Inertial Manifolds for Navier-Stokes Equations and Related Dynamical Systems

DTIC Science & Technology

1991-05-31

Graphics IRIS (SGI). The RLE files for the animation are loaded to an Abekas and recorded to tape by Betacam . This computational work was done by using the...scripts and comments, are loaded to the Abekas-A60 digital image storage device, and then recorded to the Betacam BVW-75 analog tape recorder. Static...interfacing, huge data files are output to the Data Vault parallelly with little cost. In addition to the SGIs, Abekas, Betacam and Solitaire, the

A leap forward in the endovascular management of acute basilar artery occlusion since the appearance of stent retrievers: a single-center comparative study.

PubMed

Fahed, Robert; Di Maria, Federico; Rosso, Charlotte; Sourour, Nader; Degos, Vincent; Deltour, Sandrine; Baronnet-Chauvet, Flore; Léger, Anne; Crozier, Sophie; Gabrieli, Joseph; Samson, Yves; Chiras, Jacques; Clarençon, Frédéric

2017-05-01

OBJECTIVE Contrary to acute ischemic stroke involving the anterior circulation, no randomized trial has yet demonstrated the safety and effectiveness of endovascular management in acute basilar artery occlusion (BAO). Recently developed thrombectomy devices, such as stentrievers and aspiration systems, have helped in improving the endovascular management of acute ischemic stroke. The authors sought to assess the impact of these devices in the endovascular treatment of acute BAO. METHODS A retrospective analysis of 34 consecutive patients treated in Pitié-Salpêtrière Hospital for acute BAO was carried out. All patients had undergone an endovascular procedure. In addition to the global results in terms of safety and effectiveness (recanalization rate and 3-month clinical outcome based on the modified Rankin Scale [mRS]), the authors aimed to determine if the patients treated with the most recently developed devices (i.e., the Solitaire stentriever or the ADAPT catheter) had better angiographic and clinical outcomes than those treated with older endovascular strategies. RESULTS The overall successful recanalization rate (thrombolysis in cerebral infarction score 2b-3) was 50% (17 of 34 patients). A good clinical outcome (mRS score 0-2 at 3-month follow-up) was achieved in 11 (32.3%) of 34 patients. The mortality rate at 3-month follow-up was 29.4% (10 of 34 patients). Patients treated with the Solitaire stentriever and the ADAPT catheter had a higher recanalization rate (12 [92.3%] of 13 patients vs 5 [23.8%] of 21 patients, p = 0.0002) and a shorter mean (± SD) procedure duration (88 ± 31 minutes vs 126 ± 58 minutes, p = 0.04) than patients treated with older devices. CONCLUSIONS The latest devices have improved the effectiveness of mechanical thrombectomy in acute BAO. Their use in further studies may help demonstrate a benefit in the endovascular management of acute BAO.

Stent-thrombus interaction and the influence of aspiration on mechanical thrombectomy: evaluation of different stent retrievers in a circulation model.

PubMed

Madjidyar, Jawid; Hermes, Julian; Freitag-Wolf, Sandra; Jansen, Olav

2015-08-01

Different devices and techniques are available for endovascular treatment of ischemic stroke. In this in vitro study, we examined the stent-thrombus interaction and the influence of additional aspiration on the efficiency of mechanical thrombectomy with established stent retrievers. Human blood thrombi were made in a Chandler loop. The thrombi were placed into the middle cerebral artery of a vascular silicon phantom. A programmable piston pump was used to acquire physiological flow in the model. Resistances were interposed to gain physiological pressure. The stent retrievers Trevo, Solitaire FR, Separator 3D, and Aperio were used to perform thrombectomy under direct visual control. For the additional aspiration, we used intermediate catheters. Ten attempts per device were made with and without aspiration under standardized conditions, a total of n = 80. For all thrombectomy maneuvers, it was demonstrated that the thrombus was pushed by the stent struts against the vessel wall and was retracted along it. The stent-thrombus interaction was only superficial for all devices. Using additional distal aspiration, the amount of distal embolism and rate of embolism in new territories was significantly lower than without. Moreover, additional aspiration reduced the number of recanalization maneuvers and the recanalization time. Distal aspiration with intermediate catheters increases the efficacy of mechanical thrombectomy with stent retrievers significantly. In contrary to earlier suggestions, the interaction between the thrombus and the stent retriever is only superficial, rather than an integration of the thrombus into the retriever. No significant differences between the proven devices could be shown in our model.

Falling PC Solitaire Cards: An Open-Inquiry Approach

ERIC Educational Resources Information Center

Gonzalez-Espada, Wilson J.

2012-01-01

Many of us have played the PC Solitaire game that comes as standard software in many computers. Although I am not a great player, occasionally I win a game or two. The game celebrates my accomplishment by pushing the cards forward, one at a time, falling gracefully in what appears to look like a parabolic path in a drag-free environment. One day,…

Macrofaunal communites at newly discovered hydrothermal fields in Central Indian Ridge

NASA Astrophysics Data System (ADS)

Miyazaki, J.; Takai, K.; Nakamura, K.; Watanabe, H.; Noguchi, T.; Matsuzaki, T.; Watsuji, T.; Nemoto, S.; Kawagucci, S.; Shibuya, T.; Okamura, K.; Mochizuki, M.; Orihashi, Y.; Marie, D.; Koonjul, M.; Singh, M.; Beedessee, G.; Bhikajee, M.; Tamaki, K.

2010-12-01

In YK09-13 Leg1 cruise targeted on the segment 15 and 16 in Central Indian Ridge (CIR), we have successfully discovered two hydrothermal fields, DODO field and Solitaire field. We expected that there were unique macrofaunal communities in these hydrothermal fields, because there was in Kairei field on the segment 1 in CIR. Particularly, a gastropod, “scaly-foot”, which has sclerites covered with iron-sulfide has only discovered in Kairei field. Therefore, it was interesting whether this unique scaly-foot only exists in Kairei fields or widely expands in CIR. In DODO fields, there were 10 to 15 active chimneys. However, very few hydrothermal vent-endemic faunas were observed. We observed only crabs and shrimps but we did not found shells. As opposed to in the Dodo field, biomass and composition of macrofaunal communities were highly prosperous in the Solitaire field, being equal to Kairei field. Although we have an only one dive to explore the Solitaire field, many predominant taxa were sampled and observed, for example, Alviniconcha, mussels, vanacles and so on. However, the most outstanding feature was the presence of a new morphotype of ‘scaly-foot’ gastropod. Discovery of this new-morphytpe ‘scary-foot” disproved our knowledge. In this conference, I will present these observations. Especially characterization of two types of scaly-foot (Kairei-type and Solitaire-type) will be focused.

Comparative study of the wear behavior of composites for posterior restorations.

PubMed

Turssi, Cecilia P; Faraoni-Romano, Juliana J; de Menezes, Márcio; Serra, Mônica C

2007-01-01

This investigation sought to compare the abrasive wear rates of resin composites designed for posterior applications. Seventy-five specimens were fabricated with conventional hybrid (Charisma and Filtek Z250) or packable composites (Filtek P60, Solitaire II and Tetric Ceram HB), according to a randomized complete block design (n = 15). Specimens were finished and polished metallographically and subjected to abrasive wear which was performed under a normal load of 13N at a frequency of 2 Hz using a pneumatic device (MSM/Elquip) in the presence of a mucin-containing artificial saliva. Wear was quantified profilometrically in five different locations of each specimen after 1,000, 5,000, 10,000, 50,000 and after every each 50,000 through 250,000 cycles. A split-plot ANOVA showed a significant difference between the wear resistance of composites (alpha = 0.05). Tukey's test ascertained that while the composites Filtek Z250 and Charisma wore significantly less than any other of the materials tested, Tetric Ceram HB experienced the greatest wear rates. Filtek P60 and Solitaire II showed intermediate rates of material removal. The wear pattern of composites proved to be biphasic with the primary phase having the faster wear rate. In conclusion, packable resin composites may not have superior wear compared to conventional hybrid composites.

Efficacy of Stent-Retriever Thrombectomy in Magnetic Resonance Imaging Versus Computed Tomographic Perfusion-Selected Patients in SWIFT PRIME Trial (Solitaire FR With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke).

PubMed

Menjot de Champfleur, Nicolas; Saver, Jeffrey L; Goyal, Mayank; Jahan, Reza; Diener, Hans-Christoph; Bonafe, Alain; Levy, Elad I; Pereira, Vitor M; Cognard, Christophe; Yavagal, Dileep R; Albers, Gregory W

2017-06-01

The majority of patients enrolled in SWIFT PRIME trial (Solitaire FR With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke) had computed tomographic perfusion (CTP) imaging before randomization; 34 patients were randomized after magnetic resonance imaging (MRI). Patients with middle cerebral artery and distal carotid occlusions were randomized to treatment with tPA (tissue-type plasminogen activator) alone or tPA+stentriever thrombectomy. The primary outcome was the distribution of the modified Rankin Scale score at 90 days. Patients with the target mismatch profile for enrollment were identified on MRI and CTP. MRI selection was performed in 34 patients; CTP in 139 patients. Baseline National Institutes of Health Stroke Scale score was 17 in both groups. Target mismatch profile was present in 95% (MRI) versus 83% (CTP). A higher percentage of the MRI group was transferred from an outside hospital ( P =0.02), and therefore, the time from stroke onset to randomization was longer in the MRI group ( P =0.003). Time from emergency room arrival to randomization did not differ in CTP versus MRI-selected patients. Baseline ischemic core volumes were similar in both groups. Reperfusion rates (>90%/TICI [Thrombolysis in Cerebral Infarction] score 3) did not differ in the stentriever-treated patients in the MRI versus CTP groups. The primary efficacy analysis (90-day mRS score) demonstrated a statistically significant benefit in both subgroups (MRI, P =0.02; CTP, P =0.01). Infarct growth was reduced in the stentriever-treated group in both MRI and CTP groups. Time to randomization was significantly longer in MRI-selected patients; however, site arrival to randomization times were not prolonged, and the benefits of endovascular therapy were similar. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01657461. © 2017 American Heart Association, Inc.

Cost-Effectiveness of Endovascular Stroke Therapy: A Patient Subgroup Analysis From a US Healthcare Perspective.

PubMed

Kunz, Wolfgang G; Hunink, M G Myriam; Sommer, Wieland H; Beyer, Sebastian E; Meinel, Felix G; Dorn, Franziska; Wirth, Stefan; Reiser, Maximilian F; Ertl-Wagner, Birgit; Thierfelder, Kolja M

2016-11-01

Endovascular therapy in addition to standard care (EVT+SC) has been demonstrated to be more effective than SC in acute ischemic large vessel occlusion stroke. Our aim was to determine the cost-effectiveness of EVT+SC depending on patients' initial National Institutes of Health Stroke Scale (NIHSS) score, time from symptom onset, Alberta Stroke Program Early CT Score (ASPECTS), and occlusion location. A decision model based on Markov simulations estimated lifetime costs and quality-adjusted life years (QALYs) associated with both strategies applied in a US setting. Model input parameters were obtained from the literature, including recently pooled outcome data of 5 randomized controlled trials (ESCAPE [Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke], EXTEND-IA [Extending the Time for Thrombolysis in Emergency Neurological Deficits-Intra-Arterial], MR CLEAN [Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands], REVASCAT [Randomized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting Within 8 Hours of Symptom Onset], and SWIFT PRIME [Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment]). Probabilistic sensitivity analysis was performed to estimate uncertainty of the model results. Net monetary benefits, incremental costs, incremental effectiveness, and incremental cost-effectiveness ratios were derived from the probabilistic sensitivity analysis. The willingness-to-pay was set to $50 000/QALY. Overall, EVT+SC was cost-effective compared with SC (incremental cost: $4938, incremental effectiveness: 1.59 QALYs, and incremental cost-effectiveness ratio: $3110/QALY) in 100% of simulations. In all patient subgroups, EVT+SC led to gained QALYs (range: 0.47-2.12), and mean incremental cost-effectiveness ratios were considered cost-effective. However, subgroups with ASPECTS ≤5 or with M2 occlusions showed considerably higher incremental cost-effectiveness ratios ($14 273/QALY and $28 812/QALY, respectively) and only reached suboptimal acceptability in the probabilistic sensitivity analysis (75.5% and 59.4%, respectively). All other subgroups had acceptability rates of 90% to 100%. EVT+SC is cost-effective in most subgroups. In patients with ASPECTS ≤5 or with M2 occlusions, cost-effectiveness remains uncertain based on current data. © 2016 American Heart Association, Inc.

Retrievable Stent-Assisted Coiling Technique Using a Solitaire Stent: Treatment of Pancreaticoduodenal Artery Aneurysm Associated With Celiac Artery Occlusion.

PubMed

Sanal, Bekir; Nas, Omer Fatih; Hacikurt, Kadir; Hakyemez, Bahattin; Erdogan, Cuneyt

2016-02-01

True aneurysm of pancreaticoduodenal arcade (PDA) is usually accompanied by stenosis or occlusion of celiac trunk (CeT). The up-to-date and first choice treatment modality of PDA aneurysm is the endovascular approach in nearly all cases except few selected ones necessitating surgery. The main approach in endovascular treatment is embolization of the aneurysm by preserving the parent artery. A case with concomitant CeT occlusion and PDA aneurysm was treated with coil embolization by preserving inferior pancreaticoduodenal artery with retrievable Solitaire(®) stent. In our knowledge, this is the first case with PDA aneurysm treated with this technique. © The Author(s) 2016.

Wear and microhardness of different resin composite materials.

PubMed

Say, Esra Can; Civelek, Arzu; Nobecourt, Alain; Ersoy, Mustafa; Guleryuz, Canan

2003-01-01

This study determined the three-body abrasive wear resistance of two packable composites (P-60; Solitaire 2), an ion-releasing composite (Ariston AT), a hybrid composite (Tetric Ceram) and an ormocer (Admira). The study also looked at the correlation between wear resistance and hardness of the composites. Three-body wear testing was performed using an ACTA wear machine with 15 N contact force using millet seed as the third body. Wear depth (microm) was measured by profilometry after 200,000 cycles. The hardness test was performed using a digital microhardness tester (load: 500 g; dwell time: 15 seconds). The data were analyzed by using Kruskal Wallis (p < 0.05). There were statistically significant differences among the three body abrasive wear of the composites. The ranking from least to most were as follows: Filtek P-60 < Solitaire 2 < Ariston AT < Tetric Ceram < Admira. Filtek P-60 showed the highest microhardness value. No other significant differences in hardness were observed among the different resin composites (P-60 > AristonAT = Tetric Ceram = Solitaire 2 = Admira). The results of this study indicate that there are significant differences in the wear resistance of the resin composites. The correlation between hardness and wear was significant with a correlation coefficient of r:-0.91. A significant negative correlation exists between hardness and three-body wear of resin composites.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wenger, Katharina, E-mail: kwenger@stud.uni-frankfurt.de; Nagl, Frank, E-mail: fnagl@acandis.com; Wagner, Marlies, E-mail: Marlies.Wagner@kgu.de

In vitro experiments were performed to evaluate the efficacy of mechanical intracranial thrombectomy comparing the newly developed Aperio stent retriever and standard devices for stroke treatment. The Aperio (A), with an increased working length of 4 cm and a special cell design for capturing and withholding clots, was compared to three benchmark devices: the Solitaire retrievable stent (B), the Merci X6 (C), and the Merci L5 retriever (D). In a vascular glass model with pulsatile flow, reminiscent of the M1 segment of the middle cerebral artery, we repeatedly induced occlusion by generating thrombi via a modified Chandler loop system. Themore » numbers of recanalization attempts, peripheral embolizations, and recanalizations at the site of occlusion were recorded during 10 retrieval experiments with each device. Eleven devices were able to remove the blood clots from the occluded branch. In 34 of 40 experiments, restoration of flow was obtained in 1-3 attempts. The main differences between the study devices were observed in terms of clot withholding and fragmentation during retrieval. Although there was only one fragmentation recorded for device A, disengagement of the whole clot or peripheral embolization of fragments occurred more frequently (5-7 times) with devices B, C, and D. In a vascular model, the design of device A was best at capturing and withholding thrombi during retrieval. Further study will be necessary to see whether this holds true in clinical applications.« less

Endovascular vs medical management of acute ischemic stroke

PubMed Central

Ding, Dale; Starke, Robert M.; Mehndiratta, Prachi; Crowley, R. Webster; Liu, Kenneth C.; Southerland, Andrew M.; Worrall, Bradford B.

2015-01-01

Objective: To compare the outcomes between endovascular and medical management of acute ischemic stroke in recent randomized controlled trials (RCT). Methods: A systematic literature review was performed, and multicenter, prospective RCTs published from January 1, 2013, to May 1, 2015, directly comparing endovascular therapy to medical management for patients with acute ischemic stroke were included. Meta-analyses of modified Rankin Scale (mRS) and mortality at 90 days and symptomatic intracranial hemorrhage (sICH) for endovascular therapy and medical management were performed. Results: Eight multicenter, prospective RCTs (Interventional Management of Stroke [IMS] III, Local Versus Systemic Thrombolysis for Acute Ischemic Stroke [SYNTHESIS] Expansion, Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy [MR RESCUE], Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands [MR CLEAN], Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness [ESCAPE], Extending the Time for Thrombolysis in Emergency Neurological Deficits–Intra-Arterial [EXTEND-IA], Solitaire With the Intention For Thrombectomy as Primary Endovascular Treatment [SWIFT PRIME], and Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours [REVASCAT]) comprising 2,423 patients were included. Meta-analysis of pooled data demonstrated functional independence (mRS 0–2) at 90 days in favor of endovascular therapy (odds ratio [OR] = 1.71; p = 0.005). Subgroup analysis of the 6 trials with large vessel occlusion (LVO) criteria also demonstrated functional independence at 90 days in favor of endovascular therapy (OR = 2.23; p < 0.00001). Subgroup analysis of the 5 trials that primarily utilized stent retriever devices (≥70%) in the intervention arm demonstrated functional independence at 90 days in favor of endovascular therapy (OR = 2.39; p < 0.00001). No difference was found for mortality at 90 days and sICH between endovascular therapy and medical management in all analyses and subgroup analyses. Conclusions: This meta-analysis provides strong evidence that endovascular intervention combined with medical management, including IV tissue plasminogen activator for eligible patients, improves the outcomes of appropriately selected patients with acute ischemic stroke in the setting of LVO. PMID:26537058

The elusive illusion: Do children (Homo sapiens) and capuchin monkeys (Cebus apella) see the Solitaire illusion?

