, nisin showed higher activity in the acidic environment. How to balance the pH value for bacterial normal growth and nisin activity might be the key problem. In this study, 17 acid-tolerant genes and 6 lactic acid synthetic genes were introduced in L. lactis F44, respectively. Comparing to the 2810 IU/mL nisin yield of the original strain F44, the nisin titer of the engineered strains over-expressing hdeAB, ldh and murG, increased to 3850, 3979 and 4377 IU/mL, respectively. These engineered strains showed more stable intracellular pH value during the fermentation process. Improvement of lactate production could partly provide the extra energy for the expression of acid tolerance genes during growth. Co-overexpression of hdeAB, murG, and ldh(Z) in strain F44 resulted in the nisin titer of 4913 IU/mL. The engineered strain (ABGL) could grow on plates with pH 4.2, comparing to the surviving pH 4.6 of strain F44. The fed-batch fermentation showed nisin titer of the co-expression L. lactis strain could reach 5563 IU/mL with lower pH condition and longer cultivation time. This work provides a novel strategy of constructing robust strains for use in industry process.
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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.
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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...
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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...
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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...
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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.
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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.
-
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.
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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...
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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...
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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...
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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...
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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...
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Effects of radiation pressure on the equipotential surfaces in X-ray binaries
NASA Technical Reports Server (NTRS)
Kondo, Y.; Mccluskey, G. E., Jr.; Gulden, S. L.
1976-01-01
Equipotential surfaces incorporating the effect of radiation pressure were computed for the X-ray binaries Cen X-3, Cyg X-1 = HDE 226868, Vela XR-1 = 3U 0900-40 = HD 77581, and 3U 1700-37 = HD 153919. The topology of the equipotential surfaces is significantly affected by radiation pressure. In particular, the so-called critical Roche (Jacobian) lobes, the traditional figure 8's, do not exist. The effects of these results on modeling X-ray binaries are discussed.
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Analysis of interacting entropy-corrected holographic and new agegraphic dark energies
NASA Astrophysics Data System (ADS)
Ranjit, Chayan; Debnath, Ujjal
In the present work, we assume the flat FRW model of the universe is filled with dark matter and dark energy where they are interacting. For dark energy model, we consider the entropy-corrected HDE (ECHDE) model and the entropy-corrected NADE (ECNADE). For entropy-corrected models, we assume logarithmic correction and power law correction. For ECHDE model, length scale L is assumed to be Hubble horizon and future event horizon. The ωde-ωde‧ analysis for our different horizons are discussed.
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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.
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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...
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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...
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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...
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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...
-
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...
-
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...
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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...
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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)
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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...
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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...
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Active Luminous Blue Variables in the Large Magellanic Cloud
NASA Astrophysics Data System (ADS)
Walborn, Nolan R.; Gamen, Roberto C.; Morrell, Nidia I.; Barbá, Rodolfo H.; Fernández Lajús, Eduardo; Angeloni, Rodolfo
2017-07-01
We present extensive spectroscopic and photometric monitoring of two famous and currently highly active luminous blue variables (LBVs) in the Large Magellanic Cloud (LMC), together with more limited coverage of three further, lesser known members of the class. R127 was discovered as an Ofpe/WN9 star in the 1970s but entered a classical LBV outburst in or about 1980 that is still in progress, thus enlightening us about the minimum state of such objects. R71 is currently the most luminous star in the LMC and continues to provide surprises, such as the appearance of [Ca II] emission lines, as its spectral type becomes unprecedentedly late. Most recently, R71 has developed inverse P Cyg profiles in many metal lines. The other objects are as follows: HDE 269582, now a “second R127” that has been followed from Ofpe/WN9 to A type in its current outburst; HDE 269216, which changed from late B in 2014 to AF in 2016, its first observed outburst; and R143 in the 30 Doradus outskirts. The light curves and spectroscopic transformations are correlated in remarkable detail and their extreme reproducibility is emphasized, both for a given object and among all of them. It is now believed that some LBVs proceed directly to core collapse. One of these unstable LMC objects may thus oblige in the near future, teaching us even more about the final stages of massive stellar evolution.
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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...
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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...
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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...
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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...
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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...
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Lead electrowinning in a fluoborate medium. Use of hydrogen diffusion anodes
NASA Astrophysics Data System (ADS)
Expósito, E.; González-García, J.; Bonete, P.; Montiel, V.; Aldaz, A.
The results of an investigation of the electrowinning of lead employing a fluoboric acid bath are reported. The electrodeposition lead reaction was studied by voltammetric methods and scanning electron microscopy (SEM) microphotographs of the electrodeposited lead were taken. The effects of current density, temperature, catholyte flow and H + concentration were investigated on a laboratory scale to optimise operating conditions. Finally, the substitution of the traditionally used Dimensionally Stable Anode (DSA) by a Hydrogen Diffusion Electrode (HDE) was made in order to decrease the energy consumption (EC) of the overall process.
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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M6-C artificial disc placement.
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 .
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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.
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
-
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...
-
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...
-
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...
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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...
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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...
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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...
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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...
-
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...
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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...
-
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...
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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...
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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...
-
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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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Emergency Preservation and Resuscitation for Cardiac Arrest from Trauma (EPR CAT)
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
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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.