PubMed

Parrish, Audrey E; Agrillo, Christian; Perdue, Bonnie M; Beran, Michael J

2016-02-01

One approach to gaining a better understanding of how we perceive the world is to assess the errors that human and nonhuman animals make in perceptual processing. Developmental and comparative perspectives can contribute to identifying the mechanisms that underlie systematic perceptual errors often referred to as perceptual illusions. In the visual domain, some illusions appear to remain constant across the lifespan, whereas others change with age. From a comparative perspective, many of the illusions observed in humans appear to be shared with nonhuman primates. Numerosity illusions are a subset of visual illusions and occur when the spatial arrangement of stimuli within a set influences the perception of quantity. Previous research has found one such illusion that readily occurs in human adults, the Solitaire illusion. This illusion appears to be less robust in two monkey species, rhesus macaques and capuchin monkeys. We attempted to clarify the ontogeny of this illusion from a developmental and comparative perspective by testing human children and task-naïve capuchin monkeys in a computerized quantity judgment task. The overall performance of the monkeys suggested that they perceived the numerosity illusion, although there were large differences among individuals. Younger children performed similarly to the monkeys, whereas older children more consistently perceived the illusion. These findings suggest that human-unique perceptual experiences with the world might play an important role in the emergence of the Solitaire illusion in human adults, although other factors also may contribute. Copyright © 2015 Elsevier Inc. All rights reserved.

Stent-Assisted Coil Embolization of a Mycotic Renal Artery Aneurysm by Use of a Self-Expanding Neurointerventional Stent

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rabellino, Martin, E-mail: jmrabellino@hotmail.com; Garcia-Nielsen, Luis, E-mail: luisgarcia@hospiten.es; Zander, Tobias, E-mail: tobiaszander@hospiten.es

2011-02-15

Mycotic aneurysms are uncommon, especially those located in visceral arteries. We present a case of a patient with two visceral mycotic aneurysms due to bacterial endocarditis, one located in right upper pole renal artery and the second in the splenic artery. Both aneurysms were treated as endovascular embolization using microcoils. In the aneurysm located at the renal artery, the technique of stent-assisted coils embolization was preferred to avoid coils migration due to its wide neck. The stent used was the Solitaire AB, which was designed for the treatment of intracranial aneurysms and was used recently in acute stroke as amore » mechanical thrombectomy device. Complete embolization of the aneurysm was achieved, preserving all the arterial branches without nephrogram defects in the final angiogram.« less

Value-based procurement of medical devices: Application to devices for mechanical thrombectomy in ischemic stroke.

PubMed

Trippoli, Sabrina; Caccese, Erminia; Marinai, Claudio; Messori, Andrea

2018-03-01

In the acute ischemic stroke, endovascular devices have shown promising clinical results and are also likely to represent value for money, as several modeling studies have shown. Pharmacoeconomic evaluations in this field, however, have little impact on the procurement of these devices. The present study explored how complex pharmacoeconomic models that evaluate effectiveness and cost can be incorporated into the in-hospital procurement of thrombectomy devices. As regards clinical modeling, we extracted outcomes at three months from randomized trials conducted for four thrombectomy devices, and we projected long-term results using standard Markov modeling. In estimating QALYs, the same model was run for the four devices. As regards economic modeling, we firstly estimated for each device the net monetary benefit (NMB) per patient (threshold = $60,000 per QALY); then, we simulated a competitive tender across the four products by determining the tender-based score (on a 0-to-100 scale). Prices of individual devices were obtained from manufacturers. Extensive sensitivity testing was applied to our analyses. For the four devices (Solitaire, Trevo, Penumbra, Solumbra), QALYs were 1.86, 1.52, 1,79, 1.35, NMB was $101,824, $83,546, $101,923, $69,440, and tender-based scores were 99.70, 43.43, 100, 0, respectively. Sensitivity analysis confirmed findings from base-case. Our results indicate that, in the field of thrombectomy devices, incorporating the typical tools of cost-effectiveness into the processes of tenders and procurement is feasible. Bridging the methodology of cost-effectiveness with the every-day practice of in-hospital procurement can contribute to maximizing the health returns that are generated by in-hospital expenditures for medical devices. Copyright © 2018 Elsevier B.V. All rights reserved.

Effect of endovascular reperfusion in relation to site of arterial occlusion.

PubMed

Lemmens, Robin; Hamilton, Scott A; Liebeskind, David S; Tomsick, Tom A; Demchuk, Andrew M; Nogueira, Raul G; Marks, Michael P; Jahan, Reza; Gralla, Jan; Yoo, Albert J; Yeatts, Sharon D; Palesch, Yuko Y; Saver, Jeffrey L; Pereira, Vitor M; Broderick, Joseph P; Albers, Gregory W; Lansberg, Maarten G

2016-02-23

To assess whether the association between reperfusion and improved clinical outcomes after stroke differs depending on the site of the arterial occlusive lesion (AOL). We pooled data from Solitaire With the Intention for Thrombectomy (SWIFT), Solitaire FR Thrombectomy for Acute Revascularisation (STAR), Diffusion and Perfusion Imaging Evaluation for Understanding Stroke Evolution Study 2 (DEFUSE 2), and Interventional Management of Stroke Trial (IMS III) to compare the strength of the associations between reperfusion and clinical outcomes in patients with internal carotid artery (ICA), proximal middle cerebral artery (MCA) (M1), and distal MCA (M2/3/4) occlusions. Among 710 included patients, the site of the AOL was the ICA in 161, the proximal MCA in 389, and the distal MCA in 160 patients (M2 = 131, M3 = 23, and M4 = 6). Reperfusion was associated with an increase in the rate of good functional outcome (modified Rankin Scale [mRS] score 0-2) in patients with ICA (odds ratio [OR] 3.5, 95% confidence interval [CI] 1.7-7.2) and proximal MCA occlusions (OR 6.2, 95% CI 3.8-10.2), but not in patients with distal MCA occlusions (OR 1.4, 95% CI 0.8-2.6). Among patients with M2 occlusions, a subset of the distal MCA cohort, reperfusion was associated with excellent functional outcome (mRS 0-1; OR 2.2, 95% CI 1.0-4.7). The association between endovascular reperfusion and better clinical outcomes is more profound in patients with ICA and proximal MCA occlusions compared to patients with distal MCA occlusions. Because there are limited data from randomized controlled trials on the effect of endovascular therapy in patients with distal MCA occlusions, these results underscore the need for inclusion of this subgroup in future endovascular therapy trials. © 2016 American Academy of Neurology.

Topics

ERIC Educational Resources Information Center

Mathematics Teaching, 1973

1973-01-01

This column includes the description of a game involving addition and subtraction of integers represented by colored bricks, a general formula for an enlargement in the Cartesian plane, an analysis of the possibilities for certain games of board Solitaire, and a BASIC program for a recreational mathematics problem. (DT)

Discovery of New Hydrothermal Activity and Chemosynthetic Fauna on the Central Indian Ridge at 18°–20°S

PubMed Central

Nakamura, Kentaro; Watanabe, Hiromi; Miyazaki, Junichi; Takai, Ken; Kawagucci, Shinsuke; Noguchi, Takuro; Nemoto, Suguru; Watsuji, Tomo-o; Matsuzaki, Takuya; Shibuya, Takazo; Okamura, Kei; Mochizuki, Masashi; Orihashi, Yuji; Ura, Tamaki; Asada, Akira; Marie, Daniel; Koonjul, Meera; Singh, Manvendra; Beedessee, Girish; Bhikajee, Mitrasen; Tamaki, Kensaku

2012-01-01

Indian Ocean hydrothermal vents are believed to represent a novel biogeographic province, and are host to many novel genera and families of animals, potentially indigenous to Indian Ocean hydrothermal systems. In particular, since its discovery in 2001, much attention has been paid to a so-called ‘scaly-foot’ gastropod because of its unique iron-sulfide-coated dermal sclerites and the chemosynthetic symbioses in its various tissues. Despite increasing interest in the faunal assemblages at Indian Ocean hydrothermal vents, only two hydrothermal vent fields have been investigated in the Indian Ocean. Here we report two newly discovered hydrothermal vent fields, the Dodo and Solitaire fields, which are located in the Central Indian Ridge (CIR) segments 16 and 15, respectively. Chemosynthetic faunal communities at the Dodo field are emaciated in size and composition. In contrast, at the Solitaire field, we observed faunal communities that potentially contained almost all genera found at CIR hydrothermal environments to date, and even identified previously unreported taxa. Moreover, a new morphotype of ‘scaly-foot’ gastropod has been found at the Solitaire field. The newly discovered ‘scaly-foot’ gastropod has similar morphological and anatomical features to the previously reported type that inhabits the Kairei field, and both types of ‘scaly-foot’ gastropods genetically belong to the same species according to analyses of their COI gene and nuclear SSU rRNA gene sequences. However, the new morphotype completely lacks an iron-sulfide coating on the sclerites, which had been believed to be a novel feature restricted to ‘scaly-foot’ gastropods. Our new findings at the two newly discovered hydrothermal vent sites provide important insights into the biodiversity and biogeography of vent-endemic ecosystems in the Indian Ocean. PMID:22431990

Toxicity testing of restorative dental materials using brine shrimp larvae (Artemia salina).

PubMed

Milhem, Manar M; Al-Hiyasat, Ahmad S; Darmani, Homa

2008-01-01

This study investigated the effect of extracts of different composites, glass ionomer cement (GIC)s and compomers on the viability of brine shrimp larvae. Ethanolic extracts of four dental composites (Z-100; Solitaire 2; Filtek P60 and Synergy), a conventional GIC (Ketac-Fil), a resin-modified glass ionomer cement (Vitremer), two compomers (F2000; Dyract AP), and a flowable compomer (Dyract Flow) were prepared from each material. Following evaporation of the ethanol, the extracts were resuspended in distilled water, which was then used to test the effects on the viability of brine shrimp larvae. For the composites, the extract of Synergy was the least toxic (88% viability) followed by the extracts of Solitaire 2, Z100 and P60 (75%, 67.5% and 50% viability, respectively). One-way ANOVA revealed highly significant differences between the resin composite materials (p<0.001). Follow-up comparison between the composite groups by Tukey's pairwise multiple-comparison test (alpha =0.05) showed that the extract of Synergy was significantly less toxic than the extracts of all the other materials except that of Solitaire 2. The compomers showed 100% lethality, while the percentage of viable larvae for the extracts of Ketac-Fil, and Vitremer were 32.3%, and 37.0%, respectively. One-way ANOVA revealed highly significant differences between the groups of materials (p<0.001). Follow-up comparison between the groups by Tukey's test (alpha = 0.05) showed that the toxic effect of the extracts of the compomers were significantly greater than that of Ketac-Fil, and Vitremer. The differences in the toxic effects of Vitremer and Ketac-Fil were not statistically significant. In conclusion, the toxicity of composite materials varied according to their chemical composition. Compomers were the most lethal materials to brine shrimp larvae followed by GICs and then composites.

Chemical Solitaire

ERIC Educational Resources Information Center

Philippof, Joanna; Seraphin, Kanesa Duncan; Seki, Jennifer; Kaupp, Lauren

2015-01-01

The periodic table does more than provide information about the elements. The periodic table also helps us make predictions about how the elements behave. Understanding the atomic structure of matter and periodic properties of the elements, as shown in the periodic table, is fundamental to many scientific disciplines. Unfortunately, high school…

Chemical Mahjong

ERIC Educational Resources Information Center

Cossairt, Travis J.; Grubbs, W. Tandy

2011-01-01

An open-access, Web-based mnemonic game is described whereby introductory chemistry knowledge is tested using mahjong solitaire game play. Several tile sets and board layouts are included that are themed upon different chemical topics. Introductory tile sets can be selected that prompt the player to match element names to symbols and metric…

Editorial: What Use Is Astronomy?

NASA Astrophysics Data System (ADS)

Percy, J. R.

2018-06-01

Why do people such as AAVSOers observe or analyze variable stars? A few readers may simply say that observing is a relaxing, outdoor pastime, like fishing, and that analysis is a way to keep the mind occupied, like solitaire. But most will say "to advance the science of astronomy." But what use is astronomy?

The Math Explorer: Games and Activities for Middle School Youth Groups.

ERIC Educational Resources Information Center

Murphy, Pat; Lambertson, Lori; Tesler, Pearl

This book offers games and mathematics activities using a hands-on approach for middle school students and features games, puzzles, experiments, and projects. Contents include: (1) "Boxed In!"; (2) "Oddball"; (3) "Pig"; (4) "Madagascar Solitaire"; (5) "Fantastic Four"; (6) "Eratosthenes' Sieve"; (7) "Hopping Hundred"; (8) "Tic-Tac-Toe Times"; (9)…

TOXICITY TESTING OF RESTORATIVE DENTAL MATERIALS USING BRINE SHRIMP LARVAE (ARTEMIA SALINA)

PubMed Central

Milhem, Manar M.; Al-Hiyasat, Ahmad S.; Darmani, Homa

2008-01-01

This study investigated the effect of extracts of different composites, glass ionomer cement (GIC)s and compomers on the viability of brine shrimp larvae. Ethanolic extracts of four dental composites (Z-100; Solitaire 2; Filtek P60 and Synergy), a conventional GIC (Ketac-Fil), a resin-modified glass ionomer cement (Vitremer), two compomers (F2000; Dyract AP), and a flowable compomer (Dyract Flow) were prepared from each material. Following evaporation of the ethanol, the extracts were resuspended in distilled water, which was then used to test the effects on the viability of brine shrimp larvae. For the composites, the extract of Synergy was the least toxic (88% viability) followed by the extracts of Solitaire 2, Z100 and P60 (75%, 67.5% and 50% viability, respectively). One-way ANOVA revealed highly significant differences between the resin composite materials (p<0.001). Follow-up comparison between the composite groups by Tukey's pairwise multiple-comparison test (α =0.05) showed that the extract of Synergy was significantly less toxic than the extracts of all the other materials except that of Solitaire 2. The compomers showed 100% lethality, while the percentage of viable larvae for the extracts of Ketac-Fil, and Vitremer were 32.3%, and 37.0%, respectively. One-way ANOVA revealed highly significant differences between the groups of materials (p<0.001). Follow-up comparison between the groups by Tukey's test (α = 0.05) showed that the toxic effect of the extracts of the compomers were significantly greater than that of Ketac-Fil, and Vitremer. The differences in the toxic effects of Vitremer and Ketac-Fil were not statistically significant. In conclusion, the toxicity of composite materials varied according to their chemical composition. Compomers were the most lethal materials to brine shrimp larvae followed by GICs and then composites. PMID:19089264

A new screening test for toxicity testing of dental materials.

PubMed

Pelka, M; Danzl, C; Distler, W; Petschelt, A

2000-07-01

The development of a micro plate assay for cytotoxicity testing of dental materials based on a bioassay using brine shrimp larvae (artemia salina) as sensitive organisms. Brine shrimp larvae are commonly used for cytotoxicity assays in pharmacology. These larvae are sensitive to toxic substances. The ratio between dead larvae (no motility) and living larvae (high motility) in comparison to a control without any toxic substances is used to estimate the toxicity of the test solutions. The test materials (Arabesk((R)), Solitaire((R)), Pertac((R)) II, Tetric((R)), Herculite((R)) and the compomer materials Dyract((R)), Hytac((R)), Compoglass((R))) were polymerized and consecutively milled. After incubation of 1g in 4ml distilled water at 37 degrees C for 48h, the solid materials were separated by centrifugation. The solutions were equibrilated with NaCl to a salt content of 25g/l. Aliquots of 200microl were distributed in eight micro wells and 50microl of a artemia salina containing (n=8-14) solution were added to each well. As controls eight wells with 250microl salt solution containing a comparable number of brine shrimp were used. At baseline, after 2, 5, 24 and 48h, the dead shrimp were counted using a stereo microscope. Finally all shrimps were sacrificed using Na-acid (5%) and counted to get the number of shrimps per well. All compomers and Solitaire caused 100% brine shrimp lethality after 24h and showed significantly (p<0.01, signed rank test) higher toxicities than the remaining composites. With the exception of Pertac II, all composites showed significantly higher toxic values than the control. Pertac II did not show any differences from the controls used. This new technique has some advantages for toxicity testing of restorative materials, because it can quickly be carried out at low costs. The disadvantage is the high quantity of material used and the low sensitivity.

Cost-Effectiveness of Solitaire Stent Retriever Thrombectomy for Acute Ischemic Stroke: Results From the SWIFT-PRIME Trial (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke).

PubMed

Shireman, Theresa I; Wang, Kaijun; Saver, Jeffrey L; Goyal, Mayank; Bonafé, Alain; Diener, Hans-Christoph; Levy, Elad I; Pereira, Vitor M; Albers, Gregory W; Cognard, Christophe; Hacke, Werner; Jansen, Olav; Jovin, Tudor G; Mattle, Heinrich P; Nogueira, Raul G; Siddiqui, Adnan H; Yavagal, Dileep R; Devlin, Thomas G; Lopes, Demetrius K; Reddy, Vivek K; du Mesnil de Rochemont, Richard; Jahan, Reza; Vilain, Katherine A; House, John; Lee, Jin-Moo; Cohen, David J

2017-02-01

Clinical trials have demonstrated improved 90-day outcomes for patients with acute ischemic stroke treated with stent retriever thrombectomy plus tissue-type plasminogen activator (SST+tPA) compared with tPA. Previous studies suggested that this strategy may be cost-effective, but models were derived from pooled data and older assumptions. In this prospective economic substudy conducted alongside the SWIFT-PRIME trial (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke), in-trial costs were measured for patients using detailed medical resource utilization and hospital billing data. Utility weights were assessed at 30 and 90 days using the EuroQol-5 dimension questionnaire. Post-trial costs and life-expectancy were estimated for each surviving patient using a model based on trial data and inputs derived from a contemporary cohort of ischemic stroke survivors. Index hospitalization costs were $17 183 per patient higher for SST+tPA than for tPA ($45 761 versus $28 578; P<0.001), driven by initial procedure costs. Between discharge and 90 days, costs were $4904 per patient lower for SST+tPA than for tPA ($11 270 versus $16 174; P=0.014); total 90-day costs remained higher with SST+tPA ($57 031 versus $44 752; P<0.001). Higher utility values for SST+tPA led to higher in-trial quality-adjusted life years (0.131 versus 0.105; P=0.005). In lifetime projections, SST+tPA was associated with substantial gains in quality-adjusted life years (6.79 versus 5.05), cost savings of $23 203 per patient and was economically dominant when compared with tPA in 90% of bootstrap replicates. Among patients with acute ischemic stroke enrolled in the SWIFT-PRIME trial, SST increased initial treatment costs, but was projected to improve quality-adjusted life-expectancy and reduce healthcare costs over a lifetime horizon compared with tPA. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01657461. © 2016 American Heart Association, Inc.

The volumetric fraction of inorganic particles and the flexural strength of composites for posterior teeth.

PubMed

Adabo, Gelson Luis; dos Santos Cruz, Carlos Alberto; Fonseca, Renata Garcia; Vaz, Luís Geraldo

2003-07-01

To evaluate the content of inorganic particles and the flexural strength of new condensable composites for posterior teeth in comparison to hybrid conventional composites. The determination of the content of inorganic particles was performed by mass weighing of a polymerized composite before and after the elimination of the organic phase. The volumetric particle content was determined by a practical method based on Archimedes' principle, which calculates the volume of the composite and their particles by differential mass measured in the air and in water. The flexural strength of three points was evaluated according to the norm ISO 4049:1988. The results showed the following filler content: Alert, 67.26%; Z-100, 65.27%; Filtek P 60, 62.34%; Ariston pHc, 64.07%; Tetric Ceram, 57.22%; Definite, 54.42%; Solitaire, 47.76%. In the flexural strength test, the materials presented the following decreasing order of resistance: Filtek P 60 (170.02 MPa)>Z-100 (151.34 MPa)>Tetric Ceram (126.14 MPa)=Alert (124.89 MPa)>Ariston pHc (102.00 MPa)=Definite (93.63 MPa)>Solitaire (56.71 MPa). New condensable composites for posterior teeth present a concentration of inorganic particles similar to those of hybrid composites but do not necessarily present higher flexural strength.

Hyperperfusion syndrome after MCA embolectomy – a rare complication?

PubMed Central

Backhaus, Roland; Boy, Sandra; Fuchs, Kornelius; Ulrich, Bogdahn; Schuierer, Gerhard; Schlachetzki, Felix

2013-01-01

Patient: Female, 78 Final Diagnosis: Cerebral hyperperfusion syndrome Symptoms: — Medication: — Clinical Procedure: Endovascular embolectomy Specialty: Neurology Objective: Unknown ethiology Background: Cerebral hyperperfusion syndrome (cHS) is a well known but rare complication after carotid endarterectomy, carotid angioplasty with stenting, and stenting of intracranial arterial stenosis. The clinical presentation may vary from acute onset of focal oedema (stroke-like presentation) and intracerbral hemorrhage to delayed (>24h hours after the procedure) presentation with seizures, focal motor weakness, or late intracerebral hemorrhage. The incidence of cHS after carotid endarterectomy ranges from 0–3% and defined as an increase of the ipsilateral cerebral blood flow up to 40% over baseline in ultrasound. Case Report: We present a case of a 78-year-old woman with an acute ischemic stroke due to left side middle cerebral artery territory with right sided hemiparesis and aphasia (NIHSS 16). After systemic thrombolysis embolectomy using a retractable stent (Solitaire® device) was performed and resulted in complete and successful recanalization of MCA including its branches about 210 minutes after symptom onset but, partial dislocation of thrombotic material into the anterior cerebral artery (ACA). Conclusions: Cerebral hyperperfusion syndrome should be considered in patients with clinical deterioration after successful recanalisation and the early diagnosis and treatment may be important for neurological outcome after endovascular embolectomy PMID:24340127

Surface geometry of three packable and one hybrid composite after polishing.

PubMed

Jung, Martin; Bruegger, Hilka; Klimek, Joachim

2003-01-01

This study evaluated the surface quality of four composite materials after polishing with six different polishing techniques. Eighty specimens were made using three packable composites (Definite/Degussa, SureFil/ Dentsply and Solitaire/Heraeus-Kulzer) and one hybrid composite (Herculite XRV/Kerr). Five specimens of each material were polished using flexible Sof-Lex discs. The remaining 75 specimens of each composite were prepared using three finishing protocols: a single 30 microm diamond (n = 25), two finishing diamonds (30/20 microm; n = 25) and a 30 microm diamond followed by a tungsten carbide finishing bur (n = 25). Final polishing of each of the three finishing groups was accomplished with SuperBuff, Diafix-oral, OneGloss, Astropol and HaWe Composite Polishers (n = 5, each). Surface roughness was evaluated quantitatively by laser-stylus profilometry. Average roughness (R(a)) was calculated; statistical analysis of the data was performed with two-way ANOVA and Scheffé post-hoc tests. The polished surfaces were examined qualitatively by SEM. The results showed significant effects on surface roughness from the different composites (p = 0.011) and polishing systems (p < 0.001). After polishing, the Solitaire surfaces (R(a) = 0.72 microm) were smoother than Definite (R(a) = 0.87 microm) and SureFil (R(a) = 0.89 microm) and significantly smoother than Herculite (R(a) = 0.92 microm; p = 0.011). Three of the polishing methods (SuperBuff, Diafix-oral and Astropol) achieved lower R(a)-values than Sof-Lex discs. The polishing quality of the one-step systems SuperBuff and Diafix-oral was strongly affected by the initial finishing protocol.

Wear resistance of packable resin composites after simulated toothbrushing test.

PubMed

Wang, Linda; Garcia, Fernanda Cristina Pimentel; Amarante de Araújo, Paulo; Franco, Eduardo Batista; Mondelli, Rafael Francisco Lia

2004-01-01

The purpose of this study was to determine the wear resistance of five different packable composites versus two different composite controls using a laboratory toothbrushing simulation test. Twelve samples measuring 5 mm in diameter and 3 mm thick were prepared from the following resin composites: Packable resin composites SureFil (Dentsply Ind. Com. Ltda, Petrópolis, Rio de Janeiro, Brazil), Alert (Jeneric Pentron Incorporated, Wallingford, CT, USA), Filtek P60 (3M ESPE Dental Products, St. Paul, MN, USA), Prodigy Condensable (sds Kerr, Orange CA, USA), Solitaire (Heraeus Kulzer GmbH, Wehrheim, Germany), and control resin composites Z100 Restorative (3M ESPE) and Silux Plus (3M ESPE). Finishing and polishing were conducted with Sof-Lex disks (3M ESPE), and baseline weight (grams) and surface roughness (measured with Hommel Tester T 1000, Hommelwerke, GmbH, Alte Tuttinger Strebe 20. D-7730 VS-Schwenningen, Germany) were recorded. Specimens were aged for 2 weeks until they reached a weight that remained constant for 5 consecutive days, and then were subjected to 100,000 cycles of brushing (representative of 4.2 yr) using a toothbrushing testing machine. Toothbrush heads with soft bristle tips (Colgate Classic, Colgate-Palmolive Co., Osasco, São Paulo, Brazil) with dentifrice suspension (Colgate MFP, Colgate-Palmolive Co.) in deionized water were used under a 200 g load. Changes in weight and surface roughness were determined after toothbrushing cycles. Significant differences of weight loss and surface roughness were found (paired t-test, p < .05). Weight loss percentage (mean [SD]) ranged from 0.38 to 1.69% (analysis of variance and Tukey's least significant difference, p < .05); the weight loss of the materials ranked from least to most as follows: SureFil (0.38 [0.56]), Alert (0.52 [0.18]), Z100 (1.16 [0.27]), Filtek P60 (1.31 [0.17]), Solitaire (1.51 [0.45]), Prodigy Condensable (1.55 [0.471), and Silux Plus (1.69 [0.66]). Regarding surface roughness, Prodigy Condensable (0.19 [0.08]), Solitaire (0.28 [0.06]), and Z100 (0.30 [0.07]) became less rough after toothbrushing, whereas all the others were rendered rougher: Alert (0.49 [0.29]), Filtek P60 (0.28 [0.08]), Silux Plus (0.39 [0.091), and SureFil (0.81 [0.32]). SureFil and Alert were statistically more resistant to wear (less weight loss) than were the other materials. SureFil became significantly rougher than did all the others. Overal, packable resin composites are unlikely to show superior wear resistance with regard to weight loss and surface roughness compared with current resin composites also indicated for posterior restorations.

77 FR 35747 - Highway Safety Programs; Conforming Products List of Evidential Breath Alcohol Measurement Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-14

...-0061] Highway Safety Programs; Conforming Products List of Evidential Breath Alcohol Measurement... Evidential Breath Alcohol Measurement Devices dated, September 17, 1993 (58 FR 48705). DATES: Effective Date... Safety Administration (NHTSA) published the Standards for Devices to Measure Breath Alcohol (38 FR 30459...

Time dependence of composite shrinkage using halogen and LED light curing.

PubMed

Uhl, Alexander; Mills, Robin W; Rzanny, Angelika E; Jandt, Klaus D

2005-03-01

The polymerization shrinkage of light cured dental composites presents the major drawback for these aesthetically adaptable restorative materials. LED based light curing technology has recently become commercially available. Therefore, the aim of the present study was to investigate if there was a statistically significant difference in linear and volumetric composite shrinkage strain if a LED LCU is used for the light curing process rather than a conventional halogen LCU. The volumetric shrinkage strain was determined using the Archimedes buoyancy principle after 5, 10, 20, 40 s of light curing and after 120 s following the 40 s light curing time period. The linear shrinkage strain was determined with a dynamic mechanical analyzer for the composites Z100, Spectrum, Solitaire2 and Definite polymerized with the LCUs Trilight (halogen), Freelight I (LED) and LED63 (LED LCU prototype). The changes in irradiance and spectra of the LCUs were measured after 0, 312 and 360 min of duty time. In general there was no considerable difference in shrinkage of the composites Z100, Spectrum or Solitaire2 when the LED63 was used instead of the Trilight. There was, however, a statistically significant difference in shrinkage strain when the composite Definite was polymerized with the LED63 instead of the Trilight. The spectrum of the Trilight changed during the experiment considerably whereas the LED63 showed an almost constant light output. The Freelight I dropped considerably in irradiance and had to be withdrawn from the study because of technical problems. The composites containing only the photoinitiator camphorquinone showed similar shrinkage strain behaviour when a LED or halogen LCU is used for the polymerization. The irradiance of some LED LCUs can also decrease over time and should therefore be checked on a regular basis.

Conway's Game of Life: Early Personal Recollections

NASA Astrophysics Data System (ADS)

Wainwright, Robert

When the October 1970 issue of Scientific American arrived, I had no idea the extent to which Martin Gardner's article in that issue would affect my life. As long as I can remember, my custom would be to seek out the Mathematical Games column in search for Gardner's latest topic with the usual reader challenges. My first reaction to that particular article introducing a new pastime titled "The fantastic combinations of John Conway's new solitaire game 'life''' was only mildly interesting. A couple of days later, still curious about the outcome of random patterns, I located an old checkerboard and a small jarful of pennies to investigate this new game.

77 FR 35745 - Highway Safety Programs; Conforming Products List of Screening Devices To Measure Alcohol in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-14

..., battery powered device with a semiconductor sensor. (2) Alcohol Countermeasure Systems Corp., submitted...-0062] Highway Safety Programs; Conforming Products List of Screening Devices To Measure Alcohol in... Screening Devices to Measure Alcohol in Bodily Fluids dated, March 31, 2008 (73 FR 16956). DATES: Effective...

77 FR 1083 - Certain Portable Electronic Devices and Related Software; Determination Not To Review Initial...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-09

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-797] Certain Portable Electronic Devices and Related Software; Determination Not To Review Initial Determination Granting Motion To Amend the... the United States after importation of certain portable electronic devices and related software. 76 FR...

Transarterial treatment of direct carotico-cavernous fistulas with coils and Onyx.

PubMed

Ramalingaiah, Arvinda Hanumanthapura; Prasad, Chandrajit; Sabharwal, Paramveer Singh; Saini, Jitender; Pandey, Paritosh

2013-10-01

The purpose of this study was to evaluate the role of combination of liquid embolic agent ethylene vinyl alcohol copolymer (Onyx) and detachable coils in the treatment of direct carotico-cavernous fistulas (CCFs). We prospectively collected clinical and radiological data of all patients who underwent embolization of direct CCFs at our institution over a period of 21 months. The clinical parameters, angioarchitecture, presence of cortical venous reflux, volume of Onyx used, number of coils used, extent of embolization and complications were recorded. A total of 21 consecutive patients (18 men and 3 women, 14 to 48 years) with direct CCF underwent embolization with a combination of coils and Onyx. Embolization was done through the arterial route in all cases. Complete obliteration of the fistula was achieved in 19 of 21 cases. Cast embolization in middle cerebral artery occurred in one patient; however, the cast was completely retrieved with Solitaire device, and the patient did not have any neurological deficit. All completely treated patients reported relief of symptoms at varying intervals. At 6-month follow-up, none of the patients with complete occlusion of the fistula showed any recurrence. The adjuvant use of Onyx with detachable coils in direct CCF through the arterial route is a safe and effective method for embolization with immediate and complete occlusion of the fistula. To the best of our knowledge, this is the first case series of demonstration of arterial use of Onyx with coils in the treatment of direct CCFs.

77 FR 40083 - Certain Personal Data and Mobile Communications Devices and Related Software; Institution of a...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-06

... Communications Devices and Related Software; Institution of a Formal Enforcement Proceeding; Denial of Request... subsidiary NeXT Software, Inc., both of Cupertino, California (collectively, ``Apple''), alleging a violation... importation of certain personal data and mobile communications devices and related software. 75 FR 17434 (Apr...

Clinical and Angiographic Outcomes with the Combined Local Aspiration and Retriever in the North American Solitaire Stent-Retriever Acute Stroke (NASA) Registry.

PubMed

Malisch, Tim W; Zaidat, Osama O; Castonguay, Alicia C; Marden, Franklin A; Gupta, Rishi; Sun, Chung-Huan J; Martin, Coleman O; Holloway, William E; Mueller-Kronast, Nils; English, Joey; Linfante, Italo; Dabus, Guilherme; Bozorgchami, Hormozd; Xavier, Andrew; Rai, Ansaar T; Froehler, Michael; Badruddin, Aamir; Nguyen, Thanh N; Taqi, M Asif; Abraham, Michael G; Janardhan, Vallabh; Shaltoni, Hashem; Novakovic, Robin; Yoo, Albert J; Abou-Chebl, Alex; Chen, Peng Roc; Britz, Gavin W; Kaushal, Ritesh; Nanda, Ashish; Nogueira, Raul G

2018-02-01

Various techniques are used to enhance the results of mechanical thrombectomy with stent-retrievers, including proximal arrest with balloon guide catheter (BGC), conventional large bore proximal catheter (CGC), or in combination with local aspiration through a large-bore catheter positioned at the clot interface (Aspiration-Retriever Technique for Stroke [ARTS]). We evaluated the impact of ARTS in the North American Solitaire Acute Stroke (NASA) registry. Data on the use of the aspiration technique were available for 285 anterior circulation patients, of which 29 underwent ARTS technique, 131 CGC, and 125 BGC. Baseline demographics were comparable, except that ARTS patients are less likely to have hypertension or atrial fibrillation. The ARTS group had more ICA occlusions (41.4 vs. 22% in the BGC, p = 0.04 and 26% in CGC, p = 0.1) and less MCA/M1 occlusions (44.8 vs. 68% in BGC and 62% in CGC). Time from arterial puncture to reperfusion or end of procedure with ARTS was shorter than with CGC (54 vs. 91 min, p = 0.001) and was comparable to the BGC time (54 vs. 67, p = 0.11). Final degree of reperfusion was comparable among the groups (TICI [modified Thrombolysis in Cerebral Infarction] score 2b or higher was 72 vs. 70% for CGC vs. 78% for BGC). Procedural complications, mortality, and good clinical outcome at 90 days were similar between the groups. The ARTS mechanical thrombectomy in acute ischemic stroke patients appears to yield better results as compared to the use of CGCs with no significant difference when compared to BGC. This early ARTS technique NASA registry data are limited by the earlier generation distal large bore catheters and small sample size. Future studies should focus on the comparison of ARTS and BGC techniques.

Cost-Effectiveness of Solitaire Stent Retriever Thrombectomy for Acute Ischemic Stroke

PubMed Central

Shireman, Theresa I.; Wang, Kaijun; Saver, Jeffrey L.; Goyal, Mayank; Bonafé, Alain; Diener, Hans-Christoph; Levy, Elad I.; Pereira, Vitor M.; Albers, Gregory W.; Cognard, Christophe; Hacke, Werner; Jansen, Olav; Jovin, Tudor G.; Mattle, Heinrich P.; Nogueira, Raul G.; Siddiqui, Adnan H.; Yavagal, Dileep R.; Devlin, Thomas G.; Lopes, Demetrius K.; Reddy, Vivek K.; de Rochemont, Richard du Mesnil; Jahan, Reza; Vilain, Katherine A.; House, John; Lee, Jin-Moo; Cohen, David J.

2017-01-01

Background and Purpose Clinical trials have demonstrated improved 90-day outcomes for patients with acute ischemic stroke treated with stent retriever thrombectomy plus tissue-type plasminogen activator (SST+tPA) compared with tPA. Previous studies suggested that this strategy may be cost-effective, but models were derived from pooled data and older assumptions. Methods In this prospective economic substudy conducted alongside the SWIFT-PRIME trial (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke), in-trial costs were measured for patients using detailed medical resource utilization and hospital billing data. Utility weights were assessed at 30 and 90 days using the EuroQol-5 dimension questionnaire. Post-trial costs and life-expectancy were estimated for each surviving patient using a model based on trial data and inputs derived from a contemporary cohort of ischemic stroke survivors. Results Index hospitalization costs were $17 183 per patient higher for SST+tPA than for tPA ($45 761 versus $28 578; P<0.001), driven by initial procedure costs. Between discharge and 90 days, costs were $4904 per patient lower for SST+tPA than for tPA ($11 270 versus $16 174; P=0.014); total 90-day costs remained higher with SST+tPA ($57 031 versus $44 752; P<0.001). Higher utility values for SST+tPA led to higher in-trial quality-adjusted life years (0.131 versus 0.105; P=0.005). In lifetime projections, SST+tPA was associated with substantial gains in quality-adjusted life years (6.79 versus 5.05), cost savings of $23 203 per patient and was economically dominant when compared with tPA in 90% of bootstrap replicates. Conclusions Among patients with acute ischemic stroke enrolled in the SWIFT-PRIME trial, SST increased initial treatment costs, but was projected to improve quality-adjusted life-expectancy and reduce healthcare costs over a lifetime horizon compared with tPA. PMID:28028150

21 CFR 872.2060 - Jaw tracking device.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) MEDICAL DEVICES DENTAL DEVICES Diagnostic Devices § 872.2060 Jaw tracking device. (a) Jaw tracking device... Controls Guidance Document: Dental Sonography and Jaw Tracking Devices.” [68 FR 67367, Dec. 2, 2003] ...

Spontaneous Solitaire™ AB Thrombectomy Stent Detachment During Stroke Treatment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Akpinar, Suha, E-mail: akpinarsuha@hotmail.com; Yilmaz, Guliz, E-mail: glz.yilmaz@hotmail.com

Spontaneous Solitaire™ stent retriever detachment is a rarely defined entity seen during stroke treatment, which can result in a disastrous clinical outcome if it cannot be solved within a critical stroke treatment time window. Two solutions to this problem are presented in the literature. The first is to leave the stent in place and apply angioplasty to the detached stent, while the second involves surgically removing the stent from the location at which it detached. Here, we present a case of inadvertent stent detachment during stroke treatment for a middle cerebral artery M1 occlusion resulting in progressive thrombosis. The detachedmore » stent was removed endovascularly by another Solitaire stent, resulting in the recanalization of the occluded middle cerebral artery.« less

76 FR 45860 - In the Matter of Certain Electronic Devices, Including Wireless Communication Devices, Portable...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-01

..., Including Wireless Communication Devices, Portable Music and Data Processing Devices, and Tablet Computers... electronic devices, including wireless communication devices, portable music and data processing devices, and... electronic devices, including wireless communication devices, portable music and data processing devices, and...

77 FR 58576 - Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-21

... Devices, Portable Music and Data Processing Devices, Computers, and Components Thereof; Institution of... communication devices, portable music and data processing devices, computers, and components thereof by reason... certain wireless communication devices, portable music and data processing devices, computers, and...

78 FR 34669 - Certain Electronic Devices, Including Wireless Communication Devices, Portable Music and Data...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-10

..., Including Wireless Communication Devices, Portable Music and Data Processing Devices, and Tablet Computers... importing wireless communication devices, portable music and data processing devices, and tablet computers... certain electronic devices, including wireless communication devices, portable music and data processing...

78 FR 16865 - Certain Electronic Devices, Including Wireless Communication Devices, Portable Music and Data...

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2013-03-19

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-794] Certain Electronic Devices, Including Wireless Communication Devices, Portable Music and Data Processing Devices, and Tablet Computers... certain electronic devices, including wireless communication devices, portable music and data processing...

78 FR 1247 - Certain Electronic Devices, Including Wireless Communication Devices, Tablet Computers, Media...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-08

... Wireless Communication Devices, Tablet Computers, Media Players, and Televisions, and Components Thereof... devices, including wireless communication devices, tablet computers, media players, and televisions, and... wireless communication devices, tablet computers, media players, and televisions, and components thereof...

77 FR 60720 - Certain Electronic Devices, Including Wireless Commmunication Devices, Portable Music and Data...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-04

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-794] Certain Electronic Devices, Including Wireless Commmunication Devices, Portable Music and Data Processing Devices, and Tablet Computers... communication devices, portable music and data processing devices, and tablet computers, imported by Apple Inc...

Suivi prospectif sur 5 ans des tentatives de suicide en population clinique dans la région de Fès, Maroc

PubMed Central

Aarab, Chadya; Elghazouani, Fatima; Aalouane, Rachid; Rammouz, Ismail

2014-01-01

Au Maroc, les tentatives de suicide (TS) demeurent un sujet mal évalué à cause de considérations socioculturelles et l'absence d'approche longitudinale. L'objectif principal était d’évaluer le devenir des suicidants après 5ans au centre universitaire psychiatrique de Fès, les objectifs secondaires étaient l'estimation de la prévalence des TS, préciser les étiologies les plus fréquentes, et établir une corrélation entre les paramètres sociodémographiques, cliniques et évolutifs. Etude prospective à visée transversale et longitudinale, incluant les suicidants vus à l'hôpital psychiatrique de Fès, avec un suivi longitudinal sur 5ans. L’évaluation a été faite par un hétéro-questionnaire et le Mini International Neuropsychiatric Interview (MINI) cherchant le trouble psychiatrique sous jacent. On a recruté 105 patients suicidants, 62% des femmes, l’âge moyen est de 29,23ans. La prévalence des tentatives de suicide est de 3% sur l'ensemble des consultants à l’établissement. Les troubles de l'humeur, psychotiques et de personnalité ont occupé respectivement 37,6%, 27,7%, et 25,7% des cas. La récidive suicidaire a été notée chez 54% des patients, était significativement corrélée à la vie solitaire (P: 0,039) et à la présence d'antécédents familiaux de TS (P: 0,046). L'utilisation de moyens violents était significativement fréquente chez les patients psychotiques. Après 5ans, 32 patients ont répondu à notre appel. Le taux de récidive était de 15%. On a noté trois cas de décès dont deux suicides confirmés. Les résultats confirment les données de la littérature scientifique avec certaines particularités cliniques et évolutives. PMID:25478042

48 CFR 252.225-7017 - Photovoltaic Devices.

Code of Federal Regulations, 2012 CFR

2012-10-01

... articles from which it was transformed. Designated country means— (i) A World Trade Organization Government..., Taiwan (known in the World Trade Organization as “the Separate Customs Territory of Taiwan, Penghu... country photovoltaic devices. (End of clause) [76 FR 78861, Dec. 20, 2011, as amended at 77 FR 13013, Mar...

76 FR 41522 - In the Matter of Certain Electronic Devices, Including Mobile Phones, Mobile Tablets, Portable...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-14

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-771] In the Matter of Certain Electronic Devices, Including Mobile Phones, Mobile Tablets, Portable Music Players, and Computers, and Components... certain mobile phones, mobile tablets, portable music players, and computers. 76 FR 24051 (Apr. 29, 2011...

78 FR 68714 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-15

... the device materials must be performed; (iv) Performance data must demonstrate acceptable mechanical properties under simulated clinical use conditions including insertion and removal of the device; (v...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-24

... methods for medical device comparative analyses, best practices and best design and analysis methods. II... the performance of medical devices (including comparative effectiveness studies). The centers...

78 FR 24775 - Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-26

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-745] Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and Components Thereof; Commission Decision... importation of certain wireless communication devices, portable music and data processing devices, computers...

78 FR 12785 - Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-25

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-745] Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and Components Thereof; Commission Decision... importation of certain wireless communication devices, portable music and data processing devices, computers...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-15

...] International Medical Device Regulators Forum; Medical Device Single Audit Program International Coalition Pilot... Drug Administration (FDA) is announcing participation in the Medical Device Single Audit Program International Coalition Pilot Program. The Medical Device Single Audit Program (MDSAP) was designed and...

77 FR 52759 - Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-30

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-745] Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and Components Thereof; Notice of... communication devices, portable music and data processing devices, computers and components thereof by reason of...

77 FR 51571 - Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-24

... Music and Data Processing Devices, Computers, and Components Thereof; Notice of Receipt of Complaint... complaint entitled Wireless Communication Devices, Portable Music and Data Processing Devices, Computers..., portable music and data processing devices, computers, and components thereof. The complaint names as...

75 FR 33169 - Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-11

.... FDA-2008-N-0163] (formerly Docket No. 2001N-0067) RIN 0910-AG21 Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam... the Federal Register of August 4, 2009 (74 FR 38686) which classified dental amalgam as a class II...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No... Serological Reagents; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correction. SUMMARY: In the Federal Register of March 9, 2012 (76 FR 14272), the Food and Drug Administration (FDA...

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fjetland, Lars, E-mail: lars.fjetland@lyse.net; Roy, Sumit; Kurz, Kathinka D.

Purpose: To evaluate the safety and efficacy of neurointerventional procedures in acute stroke patients performed by a team of vascular interventional radiologists in close cooperation with diagnostic neuroradiologists and stroke neurologists and to compare the results with those of previous reports from centres with specialised interventional neuroradiologists. Material and Methods: A total of 39 patients with acute ischemic stroke due to large-vessel occlusion not responding to or not eligible for intravenous thrombolysis were treated with either intra-arterial thrombolysis or mechanical thrombectomy (Penumbra System or solitaire FR thrombectomy system, respectively) and included in our prospective study. Outcomes were measured using themore » modified Rankin scale after 90 days, and recanalization was assessed by thrombolysis using the myocardial infarction score. Results: Mean patient age was 68.3 {+-} 14.2 years; the average National Institutes of Health Stroke Scale score at hospital admission was 17.2 (SD = 6.2 [n = 38]). Successful recanalization was achieved in 74.4 % of patients. Median time from clinical onset to recanalization was 5 h 11 min. Procedure-related complications occurred in 5 % of patients, and 7.5 % had a symptomatic intracerebral hemorrhage. Of the patients, 22.5 % died within the first 90 postprocedural days, 5 % of these from cerebral causes. Patients who were successfully recanalized had a clinical better outcome at follow-up than those in whom treatment failed. Of the patients, 35.9 % had an mRS score {<=}2 after 90 days. Conclusion: Our results are in line with those in the published literature and show that a treatment strategy with general interventional radiologists performing neurointerventional procedures in acute stroke patients with large vessel occlusions can be achieved to the benefit of patients.« less

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-09

...] Medical Device Innovation Initiative; Public Meeting; Request for Comments AGENCY: Food and Drug... Administration (FDA) is announcing a public meeting entitled ``CDRH's Medical Device Innovation Initiative Public... Center for Devices and Radiological Health's (CDRH) document, ``Medical Device Innovation Initiative...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-28

...] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory... and 11, 2012, the committee will discuss general issues related to medical devices intended for obese...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-24

...] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave...

76 FR 29006 - In the Matter of Certain Motion-Sensitive Sound Effects Devices and Image Display Devices and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-19

... Effects Devices and Image Display Devices and Components and Products Containing Same; Notice of... United States after importation of certain motion-sensitive sound effects devices and image display... devices and image display devices and components and products containing same that infringe one or more of...

76 FR 14028 - Center for Devices and Radiological Health 510(k) Implementation: Online Repository of Medical...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-15

...] Center for Devices and Radiological Health 510(k) Implementation: Online Repository of Medical Device... public meeting entitled ``510(k) Implementation: Discussion of an Online Repository of Medical Device... establish an online public repository of medical device labeling and strategies for displaying device...

76 FR 28689 - Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-18

.... FDA-2011-N-0103] Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus... of the Microbiology Devices Advisory Panel (the Panel). In addition, the proposed rule would... in the Federal Register. 1. Transcript of the FDA Microbiology Devices Panel meeting, March 7, 2002...

75 FR 30794 - Notice of Intent To Grant Exclusive Patent License; AmberWave Systems Corporation

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-02

..., power transistor devices, and power devices in the United States, the Government-owned inventions... amplifiers, radio frequency power transistor devices, and power devices and their use for the fabrication of...

Serious game design principles: The impact of game design on learning outcomes

NASA Astrophysics Data System (ADS)

Martin, Michael W.

This dissertation examines the research question "How do video game design principles affect learning outcomes in serious games?" This research first develops a theoretical foundation concerning the meaning of the terms "game" and "serious game". This conceptual clarification is broken down into analytic propositions, which state that games have participants, rules, goals and challenges, and synthetic propositions, which state that the games should be intrinsically compelling, provide meaningful choices, and be self encapsulated. Based on these synthetic propositions, three hypotheses were developed. The hypotheses are that games with an enhanced aesthetic presentation, more meaningful choices, or provide player competition will elicit higher learning outcomes than identical games without these factors. These hypotheses were tested via a quantitative experiment involving 172 undergraduate students in the Old Dominion University Chemistry Department. The students were asked to play a chemistry-oriented serious game entitled Element Solitaire©, which was created by the research author. The students were randomly given different treatments of the Element Solitaire© game to play, and the difference between their learning outcomes were compared. The experimental results demonstrated that the aesthetic presentation of a game can have a significant impact upon the learning outcome. The experiment was not able to discern significant effects from the choice or competition conditions, but further examination of the experimental data did reveal some insight into these aspects of serious game design. Choices need to provide the player with options that have a sufficient value that they will be considered and the application of competition within games needs to be judiciously implemented to promote a positive affect for all players. The results of the theoretical foundations and empirical evidence were then combined with additional theoretical research to develop a set of design principles and a proposed serious game development process. These guidelines were researched and examined via the design and development process of several serious game prototypes and the examination of a large body of existing serious games. The end result is a practical procedure that is rooted in theory and quantitative experimentation.

The mysterious Spotted Green Pigeon and its relation to the Dodo and its kindred.

PubMed

Heupink, Tim H; van Grouw, Hein; Lambert, David M

2014-07-16

The closely related and extinct Dodo (Raphus cucullatus) and Rodrigues Solitaire (Pezophaps solitaria), both in the subfamily Raphinae, are members of a clade of morphologically very diverse pigeons. Genetic analyses have revealed that the Nicobar Pigeon (Caloenas nicobarica) is the closest living relative of these birds, thereby highlighting their ancestors' remarkable migration and morphological evolution. The Spotted Green Pigeon (Caloenas maculata) was described in 1783 and showed some similarities to the Nicobar Pigeon. Soon however the taxon fell into obscurity, as it was regarded as simply an abnormal form of the Nicobar Pigeon. The relationship between both taxa has occasionally been questioned, leading some ornithologists to suggest that the two may in fact be different taxa. Today only one of the original two specimens survives and nothing is known about the origin of the taxon. Due to its potential close relationship, the Spotted Green Pigeon may hold clues to the historical migration, isolation and morphological evolution of the Dodo and its kindred. We use ancient DNA methodologies to investigate the phylogeny and authenticity of the Spotted Green Pigeon. A novel extraction method with the ability to retain and purify heavily fragmented DNA is used to investigate two feathers from the sole surviving specimen. Maximum Likelihood phylogenetic analyses reveal that the Spotted Green Pigeon is a unique lineage and together with the Nicobar Pigeon, is basal to the Dodo and Rodrigues Solitaire. The distance observed for the Spotted Green Pigeon and Nicobar Pigeon is larger than that observed within other Pigeon species, indicating that the Spotted Green pigeon is a unique taxon, thereby also indicating it is a genuine addition to the list of extinct species. The phylogenetic placement of the Spotted Green Pigeon indicates that the ancestors of both Caloenas and therefore Raphinae displayed and shared the following traits: ability of flight, semi-terrestrial habits and an affinity towards islands. This set of traits supports the stepping stone hypothesis, which states that the Raphinae got to their respective localities by island hopping from India or Southeast Asia.

The mysterious Spotted Green Pigeon and its relation to the Dodo and its kindred

PubMed Central

2014-01-01

Background The closely related and extinct Dodo (Raphus cucullatus) and Rodrigues Solitaire (Pezophaps solitaria), both in the subfamily Raphinae, are members of a clade of morphologically very diverse pigeons. Genetic analyses have revealed that the Nicobar Pigeon (Caloenas nicobarica) is the closest living relative of these birds, thereby highlighting their ancestors’ remarkable migration and morphological evolution. The Spotted Green Pigeon (Caloenas maculata) was described in 1783 and showed some similarities to the Nicobar Pigeon. Soon however the taxon fell into obscurity, as it was regarded as simply an abnormal form of the Nicobar Pigeon. The relationship between both taxa has occasionally been questioned, leading some ornithologists to suggest that the two may in fact be different taxa. Today only one of the original two specimens survives and nothing is known about the origin of the taxon. Due to its potential close relationship, the Spotted Green Pigeon may hold clues to the historical migration, isolation and morphological evolution of the Dodo and its kindred. Results We use ancient DNA methodologies to investigate the phylogeny and authenticity of the Spotted Green Pigeon. A novel extraction method with the ability to retain and purify heavily fragmented DNA is used to investigate two feathers from the sole surviving specimen. Maximum Likelihood phylogenetic analyses reveal that the Spotted Green Pigeon is a unique lineage and together with the Nicobar Pigeon, is basal to the Dodo and Rodrigues Solitaire. Conclusions The distance observed for the Spotted Green Pigeon and Nicobar Pigeon is larger than that observed within other Pigeon species, indicating that the Spotted Green pigeon is a unique taxon, thereby also indicating it is a genuine addition to the list of extinct species. The phylogenetic placement of the Spotted Green Pigeon indicates that the ancestors of both Caloenas and therefore Raphinae displayed and shared the following traits: ability of flight, semi-terrestrial habits and an affinity towards islands. This set of traits supports the stepping stone hypothesis, which states that the Raphinae got to their respective localities by island hopping from India or Southeast Asia. PMID:25027719

75 FR 64742 - In the Matter of Certain Devices Having Elastomeric Gel and Components Thereof; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-20

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-732] In the Matter of Certain Devices... (EDIS) at http://edis.usitc.gov . Hearing-impaired persons are advised that information on this matter... supplemented, of Interactive Life Forms, LLC of Austin, Texas (``ILF''). 75 FR 47027 (Aug. 4, 2010). The...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-01

...] Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting... comment period for the notice announcing a meeting of the Molecular and Clinical Genetics Panel (the panel... Register of February 7, 2011 (76 FR 6623), FDA published a notice announcing a meeting of the Molecular and...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-22

...] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Ophthalmic Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... Glaukos iStent Trabecular Micro-Bypass Stent, Model GTS-100 L/R, sponsored by Glaukos Corp. The device is...

76 FR 50485 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-15

...] Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY... an amendment to the notice of meeting of the Obstetrics and Gynecology Devices Panel of the Medical... Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee would be held on September...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-05

...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the..., FDA announced that a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-01

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Immunology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY... postponing the meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee scheduled...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Neurological Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

76 FR 12973 - Neurological Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-09

...] Neurological Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY: Food and Drug... notice of meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee. This... INFORMATION: In the Federal Register of February 7, 2011, FDA announced that a meeting of the Neurological...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-22

...] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and... of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee. General... also comes with a sheath, introducer, loader, dilator, balloon (used to pre-dilate the native annulus...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-27

...] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and... of Committee: Circulatory System Devices Panel of the Medical Devices Advisory Committee. General..., introducer, loader, dilator, balloon (used to pre-dilate the native annulus) and a crimper. FDA intends to...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Microbiology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

76 FR 69034 - Microbiology Devices; Classification of In Vitro Diagnostic Device for Yersinia Species Detection

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-07

... Drug Administration 21 CFR Part 866 Microbiology Devices; Classification of In Vitro Diagnostic Device... CFR Part 866 [Docket No. FDA-2011-N-0729] Microbiology Devices; Classification of In Vitro Diagnostic... of the Microbiology Devices Advisory Panel (the panel). FDA is publishing in this document the...

75 FR 57968 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-23

...] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory... committee will discuss, make recommendations, and vote on information related to the PMA for the LAP-BAND...

76 FR 54156 - National Standards for Traffic Control Devices; the Manual on Uniform Traffic Control Devices for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-31

... traffic control device design, location, or operation that have made some existing devices in the field...-2010-0159] RIN 2125-AF43 National Standards for Traffic Control Devices; the Manual on Uniform Traffic Control Devices for Streets and Highways; Revision AGENCY: Federal Highway Administration (FHWA...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-06

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

75 FR 19340 - Wireless Technologies, Devices, and Services

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-14

... Technologies, Devices, and Services AGENCY: Federal Communications Commission. ACTION: Proposed rule. SUMMARY... technologies, devices, and services. Specifically, the Commission seeks comment regarding particular changes to... concise rules that facilitate new wireless technologies, devices and services, and are easy for the public...

77 FR 16126 - Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-19

.... FDA-2012-N-0159] Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for... convened a meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee (Microbiology Devices Panel) on June 29, 2011 (Ref. 2). Although not a formal reclassification meeting, panel...

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...

75 FR 44172 - Neurological and Physical Medicine Devices; Designation of Special Controls for Certain Class II...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-28

... [Docket No. FDA-2009-N-0493] RIN 0910-ZA37 Neurological and Physical Medicine Devices; Designation of... document proposed to amend certain neurological and physical medicine device regulations to establish... to amend certain neurological device and physical medicine device regulations to establish special...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-17

... Suction Apparatus Device Intended for Negative Pressure Wound Therapy AGENCY: Food and Drug Administration...- powered suction apparatus device intended for negative pressure wound therapy (NPWT) into class II... ``Class II Special Controls Guidance Document: Non-Powered Suction Apparatus Device Intended for Negative...

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...

78 FR 35173 - Physical Medicine Devices; Reclassification of Stair-Climbing Wheelchairs

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-12

.... Electromagnetic interference: The device may interfere with the operation of other electrical devices or be... electromagnetic compatibility testing as well as characterization of speed/acceleration, battery longevity, and... electrical safety and electromagnetic compatibility of the device. Performance testing must demonstrate...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-19

... information that will have been reviewed by the applicant during the course of its development of the device..., infants, children, adolescents) that suffer from the disease or condition that the device is intended to.... FDA-2009-N-0458] RIN 0910-AG29 Medical Devices; Pediatric Uses of Devices; Requirement for Submission...

77 FR 39498 - Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-03

...] Guidances for Industry and Food and Drug Administration Staff: Computer-Assisted Detection Devices Applied... Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to... guidance, entitled ``Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-30

...] Public Meeting--Strengthening the National Medical Device Postmarket Surveillance System; Request for... ``Public Meeting--Strengthening the National Medical Device Postmarket Surveillance System.'' The purpose of the meeting is to solicit public feedback regarding the medical device postmarket surveillance...

78 FR 1162 - Cardiovascular Devices; Reclassification of External Cardiac Compressor

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-08

... safety and electromagnetic compatibility; For devices containing software, software verification... electromagnetic compatibility; For devices containing software, software verification, validation, and hazard... electrical components, appropriate analysis and testing must validate electrical safety and electromagnetic...

75 FR 62565 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-12

... Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and..., portable music and data processing devices, computers and components thereof. The complaint names as...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-18

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus... AND MICROBIOLOGY DEVICES 0 1. The authority citation for 21 CFR part 866 continues to read as follows...

75 FR 68619 - In the Matter of Certain Wireless Communication Devices, Portable Music and Data Processing...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-08

... Communication Devices, Portable Music and Data Processing Devices, Computers and Components Thereof; Notice of... within the United States after importation of certain wireless communication devices, portable music and... music and data processing devices, computers and components thereof that infringe one or more of claim...

77 FR 28460 - National Standards for Traffic Control Devices; the Manual on Uniform Traffic Control Devices for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-14

...-2010-0159] RIN 2125-AF43 National Standards for Traffic Control Devices; the Manual on Uniform Traffic Control Devices for Streets and Highways; Revision AGENCY: Federal Highway Administration (FHWA..., approved by the FHWA, and recognized as the national standard for traffic control devices used on all...

78 FR 21129 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-09

... always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down... conditions by means other than the generation of deep heat within body tissues. On July 6, 2012 (77 FR 39953... than 2 business days before the meeting. If FDA is unable to post the background material on its Web...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-10

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-07

...] Educational Forum on Medical Device Reporting, Complaint Files, and Recalls, Corrections, and Removals; Public...), in collaboration with the FDA Medical Device Industry Coalition (FMDIC), is announcing a public workshop entitled ``Educational Forum on Medical Device Reporting, Complaint Files, and Recalls...

77 FR 28621 - Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-15

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-745] Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers and Components Thereof; Notice of Request for Statements on the Public Interest AGENCY: U.S. International Trade Commission. ACTION: Notice...

77 FR 65580 - Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-29

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-856] Certain Wireless Communication Devices, Portable Music and Data Processing Devices, Computers, and Components Thereof AGENCY: U.S. International Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given that the U.S. International...

75 FR 29560 - Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-26

...] Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development; Notice of... entitled ``Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development... an initiative to proactively facilitate medical device innovation to address unmet public health...

47 CFR 80.271 - Technical requirements for portable survival craft radiotelephone transceivers.

Code of Federal Regulations, 2011 CFR

2011-10-01

...:9 with no significant adverse effect upon the performance of the device; (5) The transceivers must... Commission's database. [51 FR 31213, Sept. 2, 1986, as amended at 63 FR 36607, July 7, 1998; 73 FR 4483, Jan...

75 FR 30300 - Restricting the Mailing of Replica or Inert Explosive Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-01

... not dangerous but bear a realistic appearance to explosive devices, to Registered Mail\\TM\\ service... explosive devices such as simulated grenades, but that are not dangerous, are permitted in the mail when all...

75 FR 76020 - Prospective Grant of Exclusive License: Devices for Treating Dysphagia and Dysphonia

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-07

... patents and patent applications intended for licensure disclose or cover a system, device and method for... device allows the patient coordinate muscular movement with a button press to permit volitional...

76 FR 39121 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-05

... Certain Electronic Devices, Including Wireless Communication Devices, Portable Music and Data, and Tablet..., portable music and data processing devices, and tablet computers. The complaint names as respondent Apple...

76 FR 35910 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-20

... Motion-Sensitive Sound Effects Devices and Image Display Devices and Components and Products Containing... sale within the United States after importation of certain motion- sensitive sound devices and image...

76 FR 66283 - Notice of Intent To Grant Partially Exclusive Patent License; BOLD Industries, Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-26

... Method for a Mobile Tracking Device.//U.S. Patent Application No. 20110036998 filed on August 14, 2009: Countermeasure Device for a Mobile Tracking Device.//U.S. Patent Application No. 20110113949 filed on May 12, 2010: Modulation Device for a Mobile Tracking Device.//U.S. Patent Application Serial No. 12/778,643...

75 FR 17093 - Neurological and Physical Medicine Devices; Designation of Special Controls for Certain Class II...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-05

... [Docket No. FDA-2009-N-0493] RIN 0910-ZA37 Neurological and Physical Medicine Devices; Designation of... proposing to amend certain neurological device and physical medicine device regulations to establish special..., FDA is proposing to amend the physical medicine devices regulation at Sec. 890.5850 (21 CFR 890.5850...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0606] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice...) is announcing an amendment to the notice of a meeting of the General and Plastic Surgery Devices...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of... Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-20

...] Medical Device User Fee Act; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of... public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee... use them for the process for the review of medical device applications. The current legislative...

75 FR 8399 - In the Matter of Certain Mobile Communications and Computer Devices and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-24

... Communications and Computer Devices and Components Thereof; Notice of Investigation AGENCY: U.S. International... States after importation of certain mobile communications and computer devices and components thereof by... importation of certain mobile communications or computer devices or components thereof that infringe one or...

76 FR 21237 - Medical Devices; Obstetrical and Gynecological Devices; Classification of the Hemorrhoid...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-15

... reasonable assurance of safety and effectiveness of the device. A hemorrhoid prevention pressure wedge... provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device for its...

78 FR 68091 - Certain Marine Sonar Imaging Devices, Products Containing the Same, and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-13

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-898] Certain Marine Sonar Imaging Devices... importation of certain marine sonar imaging devices, products containing the same, and components thereof by... marine sonar imaging devices, products containing the same, and components thereof by reason of...

75 FR 10502 - In the Matter of Certain Electronic Devices, Including Handheld Wireless Communications Devices...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-08

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-667; Investigation No. 337-TA-673] In the Matter of Certain Electronic Devices, Including Handheld Wireless Communications Devices; Notice of... Entirety AGENCY: U.S. International Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given that...

78 FR 33447 - Draft Applications for Sealed Source and Device Evaluation and Registration

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-04

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0104] Draft Applications for Sealed Source and Device... for sealed source and device evaluation and registration. The NRC is requesting public comment on... for Sealed Source and Device Evaluation and Registration.'' The document has been updated from the...

78 FR 19717 - Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction...

77 FR 20417 - Certain Cameras and Mobile Devices, Related Software and Firmware, and Components Thereof and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-04

... INTERNATIONAL TRADE COMMISSION [DN 2891] Certain Cameras and Mobile Devices, Related Software and... complaint entitled Certain Cameras and Mobile Devices, Related Software and Firmware, and Components Thereof... cameras and mobile devices, related software and firmware, and components thereof and products containing...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-21

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-12

... serious adverse health consequences, (2) the device is intended to be implanted in the human body for more... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0555] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Device...

77 FR 14989 - Medicare Program; Revisions to the Durable Medical Equipment, Prosthetics, Orthotics, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-14

... wheelchairs. Prosthetic devices are included in the definition of ``medical and other health services'' in section 1861(s)(8) of the Act. Prosthetic devices are defined as devices (other than dental) which replace... examples of prosthetic devices include cardiac pacemakers, cochlear implants, electrical continence aids...

75 FR 52629 - Medicare Program; Establishing Additional Medicare Durable Medical Equipment, Prosthetics...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-27

... wheelchairs. Prosthetic devices are included in the definition of ``medical and other health services'' under section 1861(s)(8) of the Act. Prosthetic devices are defined in this section of the Act as ``devices... insertion of an intraocular lens.'' Other examples of prosthetic devices include cardiac pacemakers...

78 FR 11207 - Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-15

...] Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation; Guidance for... devices intended for the treatment of atrial fibrillation. DATES: Submit either electronic or written... Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation'' to the Division of...

78 FR 27441 - NIJ Evaluation of Hand-Held Cell Phone Detector Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-10

... Hand-Held Cell Phone Detector Devices AGENCY: National Institute of Justice, Department of Justice...-held cell phone detector devices for participation in an evaluation by the NIJ Corrections Technology...-held cell phone detector devices for participation in an evaluation by the NIJ Corrections Technology...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-02

...] Draft Guidance for Industry and FDA Staff: Processing/ Reprocessing Medical Devices in Health Care... Devices in Health Care Settings: Validation Methods and Labeling.'' The recommendations in this guidance... Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling...

77 FR 36951 - Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-20

... into class II (special controls). FDA is proposing this reclassification on its own initiative based on... categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II...

77 FR 48160 - Division of Cardiovascular Devices 30-Day Notices and Annual Reports; Public Workshop; Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-13

...] Division of Cardiovascular Devices 30-Day Notices and Annual Reports; Public Workshop; Request for Comments... Cardiovascular Devices 30-Day Notices and Annual Reports.'' This public workshop will be cosponsored with... approval applications (PMAs), 30-day notices and annual reports, specifically for cardiovascular devices...

78 FR 25273 - Determination and Declaration Regarding Emergency Use of in Vitro Diagnostics for Detection of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-30

... Respiratory Protection Devices, and Respiratory Support Devices signed by then Secretary Michael Leavitt on... Act Declaration for Pandemic Influenza Diagnostics, Personal Respiratory Protection Devices, and Respiratory Support Devices signed by then Secretary Michael Leavitt on December 17, 2008. Notice of the EUAs...

75 FR 51829 - Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-23

...] Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and... entitled ``Medical Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility... experience or expertise with nanotechnology. There will be a limited number of round-table participants. FDA...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0427] Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and... Devices & Nanotechnology: Manufacturing, Characterization, and Biocompatibility Considerations.'' The...

Effect of Dielectric and Liquid on Plasma Sterilization Using Dielectric Barrier Discharge Plasma

PubMed Central

Mastanaiah, Navya; Johnson, Judith A.; Roy, Subrata

2013-01-01

Plasma sterilization offers a faster, less toxic and versatile alternative to conventional sterilization methods. Using a relatively small, low temperature, atmospheric, dielectric barrier discharge surface plasma generator, we achieved ≥6 log reduction in concentration of vegetative bacterial and yeast cells within 4 minutes and ≥6 log reduction of Geobacillus stearothermophilus spores within 20 minutes. Plasma sterilization is influenced by a wide variety of factors. Two factors studied in this particular paper are the effect of using different dielectric substrates and the significance of the amount of liquid on the dielectric surface. Of the two dielectric substrates tested (FR4 and semi-ceramic (SC)), it is noted that the FR4 is more efficient in terms of time taken for complete inactivation. FR4 is more efficient at generating plasma as shown by the intensity of spectral peaks, amount of ozone generated, the power used and the speed of killing vegetative cells. The surface temperature during plasma generation is also higher in the case of FR4. An inoculated FR4 or SC device produces less ozone than the respective clean devices. Temperature studies show that the surface temperatures reached during plasma generation are in the range of 30°C–66°C (for FR4) and 20°C–49°C (for SC). Surface temperatures during plasma generation of inoculated devices are lower than the corresponding temperatures of clean devices. pH studies indicate a slight reduction in pH value due to plasma generation, which implies that while temperature and acidification may play a minor role in DBD plasma sterilization, the presence of the liquid on the dielectric surface hampers sterilization and as the liquid evaporates, sterilization improves. PMID:23951023

Effect of dielectric and liquid on plasma sterilization using dielectric barrier discharge plasma.

PubMed

Mastanaiah, Navya; Johnson, Judith A; Roy, Subrata

2013-01-01

Plasma sterilization offers a faster, less toxic and versatile alternative to conventional sterilization methods. Using a relatively small, low temperature, atmospheric, dielectric barrier discharge surface plasma generator, we achieved ≥ 6 log reduction in concentration of vegetative bacterial and yeast cells within 4 minutes and ≥ 6 log reduction of Geobacillus stearothermophilus spores within 20 minutes. Plasma sterilization is influenced by a wide variety of factors. Two factors studied in this particular paper are the effect of using different dielectric substrates and the significance of the amount of liquid on the dielectric surface. Of the two dielectric substrates tested (FR4 and semi-ceramic (SC)), it is noted that the FR4 is more efficient in terms of time taken for complete inactivation. FR4 is more efficient at generating plasma as shown by the intensity of spectral peaks, amount of ozone generated, the power used and the speed of killing vegetative cells. The surface temperature during plasma generation is also higher in the case of FR4. An inoculated FR4 or SC device produces less ozone than the respective clean devices. Temperature studies show that the surface temperatures reached during plasma generation are in the range of 30°C-66 °C (for FR4) and 20 °C-49 °C (for SC). Surface temperatures during plasma generation of inoculated devices are lower than the corresponding temperatures of clean devices. pH studies indicate a slight reduction in pH value due to plasma generation, which implies that while temperature and acidification may play a minor role in DBD plasma sterilization, the presence of the liquid on the dielectric surface hampers sterilization and as the liquid evaporates, sterilization improves.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-08

...] Advancing Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices; Public... Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices.'' The purpose of the public meeting is to discuss performance evaluation of highly multiplexed microbiology/medical...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-19

... Ablation System to be used for the treatment of atrial fibrillation in patients who are undergoing open... catheter-based device developed for the treatment of atrial fibrillation. The system consists of the...

75 FR 5335 - Workshop on Pediatric Neurological and Neurocognitive Assessments for Cardiovascular Devices...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-02

...] Workshop on Pediatric Neurological and Neurocognitive Assessments for Cardiovascular Devices; Public... Neurocognitive Assessments for Cardiovascular Devices.'' The purpose of the public workshop is to solicit... various neurological and neurocognitive assessments for pediatric patients implanted with cardiovascular...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-19

...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the... INFORMATION: In the Federal Register of July 7, 2011, FDA announced that a meeting of the General and Plastic...

77 FR 51572 - Certain Wireless Consumer Electronics Devices and Components Thereof; Institution of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-24

... Electronics Devices and Components Thereof; Institution of Investigation Pursuant to 19 U.S.C. 1337 AGENCY: U... importation of certain wireless consumer electronics devices and components thereof by reason of infringement... wireless consumer electronics devices and components thereof that infringe one or more of claims 1, 6, 7, 9...

76 FR 41523 - In the Matter of Certain Mobile Communications and Computer Devices and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-14

... Communications and Computer Devices and Components Thereof; Notice of Commission Determination Not To Review an... in its entirety Inv. No. 337-TA-704, Certain Mobile Communications and Computer Devices and... importation of certain mobile communications and computer devices and components thereof by reason of...

76 FR 5206 - In the Matter of Certain Game Devices, Components Thereof, and Products Containing the Same...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-28

... INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-757] In the Matter of Certain Game Devices... importation of certain game devices, components thereof, and products containing the same by reason of... certain game devices, components thereof, and products containing the same that infringe one or more of...

78 FR 41937 - Joint Meeting of the Gastroenterology-Urology Panel and the Radiological Devices Panel of the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-12

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0816] Joint Meeting of the Gastroenterology-Urology Panel and the Radiological Devices Panel of the Medical...: Gastroenterology-Urology Panel and Radiological Devices Panel of the Medical Devices Advisory Committee. General...

21 CFR 870.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... devices intended for human use that are in commercial distribution. (b) The identification of a device in... device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic... referenced in this part are available on the Internet at http://www.fda.gov/cdrh/guidance.html. [52 FR 17735...

21 CFR 882.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... devices intended for human use that are in commercial distribution. (b) The identification of a device in... device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic... referenced in this part are available on the Internet at http://www.fda.gov/cdrh/guidance.html. [52 FR 17739...

21 CFR 886.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... devices intended for human use that are in commercial distribution. (b) The identification of a device in... that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device... in this part are available on the Internet at http://www.fda.gov/cdrh/guidance.html. [52 FR 33355...

21 CFR 868.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... devices intended for human use that are in commercial distribution. (b) The identification of a device in... device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic... referenced in this part are available on the Internet at http://www.fda.gov/cdrh/guidance.html. [52 FR 17734...

21 CFR 888.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... devices intended for human use that are in commercial distribution. (b) The identification of a device in... that has two or more types of uses (e.g., used both as a diagnostic device and as a surgical device) is... part are available on the Internet at http://www.fda.gov/cdrh/guidance.html. [52 FR 33702, Sept. 4...

78 FR 27971 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-13

...] Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Dental Products Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-11

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

75 FR 34484 - In the Matter of: Certain Portable Electronic Devices and Related Software; Notice of Investigation

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-17

... Devices and Related Software; Notice of Investigation AGENCY: U.S. International Trade Commission. ACTION... of certain portable electronic devices and related software by reason of infringement of certain... after importation of certain portable electronic devices or related software that infringe one or more...

76 FR 14414 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA-2011-N-0002] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Microbiology...

78 FR 69694 - Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-20

...] Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and... for Medical Devices in the Treatment of Obesity and Metabolic Diseases: How to Estimate and Reward... other interested parties of the development of medical devices for the treatment of morbid obesity and...

77 FR 2758 - Certain Portable Communication Devices; Institution of Investigation

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-19

... INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-827] Certain Portable Communication Devices... communication devices by reason of infringement of certain claims of U.S. Patent No. 5,926,636 (``the '636... certain portable communication devices that infringe one or more of claims 7-13 and 15 of the '636 patent...

76 FR 18472 - Medicare Program; Revisions to the Durable Medical Equipment, Prosthetics, Orthotics, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-04

....Prosthetic devices are included in the definition of ``medical and other health services'' under section 1861(s)(8) of the Act. Prosthetic devices are defined in this section of the Act as ``devices (other than... intraocular lens.'' Other examples of prosthetic devices include cardiac pacemakers, cochlear implants...

75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-05

... Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION... controls guidance documents for 11 neurological and physical medicine devices. FDA has developed a draft... stimulator device achieves ``aesthetic effects through physical change to the structure of the body'' as well...

75 FR 875 - Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-06

... imaging devices for use with imaging contrast agents or radiopharmaceuticals. FDA intends this guidance to..., for medical imaging devices for use with imaging contrast agents or radiopharmaceuticals. Further, the...] Guidance for Industry on New Contrast Imaging Indication Considerations for Devices and Approved Drug and...

77 FR 18828 - Guidance for Industry and Food and Drug Administration Staff; Factors To Consider When Making...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-28

... Assistance, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New... CONTACT: For devices regulated by CDRH: Ruth Fischer, Center for Devices and Radiological Health, Food and... search capability is available for all CDRH guidance documents at http://www.fda.gov/MedicalDevices...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-23

... test system into class II (special controls). The special control that will apply to these devices is the guidance document entitled ``Guidance for Industry and FDA Staff; Class II Special Controls... devices into class II (special controls) because special controls, in addition to general controls, will...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-15

... control by other users with a similar medical device. Exposure to non-ionizing radiation Wireless... Administration (FDA) is classifying the wireless air-conduction hearing aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable...

78 FR 79300 - Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems for Acute...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-30

... balloon and control system (IABP) devices when indicated for acute coronary syndrome, cardiac and non... and non-cardiac surgery, or complications of heart failure. The special controls for this device are.... FDA-2013-N-0581] Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems...

77 FR 8117 - Medical Devices; Cardiovascular Devices; Classification of the Endovascular Suturing System

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-14

... Administration (FDA) is classifying the endovascular suturing system into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance..., or FDA issues an order finding the device to be substantially equivalent, in accordance with section...

75 FR 27791 - Agency Information Collection Activities; Proposed Collection; Comment Request; Invitation to...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-18

... use device to be a medical device intended for users in a non-clinical environment that is managed... promoting the safe use of medical devices presented a significant health challenge for which the HHCC could... pilot program, we are requesting manufacturers and distributors of medical devices cleared for home use...

76 FR 59737 - In the Matter of Certain Digital Photo Frames and Image Display Devices and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-27

... Frames and Image Display Devices and Components Thereof; Notice of Institution of Investigation... United States after importation of certain digital photo frames and image display devices and components... certain digital photo frames and image display devices and components thereof that infringe one or more of...

78 FR 34132 - Certain Portable Electronic Communications Devices, Including Mobile Phones and Components...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-06

... INTERNATIONAL TRADE COMMISSION [Docket No 2958] Certain Portable Electronic Communications Devices, Including Mobile Phones and Components Thereof; Correction to Notice of Receipt of Complaint; Solicitation... of complaint entitled Certain Portable Electronic Communications Devices, Including Mobile Phones and...

77 FR 15390 - Certain Mobile Electronic Devices Incorporating Haptics; Receipt of Amended Complaint...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-15

... INTERNATIONAL TRADE COMMISSION [DN 2875] Certain Mobile Electronic Devices Incorporating Haptics.... International Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given that the U.S. International Trade Commission has received an amended complaint entitled Certain Mobile Electronic Devices...

76 FR 45268 - Reprocessing of Reusable Medical Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-28

... personal information provided. For additional information on submitting comments, see the ``Comments... problems in all steps of medical device reprocessing,\\1\\ including cleaning, disinfecting, and sterilizing... following issues: 1. What are the nature, scope, and impact of reusable medical device reprocessing problems...

78 FR 17940 - Certain Computerized Orthopedic Surgical Devices, Software, Implants, and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-25

..., Software, Implants, and Components Thereof; Notice of Receipt of Complaint; Solicitation of Comments... Certain Computerized Orthopedic Surgical Devices, Software, Implants, and Components Thereof, DN 2945; the... importation of certain computerized orthopedic surgical devices, software, implants, and components thereof...

77 FR 32996 - Certain Handheld Electronic Computing Devices, Related Software, and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-04

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-769] Certain Handheld Electronic Computing Devices, Related Software, and Components Thereof; Termination of the Investigation Based on... electronic computing devices, related software, and components thereof by reason of infringement of certain...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-21

...] Advancing Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices; Public... Multiplexed Microbiology/ Medical Countermeasure Devices'' that published in the Federal Register of August 8... the October 13, 2011, meeting, including the performance evaluation of highly multiplexed microbiology...

76 FR 30243 - Minimum Security Devices and Procedures

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-24

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision Minimum Security Devices and Procedures.... Title of Proposal: Minimum Security Devices and Procedures. OMB Number: 1550-0062. Form Number: N/A. Description: The requirement that savings associations establish a written security program is necessitated by...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-26

...; Hazards caused by electromagnetic interference and electrostatic discharge hazards; and Hearing loss. FDA... electromagnetic Electromagnetic compatibility. interference and electrostatic discharge hazards. Labeling. Hearing...

78 FR 34922 - Definition of Auditory Assistance Device

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-11

... Report and Order will apply to small businesses that choose to use, manufacture, design, import, or sell... production and marketing, and introduce more competition for such devices. The Commission decided that this... assistance devices using industry standard components employing relatively straight-forward designs at a...

78 FR 19711 - Center for Devices and Radiological Health: Experiential Learning Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-02

... Program (ELP). The ELP provides a formal training mechanism for regulatory review staff to visit research... medical device establishments, including, research, manufacturing, academia, and health care facilities.... Clinical use of orthopedic bone void Observation of surgical filler devices. procedures (posterolateral...

78 FR 52211 - Certain Electronic Devices Having Placeshifting or Display Replication and Products Containing...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-22

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-878] Certain Electronic Devices Having Placeshifting or Display Replication and Products Containing Same; Commission Determination Not To Review an... States after importation of certain electronic devices having placeshifting or display replication...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-09

...] Medical Device Innovation Initiative; Request for Comments AGENCY: Food and Drug Administration, HHS... availability of a document for public comment entitled ``Medical Device Innovation Initiative'' (the report... Innovation Initiative would consider the creation of a special Innovation Pathway intended to provide earlier...

75 FR 34482 - Certain Biometric Scanning Devices, Components Thereof, Associated Software, and Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-17

..., Components Thereof, Associated Software, and Products Containing the Same; Notice of Investigation AGENCY: U... scanning devices, components thereof, associated software, and products containing the same by reason of... after importation of certain biometric scanning devices, components thereof, associated software, or...

76 FR 48563 - Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2011...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-08

...-7205 Ventricular Assist Device (Destination Therapy) Facilities. XIII Medicare-Approved Lung JoAnna...-Approved Ventricular Assist Device (Destination Therapy) Facilities, Addendum XIII: Lung Volume Reduction...-Approved Ventricular Assist Device (Destination Therapy) Facilities (January Through March 2011) Addendum...

76 FR 15368 - Minimum Security Devices and Procedures

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-21

... DEPARTMENT OF THE TREASURY Office of Thrift Supervision Minimum Security Devices and Procedures... concerning the following information collection. Title of Proposal: Minimum Security Devices and Procedures... establish a written security program is necessitated by the Bank Protection Act (12 U.S.C. 1881-1884), which...

78 FR 15877 - Taxable Medical Devices; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-13

... Medical Devices; Correction AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Correction to final... on the excise tax imposed on the sale of certain medical devices, enacted by the Health Care and Education Reconciliation Act of 2010 in conjunction with the Patient Protection and Affordable Care Act...

76 FR 12743 - Medical Device Reporting; Malfunction Reporting Frequency

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0097] Medical Device Reporting; Malfunction Reporting Frequency AGENCY: Food and Drug Administration, HHS... compliance with FDA's Medical Device Reporting regulation, pending future FDA notice under the Federal Food...

77 FR 38829 - Certain Electronic Imaging Devices; Institution of Investigation

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-29

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-850] Certain Electronic Imaging Devices... States after importation of certain electronic imaging devices by reason of infringement of certain....usitc.gov . The public record for this investigation may be viewed on the Commission's electronic docket...

77 FR 64077 - National Highway-Rail Crossing Inventory Reporting Requirements

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-18

... about warning devices and signage, for each previously unreported and new public and private highway..., including current information about warning devices and signage, related to new and previously unreported... devices and signage * * * concerning each previously unreported crossing through which it operates or with...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-27

... as isoniazid test strips. Isoniazid test strips are considered pre-Amendment devices since they were... as methotrexate enzyme immunoassays. Methotrexate enzyme immunoassays are considered pre- Amendment... and PCP radioimmunoassays. PCP enzyme immunoassays and PCP radioimmunoassays are considered pre...

78 FR 16531 - Certain Electronic Devices for Capturing and Transmitting Images, and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-15

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-831] Certain Electronic Devices for Capturing and Transmitting Images, and Components Thereof; Commission Determination Not To Review an Initial... certain electronic devices for capturing and transmitting images, and components thereof. The complaint...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-27

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug... of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-03

...] Medical Device User Fee Rates for Fiscal Year 2011 AGENCY: Food and Drug Administration, HHS. ACTION... payment procedures for medical device user fees for fiscal year (FY) 2011. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee Amendments of 2007 (title II of the Food...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0142] Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public...

76 FR 22918 - In the Matter of Certain Handheld Electronic Computing Devices, Related Software, and Components...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-25

... Computing Devices, Related Software, and Components Thereof; Notice of Investigation AGENCY: U.S... devices, related software, and components thereof by reason of infringement of certain claims of U.S... devices, related software, and components thereof that infringe one or more of claims 1 and 5 of the '372...

77 FR 28455 - National Standards for Traffic Control Devices; the Manual on Uniform Traffic Control Devices for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-14

... Options for design and applications of traffic control devices, this Manual should not be considered a... application of traffic control devices, as well as in the location and design of roads and streets that the..., while this Manual provides Standards, Guidance, and Options for design and applications of traffic...

76 FR 36993 - Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-24

...; Clarification of Classification for Human Dura Mater; Technical Amendment AGENCY: Food and Drug Administration... amending the device regulations to clarify the applicability of the device classification for human dura..., human dura mater is now defined under 21 CFR 1271.3(d) as a HCT/P. As such, it is regulated under...

75 FR 20854 - Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-21

...] Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of Medical Device... related to the safe and effective use of medical device technology in the home environment. The workshop... the home environment. FDA will solicit feedback on: 1. The agency's current working definition of...

78 FR 9349 - Medical Devices; Ophthalmic Devices; Classification of the Eyelid Weight

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-08

... MR incompatibility or the conditions for safe use in an MR environment. Labeling will mitigate the... Amendments of 1976 (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), and the Food and...) and nonclinical testing evaluating the compatibility of the device in a MR environment. In addition...

78 FR 16707 - Certain Digital Photo Frames and Image Display Devices and Components Thereof; Issuance of a...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-18

... Image Display Devices and Components Thereof; Issuance of a Limited Exclusion Order and Cease and Desist... within the United States after importation of certain digital photo frames and image display devices and...: (1) The unlicensed entry of digital photo frames and image display devices and components thereof...

76 FR 20840 - Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-14

... into class II (special controls). The special control(s) that will apply to the device is entitled ``Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.'' The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety...

77 FR 31274 - Hazardous Materials: Harmonization With the United Nations Recommendations on the Transport of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-25

... (ICAO) Dangerous Goods Panel (DGP) regarding certain lithium ion battery-powered mobility aids (e.g... devices on an aircraft and providing for the intentional removal of a lithium ion battery from a device... limit lithium ion batteries used to power portable electronic devices and medical devices to 160 watt...

77 FR 72924 - Taxable Medical Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-07

... as devices by the FDA Center for Biologics Evaluation and Research (CBER). In general, CBER licenses... designed to implant a particular orthopedic joint; (iv) testing and development products; and (v) product...

77 FR 16925 - Medical Devices; Neurological Devices; Classification of the Near Infrared Brain Hematoma Detector

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-23

... Mitigation measures Excessive laser power Electrical safety and electromagnetic compatibility (EMC... should validate electromagnetic compatibility (EMC), electrical safety, and battery characteristics; (4...

21 CFR 862.3850 - Sulfonamide test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862... monitoring sulfonamide levels to ensure appropriate therapy. (b) Classification. Class I. [52 FR 16122, May 1...

75 FR 17511 - Coal Mine Dust Sampling Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-06

... Part III Department of Labor Mine Safety and Health Adminisration 30 CFR Parts 18, 74, and 75 Coal Mine Dust Sampling Devices; High-Voltage Continuous Mining Machine Standard for Underground Coal Mines...-AB61 Coal Mine Dust Sampling Devices AGENCY: Mine Safety and Health Administration, Labor. ACTION...

78 FR 15682 - Notification of Proposed Production Activity TTI, Inc.; Subzone 196A (Electromechanical and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-12

... Activity TTI, Inc.; Subzone 196A (Electromechanical and Circuit Protection Devices Production/ Kitting... electromechanical and circuit protection device production/kitting for a variety of commercial, aerospace and... for crimping, insertion/extraction, and terminal removal, and electromechanical devices (duty rates...

78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Device Good Manufacturing Practice Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Device Good Manufacturing Practice Advisory Committee. General Function of the Committee: To...

75 FR 34459 - Converged Communications and Health Care Devices Impact on Regulation; Public Meeting; Request...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-17

... established commercial communications networks such as Internet connectivity to communicate with care... stimulate muscle movement. Examples of devices and applications that use commercial communications networks...] Converged Communications and Health Care Devices Impact on Regulation; Public Meeting; Request for Comments...

77 FR 44671 - Certain Wireless Consumer Electronics Devices and Components Thereof; Notice of Receipt of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-30

... INTERNATIONAL TRADE COMMISSION [Docket No. 2904] Certain Wireless Consumer Electronics Devices and.... International Trade Commission has received a complaint entitled Certain Wireless Consumer Electronics Devices... importation, and the sale within the United States after importation of certain wireless consumer electronics...

77 FR 24738 - Certain Wireless Communication Devices and Systems, Components Thereof, and Products Containing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-25

... Devices and Systems, Components Thereof, and Products Containing Same; Notice of Commission Determination... certain wireless communication devices and systems, components thereof, and products containing the same..., California; Apple Inc. of Cupertino, California; Aruba Networks, Inc. of Sunnyvale, California; Meru Networks...

76 FR 69285 - Certain Game Devices, Components Thereof, and Products Containing the Same; Determination Not To...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-08

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-757] Certain Game Devices, Components Thereof, and Products Containing the Same; Determination Not To Review An Initial Determination Granting... the United States after importation of certain game devices, components thereof, and products...

77 FR 24716 - Scientific Information Request on Medical Devices To Treat Otitis Media With Effusion

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-25

... devices. Scientific information is being solicited to inform our Comparative Effectiveness Review of... scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-06

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

77 FR 32995 - Certain Electronic Imaging Devices Corrected: Notice of Receipt of Complaint; Solicitation of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-04

... INTERNATIONAL TRADE COMMISSION [Docket No. 2898] Certain Electronic Imaging Devices Corrected.... International Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Electronic Imaging Devices, DN 2898; the...

77 FR 8879 - Agency Information Collection Activities; Proposed Collection; Comment Request: Guidance for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-15

... Separator Device Operating by Centrifugal or Filtration Separation Principle AGENCY: Food and Drug... automated blood cell separator device operating by centrifugal or filtration separation principle. DATES... Filtration Separation Principle (OMB Control Number 0910-0594)--Extension Under the Safe Medical Devices Act...

78 FR 6750 - Revisions to the Export Administration Regulations (EAR): Articles the President Determines No...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-31

... vehicles, missiles, rockets, torpedoes, bombs, mines, and other military explosive devices enumerated in..., missiles, rockets, torpedoes, bombs, mines, other military explosive devices, and related articles, which... vehicles, missiles, rockets, torpedoes, bombs, mines, and other military explosive devices in USML Category...

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...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-30

...] Medical Device Epidemiology Network 2011: Second Annual Public Workshop AGENCY: Food and Drug... public workshop entitled ``Medical Device Epidemiology Network (MDEpiNet) 2011: Second Annual Public... and solicit feedback on the establishment of a network that works with FDA experts to determine the...

78 FR 41065 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-09

...] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third... notice solicits comments on the information collection associated with medical devices third-party review... that members of the public submit reports, keep records, or provide information to a third party...

75 FR 57801 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-22

...] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices Third... ``Medical Devices Third- Party Review under the Food and Drug Administration Modernization Act of 1997... that members of the public submit reports, keep records, or provide information to a third party...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-05

...] Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request for.... The Food and Drug Administration (FDA) is announcing the following public workshop entitled ``Battery... create awareness of the challenges related to battery-powered medical devices and collaboratively develop...

78 FR 23593 - Certain Mobile Electronic Devices Incorporating Haptics; Termination of Investigation

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-19

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-834] Certain Mobile Electronic Devices... this investigation may be viewed on the Commission's electronic docket (EDIS) at http://edis.usitc.gov... mobile electronic devices incorporating haptics that infringe certain claims of six Immersion patents. 77...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-16

... techniques, when appropriate, and other forms of information technology. Medical Device Recall Authority--21...] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Recall... information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required...

77 FR 26041 - Certain Computers and Computer Peripheral Devices and Components Thereof and Products Containing...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-02

... INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-841] Certain Computers and Computer Peripheral... after importation of certain computers and computer peripheral devices and components thereof and... computers and computer peripheral devices and components thereof and products containing the same that...

78 FR 43887 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-22

... manufacturers and applicable group purchasing organizations (GPOs) of covered drugs, devices, biologicals, or..., applicable manufacturers of covered drugs, devices, biologicals, and medical supplies are required to submit...

78 FR 22367 - Proposed Information Collection (Service Data Manual) Activity: Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-15

... technical medical equipment and devices or mechanical equipment. DATES: Written comments and recommendations... manuals and maintenance/repair manuals when technical medical equipment and devices, or mechanical...

78 FR 73475 - Defense Federal Acquisition Regulation Supplement: Clauses With Alternates-Research and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-06

... electromagnetic radiating device to the Contracting Officer during the initial planning, experimental, or... proposed electromagnetic radiating device to the Contracting Officer during the initial planning...

21 CFR 880.5680 - Pediatric position holder.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic... requirements concerning records, and § 820.198, with respect to complaint files. [45 FR 69682-69737, Oct. 21...

21 CFR 880.5680 - Pediatric position holder.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) MEDICAL DEVICES GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic... requirements concerning records, and § 820.198, with respect to complaint files. [45 FR 69682-69737, Oct. 21...

75 FR 28058 - In the Matter of Certain Digital Imaging Devices and Related Software; Notice of Investigation

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-19

... Devices and Related Software; Notice of Investigation AGENCY: U.S. International Trade Commission. ACTION... certain digital imaging devices and related software by reason of infringement of certain claims of U.S... digital imaging devices and related software that infringe one or more of claim 1-3 and 5-8 of U.S. Patent...

78 FR 20658 - Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-05

... Devices for Sterilization AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and... of information technology. Agreement for Shipment of Devices for Sterilization--21 CFR 801.150(e... commerce for sterilization at another establishment, a practice that facilitates the processing of devices...

77 FR 71804 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-04

... Representatives on the Device Good Manufacturing Practice Advisory Committee AGENCY: Food and Drug Administration... Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological... regarding good manufacturing practices governing the methods used in, and the facilities and controls used...

77 FR 14422 - Certain Consumer Electronics and Display Devices and Products Containing Same; Notice of Receipt...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-09

... INTERNATIONAL TRADE COMMISSION [DN 2882] Certain Consumer Electronics and Display Devices and... the U.S. International Trade Commission has received a complaint entitled Certain Consumer Electronics... importation of certain consumer electronics and display devices and products containing same. The complaint...

78 FR 71643 - Certain Wireless Consumer Electronics Devices and Components Thereof; Commission Determination To...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-29

... Electronics Devices and Components Thereof; Commission Determination To Review in Part A Final Initial... sale within the United States after importation of certain wireless consumer electronics devices and... Electronics, Inc. of Seoul, Korea and LG Electronics U.S.A., Inc. of Englewood Cliffs, New Jersey...

76 FR 72439 - Certain Consumer Electronics and Display Devices and Products Containing Same; Receipt of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-23

... INTERNATIONAL TRADE COMMISSION [DN 2858] Certain Consumer Electronics and Display Devices and.... International Trade Commission has received a complaint entitled In Re Certain Consumer Electronics and Display... importation of certain consumer electronics and display devices and products containing same. The complaint...

77 FR 31876 - Certain Consumer Electronics and Display Devices and Products Containing Same Determination Not...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-30

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-836] Certain Consumer Electronics and Display Devices and Products Containing Same Determination Not To Review Initial Determination To Amend... electronics and display devices and products containing the same by reason of infringement of U.S. Patent Nos...

78 FR 34664 - Prospective Grant of Start-up Exclusive Evaluation License: Portable Device and Method for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Start-up Exclusive Evaluation License: Portable Device and Method for Detecting Hematomas AGENCY: National... device and method for detecting hematomas based on near infrared light emitted perpendicularly into a...

77 FR 17457 - Work Group on Alternative Test Methods for Commercial Measuring Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-26

... Test Methods for Commercial Measuring Devices AGENCY: National Institute of Standards and Technology... Work Group (WG) to examine alternative methods for testing the accuracy of commercial measuring devices... participates to promote uniformity among the states in laws, regulations, methods, and testing equipment that...

77 FR 49458 - Certain Mobile Electronic Devices Incorporating Haptics; Amendment of the Complaint and Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-16

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-834] Certain Mobile Electronic Devices.... 1337 in the importation, sale for importation, and sale within the United States after importation of certain mobile electronic devices incorporating haptics, by reason of the infringement of claims of six...

76 FR 38417 - In the Matter of Certain Multimedia Display and Navigation Devices and Systems, Components...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-30

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-694] In the Matter of Certain Multimedia Display and Navigation Devices and Systems, Components Thereof, and Products Containing Same; Notice of... importation of certain multimedia display and navigation devices and systems, components thereof, and products...

76 FR 25707 - In The Matter of Certain Multimedia Display and Navigation Devices and Systems, Components...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-05

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-694] In The Matter of Certain Multimedia Display and Navigation Devices and Systems, Components Thereof, and Products Containing Same; Notice of... multimedia display and navigation devices and systems, components thereof, and products containing same by...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-05

...] Medical Device Quality System Regulation Educational Forum on Risk Management Through the Product Life...), is announcing a public workshop entitled ``Medical Device Quality System Regulation Educational Forum on Risk Management through the Product Life Cycle.'' This public workshop is intended to provide...

78 FR 18988 - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-28

...] Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to... announcing the availability of the guidance entitled ``Establishing the Performance Characteristics of In... document entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the...

76 FR 80947 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-27

... for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies... feasibility studies of medical devices, using appropriate risk mitigation strategies, under the... comments on the key principles unique to the justification for, and design of, early feasibility studies...

77 FR 27078 - Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-08

... Phones and Tablet Computers, and Components Thereof; Notice of Receipt of Complaint; Solicitation of... entitled Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof... the United States after importation of certain electronic devices, including mobile phones and tablet...

78 FR 47410 - Certain Wireless Devices, Including Mobile Phones and Tablets Institution of Investigation

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-05

... Mobile Phones and Tablets Institution of Investigation AGENCY: U.S. International Trade Commission... importation of certain wireless devices, including mobile phones and tablets by reason of infringement of... sale within the United States after importation of certain wireless devices, including mobile phones...

77 FR 31875 - Certain Electronic Imaging Devices; Notice of Receipt of Complaint; Solicitation of Comments...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-30

... INTERNATIONAL TRADE COMMISSION [Docket No. 2898] Certain Electronic Imaging Devices; Notice of... Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Electronic Imaging Devices, DN 2898; the Commission is...

78 FR 73563 - Certain Electronic Devices Having Placeshifting or Display Replication Functionality and Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-06

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-878] Certain Electronic Devices Having... AGENCY: U.S. International Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given that the U.S. International Trade Commission has issued (1) a limited exclusion order against infringing electronic devices...

76 FR 27331 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-11

... Characteristics of In Vitro Diagnostic Devices for Chlamydia Trachomatis and/or Neisseria Gonorrhoeae: Screening... entitled ``Establishing the Performance Characteristics of In Vitro Diagnostic Devices for Chlamydia... clinical performance of in vitro diagnostic devices (IVDs) intended for C. trachomatis and/or N...

78 FR 17429 - Certain Balloon Dissection Devices and Products Containing Same; Commission Determination Not To...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-21

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-865] Certain Balloon Dissection Devices... importation, or sale in the United States after importation of certain balloon dissection devices and products...; Pajunk Medizintechnologie GmbH of Geisingen, Germany; and Pajunk Medical Systems LP of Norcross, Georgia...

40 CFR 63.690 - Standards: Process vents.

Code of Federal Regulations, 2011 CFR

2011-07-01

....693 of this subpart. For the purpose of complying with this paragraph (b), a primary condenser is not a control device; however, a second condenser or other organic recovery device that is operated downstream of the primary condenser is considered a control device. [64 FR 38970, July 20, 1999] ...

76 FR 80402 - Certain Personal Data and Mobile Communications Devices and Related Software; Final Determination...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-23

... Communications Devices and Related Software; Final Determination Finding Violation of Section 337; Issuance of a... importation of infringing personal data and mobile communications devices and related software. The Commission... subsidiary NeXT Software, Inc., both of Cupertino, California (collectively, ``Apple''), alleging a violation...

77 FR 35427 - Certain Mobile Devices, Associated Software, and Components Thereof Final Determination of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-13

... Software, and Components Thereof Final Determination of Violation; Issuance of a Limited Exclusion Order... importation of certain mobile devices, associated software, and components thereof by reason of infringement... importation of certain mobile devices, associated software, and components thereof containing same by reason...

78 FR 1248 - Certain Computing Devices With Associated Instruction Sets and Software; Notice of Commission...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-08

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-812] Certain Computing Devices With Associated Instruction Sets and Software; Notice of Commission Determination Not To Review an Initial... devices with associated instruction sets and software by reason of infringement of claims 1-4, 7-10, and...

75 FR 8400 - In the Matter of Certain Wireless Communications System Server Software, Wireless Handheld...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-24

... Communications System Server Software, Wireless Handheld Devices and Battery Packs; Notice of Investigation..., wireless handheld devices and battery packs by reason of infringement of certain claims of U.S. Patent Nos... certain wireless communications system server software, wireless handheld devices or battery packs that...

78 FR 31576 - Enforcement Proceeding; Certain Two-Way Global Satellite Communication Devices, System and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-24

...-Way Global Satellite Communication Devices, System and Components Thereof; Notice of Institution of...-confidential documents filed in connection with this investigation are or will be available for inspection... importation of certain two-way global satellite communication devices, system and components thereof by reason...

78 FR 58785 - Unique Device Identification System

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-24

... to submitting a report. It will allow FDA, health care providers, and industry to more rapidly...-sustaining. Under the UDI system established by this rule, the health care community and the public will be... with any similar device which might lead to misuse of the device. Health care providers will no longer...

76 FR 46213 - National Standards for Traffic Control Devices; the Manual on Uniform Traffic Control Devices for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-02

... design and application of traffic control devices, this Manual should not be considered a substitute for... retroreflectivity of longitudinal pavement markings. The deadline for comments to that docket has passed and the... the proposed revisions regarding maintaining minimum retroreflectivity of longitudinal pavement...

78 FR 2912 - Prohibition on Personal Use of Electronic Devices on the Flight Deck

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-15

....C. 332(c)(7)(C)(i). In general, wireless telecommunications is the transfer of information between... personal wireless communications device or laptop computer for personal use while at their duty station on.... Personal Wireless Communications Device IV. Regulatory Notices and Analyses A. Regulatory Evaluation B...

78 FR 68861 - Certain Navigation Products, Including GPS Devices, Navigation and Display Systems, Radar Systems...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-15

... Devices, Navigation and Display Systems, Radar Systems, Navigational Aids, Mapping Systems and Related... navigation products, including GPS devices, navigation and display systems, radar systems, navigational aids..., radar systems, navigational aids, mapping systems and related software by reason of infringement of one...

78 FR 58545 - Global Unique Device Identification Database; Draft Guidance for Industry; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-24

...] Global Unique Device Identification Database; Draft Guidance for Industry; Availability AGENCY: Food and... the availability of the draft guidance entitled ``Global Unique Device Identification Database (GUDID... manufacturer) will interface with the GUDID, as well as information on the database elements that must be...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-28

... Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug... for 11 neurological and physical medicine devices. FDA is reopening the comment period to allow... announcing the availability of draft special controls guidance documents for 11 neurological and physical...

76 FR 31983 - In the Matter of Certain Electronic Devices, Including Mobile Phones, Portable Music Players, and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-02

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-701] In the Matter of Certain Electronic Devices, Including Mobile Phones, Portable Music Players, and Computers; Notice of Commission... States after importation of certain electronic devices, including mobile phones, portable music players...

77 FR 42502 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-19

...; Survey of ``Health Care Providers' Responses to Medical Device Labeling'' AGENCY: Food and Drug... collection of information entitled Survey of ``Health Care Providers' Responses to Medical Device Labeling... of information entitled Survey of ``Health Care Providers' Responses to Medical Device Labeling'' to...

78 FR 12664 - Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-25

... Clinical Studies for Medical Devices AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule... data from clinical studies for medical devices. We are proposing to require that clinical studies... the study by an independent ethics committee (IEC) and obtaining and documenting freely given informed...

25 CFR 226.36 - Control devices.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 25 Indians 1 2014-04-01 2014-04-01 false Control devices. 226.36 Section 226.36 Indians BUREAU OF... AND GAS MINING Requirements of Lessees § 226.36 Control devices. In drilling operations in fields... operations to maintain proper control of subsurface strata. [55 FR 33116, Aug. 14, 1990] ...

25 CFR 226.36 - Control devices.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 25 Indians 1 2010-04-01 2010-04-01 false Control devices. 226.36 Section 226.36 Indians BUREAU OF... AND GAS MINING Requirements of Lessees § 226.36 Control devices. In drilling operations in fields... operations to maintain proper control of subsurface strata. [55 FR 33116, Aug. 14, 1990] ...

25 CFR 226.36 - Control devices.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 25 Indians 1 2011-04-01 2011-04-01 false Control devices. 226.36 Section 226.36 Indians BUREAU OF... AND GAS MINING Requirements of Lessees § 226.36 Control devices. In drilling operations in fields... operations to maintain proper control of subsurface strata. [55 FR 33116, Aug. 14, 1990] ...

78 FR 66940 - Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-1295] Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft Guidance for... draft guidance entitled ``Regulatory Requirements for Hearing Aid Devices and Personal Sound...

75 FR 47819 - Workshop on Optimizing Clinical Trial Design for the Development of Pediatric Cardiovascular Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-09

...] Workshop on Optimizing Clinical Trial Design for the Development of Pediatric Cardiovascular Devices AGENCY... (AAP), the American College of Cardiology (ACC), and the Society for Cardiovascular Angiography and... Development of Pediatric Cardiovascular Devices.'' The topic to be discussed is pediatric cardiovascular...

77 FR 30368 - Defense Federal Acquisition Regulation Supplement; Utilization of Domestic Photovoltaic Devices...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-22

... objective of the rule is to promote utilization of domestic photovoltaic devices under energy savings... 0750-AH43 Defense Federal Acquisition Regulation Supplement; Utilization of Domestic Photovoltaic... Authorization Act for Fiscal Year 2011. The section provides that photovoltaic devices to be utilized in...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001... Products Development is announcing the following workshop: FDA Pediatric Medical Devices Workshop. This meeting is intended to focus on challenges in pediatric device development--namely, business planning and...

76 FR 73676 - Certain Dynamic Random Access Memory Devices, and Products Containing Same; Receipt of Complaint...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-29

... INTERNATIONAL TRADE COMMISSION [DN 2859] Certain Dynamic Random Access Memory Devices, and.... International Trade Commission has received a complaint entitled In Re Certain Dynamic Random Access Memory... certain dynamic random access memory devices, and products containing same. The complaint names Elpida...

76 FR 28787 - Agency Forms Undergoing Paperwork Reduction Act Review

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-18

.... Proposed Project Respiratory Protective Devices--42 CFR part 84--Regulation 0920- 0109- Extension--National...). Background and Brief Description This data collection was formerly named Respiratory Protective Devices 30... respiratory protective devices is found in the Mine Safety and Health Amendments Act of 1977 (30 U.S.C. 577a...

78 FR 77209 - Accessibility of User Interfaces, and Video Programming Guides and Menus

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-20

... user interfaces on digital apparatus and video programming guides and menus on navigation devices for... apparatus and navigation devices used to view video programming. The rules we adopt here will effectuate...--that is, devices and other equipment used by consumers to access multichannel video programming and...

78 FR 5327 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-25

... Agency) is proposing to classify the scleral plug into class II (special controls), and proposing to... controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval...

78 FR 19271 - Special Fraud Alert: Physician-Owned Entities

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-29

... selling, or arranging for the sale of, implantable medical devices ordered by their physician-owners for..., implantable medical devices ordered by their physician-owners for use in procedures the physician-owners... medical device manufacturers and distributors in an October 6, 2006 letter.\\3\\ In that letter, we noted...

77 FR 4059 - Certain Electronic Devices for Capturing and Transmitting Images, and Components Thereof; Receipt...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-26

... Images, and Components Thereof; Receipt of Complaint; Solicitation of Comments Relating to the Public... Devices for Capturing and Transmitting Images, and Components Thereof, DN 2869; the Commission is... importation of certain electronic devices for capturing and transmitting images, and components thereof. The...

77 FR 60721 - Certain Semiconductor Integrated Circuit Devices and Products Containing Same; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-04

... Circuit Devices and Products Containing Same; Notice of Commission Determination Not To Review an Initial... public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at http... certain semiconductor integrated circuit devices and products containing same by reason of infringement of...

77 FR 19032 - Certain Semiconductor Integrated Circuit Devices and Products Containing Same Notice of Receipt...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-29

... INTERNATIONAL TRADE COMMISSION [DN 2888] Certain Semiconductor Integrated Circuit Devices and... Integrated Circuit Devices and Products Containing Same, DN 2888; the Commission is soliciting comments on... Commission's electronic docket (EDIS) at http://edis.usitc.gov , and will be available for inspection during...

78 FR 55294 - Certain Wireless Devices With 3G Capabilities and Components Thereof Commission Determination To...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-10

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-800] Certain Wireless Devices With 3G Capabilities and Components Thereof Commission Determination To Review the Final Initial Determination Finding... importation of certain wireless devices with 3G capabilities and components thereof by reason of infringement...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-27

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

78 FR 104 - Advisory Committees; Tentative Schedule of Meetings for 2013

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-02

... Date(s), if needed, to be Committee. determined. Peripheral and Central Nervous System May 22. Drugs... be Devices Panel. determined. Circulatory System Devices Panel....... May 17, May 24, June 27...

21 CFR 880.2930 - Apgar timer.

Code of Federal Regulations, 2011 CFR

2011-04-01

... GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Monitoring Devices § 880.2930... requirements concerning records, and § 820.198 of this chapter, with respect to complaint files. [63 FR 59718...

21 CFR 880.2930 - Apgar timer.

Code of Federal Regulations, 2010 CFR

2010-04-01

... GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Monitoring Devices § 880.2930... requirements concerning records, and § 820.198 of this chapter, with respect to complaint files. [63 FR 59718...

76 FR 50663 - Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-16

... completion of a PDP is not filed by the latter of the two dates, and no IDE is in effect, the device is... availability of a preamendments class III devices strategy document. The strategy document set forth FDA's... approved PMA or a declared completed PDP is required to be in effect for any such devices on or before 180...

78 FR 8191 - Certain Wireless Devices With 3G and/or 4G Capabilities and Components Thereof; Institution of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-05

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-868] Certain Wireless Devices With 3G and... importation, and the sale within the United States after importation of certain wireless devices with 3G and... devices with 3G and/or 4G capabilities and components thereof by reason of infringement of one or more of...

75 FR 27264 - Video Device Competition; Implementation of Section 304 of the Telecommunications Act of 1996...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-14

... and Consumer Electronics Equipment AGENCY: Federal Communications Commission. ACTION: Notice of... explore the potential for allowing any electronics manufacturer to offer smart video devices at retail...

21 CFR 862.1710 - Total triiodothyronine test system.

Code of Federal Regulations, 2010 CFR

2010-04-01

... subpart E of part 807 of this chapter subject to the limitations in § 862.9. [52 FR 16122, May 1, 1987, as... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Chemistry Test...

76 FR 81363 - Temperature-Indicating Devices; Thermally Processed Low-Acid Foods Packaged in Hermetically...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-28

... Foods Packaged in Hermetically Sealed Containers; Correction AGENCY: Food and Drug Administration, HHS... containers to allow for use of other temperature-indicating devices, in addition to mercury-in-glass...

78 FR 49529 - Radio Frequency Wireless Technology in Medical Devices; Guidance for Industry and Food and Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-14

..., including selection of wireless technology, quality of service, coexistence, security, and electromagnetic... is an increasing concern because the electromagnetic environments where medical devices are used...

76 FR 18247 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-01

... Certain Electronic Devices, Including Mobile Phones, Mobile Tablets, Portable Music Players, and Computers... importation of certain electronic devices, including mobile phones, mobile tablets, portable music players...

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...

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...

76 FR 67465 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-01

... makes appropriate recommendations to the Commissioner. E. Molecular and Clinical Genetics Devices Panel... vitro devices for use in clinical laboratory medicine, including clinical and molecular genetics, and...

77 FR 31022 - Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-24

... development process as possible, of promising new devices to patients with life-threatening or serious... diligence in obtaining marketing clearance of the device and to ensure the integrity of the controlled...

78 FR 79304 - Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-30

... diabeticorum; Venous diseases, including the following: Prophylaxis of deep vein thrombophlebitis, edema (e.g..., edema (e.g., chronic lymphedema) and/or induration (e.g., stasis dermatitis) associated with chronic...

49 CFR 178.337-10 - Accident damage protection.

Code of Federal Regulations, 2010 CFR

2010-10-01

... failure of the sacrificial device must leave the protected lading protection device and its attachment to the cargo tank wall intact and capable of retaining product. [Order 59-B, 30 FR 581, Jan. 16, 1965...

75 FR 21631 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

... Request; Agreement for Shipment of Devices for Sterilization AGENCY: Food and Drug Administration, HHS.... Agreement for Shipment of Devices for Sterilization--21 CFR 801.150(e) (OMB Control Number 0910-0131... sterile at one establishment and ship the devices in interstate commerce for sterilization at another...

78 FR 43262 - Use of Wireless Mobile Data Devices as Transponders for the Commercial Motor Vehicle Information...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-19

... Data Devices as Transponders for the Commercial Motor Vehicle Information Systems and Networks (CVISN...; announcement of policy. SUMMARY: FMCSA announces that Commercial Mobile Radio Services (CMRS) network devices... information between the driver and the inspection site as the dedicated short-range communication (DSRC...

78 FR 56245 - Certain Wireless Consumer Electronics Devices and Components Thereof; Notice of Request for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-12

... Electronics Devices and Components Thereof; Notice of Request for Statements on the Public Interest AGENCY: U... wireless consumer electronics devices and components thereof imported by respondents Acer, Inc. of Taipei... Communications, Inc. of San Diego, California; LG Electronics, Inc. of Seoul, Korea; LG Electronics U.S.A., Inc...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-29

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

77 FR 66848 - Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-07

... trials and device study design. Date and Time: The public workshop will be held on November 27, 2012... problem for PRO instruments. There have been various methodological approaches to determine MCID for... rationales for regulatory guidance of clinical trials and device study design. Approximately 45 days after...

77 FR 5275 - Certain Ink Application Devices and Components Thereof and Methods of Using the Same; Receipt of...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-02

... INTERNATIONAL TRADE COMMISSION [DN 2874] Certain Ink Application Devices and Components Thereof... the U.S. International Trade Commission has received a complaint entitled In Re Certain Ink... United States after importation of certain ink application devices and components thereof and methods of...

77 FR 10559 - Agency Information Collection Activities: Proposed collection; comments requested: Certification...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-22

... Secure Gun Storage or Safety Devices ACTION: 60-Day notice of information collection. The Department of...) Title of the Form/Collection: Certification of Secure Gun Storage or Safety Devices. (3) Agency form... gun storage or safety devices. (5) An estimate of the total number of respondents and the amount of...

21 CFR 872.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... for human use that are in commercial distribution. (b) The identification of a device in a regulation... types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed in one... on the Internet at http://www.fda.gov/cdrh.guidance.html. [52 FR 30097, Aug. 12, 1987, as amended at...

21 CFR 890.1 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... medicine devices intended for human use that are in commercial distribution. (b) The identification of a... device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic... referenced in this part are available on the Internet at http://www.fda.gov/cdrh/guidance.html. [52 FR 17741...

75 FR 59746 - Criminal Division; Agency Information Collection Activities: Proposed Collection; Comments Requested

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-28

... Review: Request for Registration Under the Gambling Devices Act of 1962. The Department of Justice (DOJ..., Gambling Device Registration Program, JCK Building, Room 1040, Washington, DC 20530-0001. Written comments... the Gambling Devices Act of 1962. (3) Agency form number, if any, and the applicable component of the...

78 FR 52219 - State of Georgia Relinquishment of Sealed Source and Device Evaluation and Approval Authority

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-22

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0196] State of Georgia Relinquishment of Sealed Source and... evaluate and approve sealed source and device (SS&D) applications in the State of Georgia and approved the... regulatory authority for evaluating and approving sealed source and device applications on August 20, 2013...

76 FR 28688 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-18

... Controls Guidance Document: In Vitro Diagnostic Devices for Bacillus Species Detection AGENCY: Food and... Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. Detection.'' This draft guidance document describes means by which in vitro diagnostic devices for Bacillus species (spp.) detection may comply with...

75 FR 24960 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-06

..., to permit the use of investigational in vitro diagnostic devices to identify chemical, biological... consent is required for the use of an investigational in vitro diagnostic device. This exception will apply to those situations in which the in vitro investigational diagnostic device is used to prepare for...

75 FR 21567 - Federal Motor Vehicle Safety Standard No. 108; Lamp, Reflective Devices and Associated Equipment...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-26

... Federal Motor Vehicle Safety Standard No. 108; Lamp, Reflective Devices and Associated Equipment; Denial... Motor Vehicle Safety Standard (FMVSS) No. 108; Lamps, reflective devices, and associated equipment... physical filaments in the lamp. Specifically, BMW requested that paragraph S10.17.1.1.2 \\4\\ of the...

78 FR 6835 - Certain Mobile Handset Devices and Related Touch Keyboard Software; Institution of Investigation

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-31

... Related Touch Keyboard Software; Institution of Investigation AGENCY: U.S. International Trade Commission... importation of certain mobile handset devices and related touch keyboard software by reason of infringement of... certain mobile handset devices and related touch keyboard software that infringe one or more of claims 36...

75 FR 59670 - Immunology and Microbiology Devices; Reclassification of the Herpes Simplex Virus Serological...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2010-N-0429] Immunology and Microbiology Devices; Reclassification of the Herpes Simplex Virus... proposed that 21 CFR part 866 be amended as follows: PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES 1. The...

76 FR 48715 - Immunology and Microbiology Devices; Reclassification of the Herpes Simplex Virus Serological...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2010-N-0429] Immunology and Microbiology Devices; Reclassification of the Herpes Simplex Virus... CFR part 866 is amended as follows: PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES 0 1. The authority...

76 FR 70150 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-10

... proof of principle and initial clinical safety data before the device design is finalized. This draft... to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.... Early feasibility studies allow for early clinical evaluation of devices to provide proof of principle...

76 FR 51978 - Unlicensed Operation in the TV Broadcast Bands

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-19

... wireless devices in the TV spectrum. FOR FURTHER INFORMATION CONTACT: Hugh L. Van Tuyl at (202) 418-7056 or... will enable the introduction of this new class of unlicensed broadband wireless devices in the TV... wireless devices that can operate in broadcast television spectrum at locations where that spectrum is...

76 FR 70117 - Notice of Intent To Grant an Exclusive License; Voltage Networking, LLC

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-10

... dielectric layer and device made therefrom''; Patent No. 6,541,288 entitled ``Method of determining... sacrificial spacer layer''; Patent No. 7,442,577 entitled ``Method of fabricating a patterned device using sacrificial spacer layer''; Patent No. 7,678,593 entitled ``Method of fabricating optical device using...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-12

... reduce the risk of life-threatening bleeding events in patients with non-valvular atrial fibrillation who... premarket approval application regarding the Boston Scientific WATCHMAN Left Atrial Appendage (LAA) Closure... placed in the left atrial appendage. This device is intended to prevent thrombus embolization from the...

76 FR 59704 - Agency Information Collection Activities; Proposed Collection; Comment Request; Prominent and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-27

... Mark of Manufacturers on Single-Use Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice... single-use device labeling. DATES: Submit either electronic or written comments on the collection of... Single-Use Devices (OMB Control Number 0910-0577)--Extension Section 502 of the Federal Food, Drug, and...

76 FR 51038 - Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-17

...; formerly Docket No. 2007D-0290] Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells; Withdrawal of Draft Guidance...: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-20

... and it is identified as a device using focused ultrasound to produce localized, mechanical motion... labeling includes warnings related to patient reaction in terms of pain and information to user in terms of observable skin reactions that are known to be precursors to the potential thermal adverse effects...

76 FR 23923 - Hazardous Materials: Restricting the Use of Cellular Phones by Drivers of Commercial Motor...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-29

... associated with the use of cellular (mobile) phones and electronic devices while operating a commercial motor... mobile communication device that falls under or uses any commercial mobile radio service, as defined in... restricting the use of mobile telephones and other distracting electronic devices by railroad operating...

75 FR 61793 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-06

... to Amend FINRA Rule 8210 to Require Information Provided via Portable Media Device be Encrypted... to require that information provided via a portable media device pursuant to a request under the rule..., persons often provide information in electronic format using a portable media device such as a CD-ROM, DVD...

75 FR 52294 - Effective Date of Requirement for Premarket Approval for Four Class III Preamendments Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-25

... Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the... could lead to potentially debilitating or fatal thromboembolism. b. Excessive hemolysis--poor design of the hemodynamic characteristics of the device can lead to excess hemolysis. c. Inability to support...

76 FR 6623 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0066] Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Molecular and Clinical Genetics Panel of the Medical Devices Advisory...

77 FR 5058 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Automatic...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-01

... for OMB Review; Comment Request; Automatic Fire Sensor and Warning Devices Systems; Examination and..., ``Automatic Fire Sensor and Warning Devices Systems,'' to the Office of Management and Budget (OMB) for review... and warning device systems are maintained and calibrated in order to function properly at all times...

78 FR 19606 - Energy Conservation Program for Consumer Products: Test Procedures for Residential Furnace Fans

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-02

... electrically-powered devices used in central HVAC systems for the purposes of circulating air through ductwork...- powered device used in a central HVAC system for the purpose of circulating air through ductwork. DOE... included single-phase, electrically-powered devices that circulate air through ductwork in HVAC systems...

78 FR 29392 - Embedded Digital Devices in Safety-Related Systems, Systems Important to Safety, and Items Relied...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-20

... NUCLEAR REGULATORY COMMISSION [NRC-2013-0098] Embedded Digital Devices in Safety-Related Systems... (NRC) is issuing for public comment Draft Regulatory Issue Summary (RIS) 2013-XX, ``Embedded Digital... requirements for the quality and reliability of basic components with embedded digital devices. DATES: Submit...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-21

... premarket approval application, sponsored by Torax Medical, Inc., for the LINX Reflux Management System, a sterile, single use, surgically placed device used to treat the symptoms associated with gastroesophageal reflux disease. FDA intends to make background material available to the public no later than 2 business...

76 FR 4375 - In the Matter of Certain MLC Flash Memory Devices and Products Containing Same; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-25

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-683] In the Matter of Certain MLC Flash Memory Devices and Products Containing Same; Notice of Commission Determination Not To Review an Initial... the United States after importation of certain MLC flash memory devices and products containing same...

78 FR 64534 - Certain Ink Application Devices and Components Thereof and Methods of Using the Same Commission...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-29

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-832] Certain Ink Application Devices and..., and the sale within the United States after importation of certain ink application devices and... or, in the alternative, granting Complainants' motion for an ID finding T-Tech in default pursuant to...

75 FR 47027 - In the Matter of: Certain Devices Having Elastomeric Gel and Components Thereof; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-04

... Elastomeric Gel and Components Thereof; Notice of Investigation AGENCY: U.S. International Trade Commission... importation, and the sale within the United States after importation of certain devices having elastomeric gel... after importation of certain devices having elastomeric gel and components thereof that infringe one or...

78 FR 53002 - Notice of Proposed Buy America Waiver for a Video Ready Access Device Cabinet

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-27

... DEPARTMENT OF TRANSPORTATION Federal Transit Administration [Docket No. FTA-2013-0035] Notice of Proposed Buy America Waiver for a Video Ready Access Device Cabinet AGENCY: Federal Transit Administration... rules for a Video Ready Access Device (VRAD) cabinet. The VRAD cabinet is needed for an AT&T utility...

78 FR 76710 - Notice of Buy America Waiver for a Video Ready Access Device Cabinet

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-18

... Buy America Waiver for a Video Ready Access Device Cabinet AGENCY: Federal Transit Administration, DOT... America waiver for a Video Ready Access Device (VRAD) cabinet, the Federal Transit Administration (FTA... Transit Administration (FTA) has granted a non- availability waiver for the procurement of a Video Ready...

78 FR 29141 - Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and FDA Staff...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0893] Center for Devices and Radiological Health Appeals Processes; Guidance for Industry and FDA Staff... Administration (FDA) is announcing the availability of the guidance entitled ``Center for Devices and...

78 FR 68459 - Medical Device Development Tools; Draft Guidance for Industry, Tool Developers, and Food and Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-14

... Radiological Health (CDRH) for qualification of medical device development tools (MDDT) for use in device.... Background The draft guidance describes the framework and process for the voluntary CDRH qualification of... science; and (4) more quickly and more clearly communicate with CDRH stakeholders about important advances...

77 FR 45927 - Implementation of Device Registration and Listing Requirements Enacted in the Public Health...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-02

... example, this information could be used to address a device shortage in an emergency. (Comment 5) One... information to accomplish a number of important statutory and regulatory objectives. For example, we use... needed most. For example, during a bioterrorism incident, we could use device listing information to...

75 FR 70271 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-17

...: Non-Powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy; Availability AGENCY...-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT).'' This guidance document describes a means by which non-powered suction apparatus devices intended for NPWT may comply with...

76 FR 6551 - Medical Devices; General and Plastic Surgery Devices; Classification of Contact Cooling System...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-07

... intended for non-invasive aesthetic use will need to address the issues covered in the special controls... intended for non-invasive aesthetic use. (b) Classification. Class II (special controls). The special... into class II (special controls). The special control that will apply to the device is the guidance...

78 FR 53151 - The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-28

... research and marketing applications for medical devices. This draft guidance is not final nor is it in... FDA-regulated products (21 CFR 58.1). The draft guidance provides clarification on GLP terminology, the types of medical device research or marketing applications that are subject to the GLP regulation...

78 FR 42107 - Certain Wireless Devices With 3G Capabilities and Components Thereof; Notice of Request for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-15

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-800] Certain Wireless Devices With 3G Capabilities and Components Thereof; Notice of Request for Statements on the Public Interest AGENCY: U.S..., specifically a limited exclusion order against certain wireless devices with 3G capabilities and components...

77 FR 26788 - Certain Wireless Devices With 3G Capabilities and Components Thereof Determination Not To Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-07

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-800] Certain Wireless Devices With 3G Capabilities and Components Thereof Determination Not To Review Initial Determination To Amend the Notice of... importation of certain wireless devices with 3G capabilities and components thereof by reason of infringement...

76 FR 81527 - Certain Wireless Devices with 3G Capabilities and Components Thereof; Determination Not to Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-28

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-800] Certain Wireless Devices with 3G Capabilities and Components Thereof; Determination Not to Review Initial Determination Granting Motion for... importation, and the sale within the United States after importation of certain wireless devices with 3G...

30 CFR 75.1908 - Nonpermissible diesel-powered equipment; categories.

Code of Federal Regulations, 2013 CFR

2013-07-01

... the mine fire fighting and evacuation plan under § 75.1502. [61 FR 55527, Oct. 25, 1996; 70 FR 36347... such machine or device, which job site is occupied by a miner. (d) Diesel-powered ambulances and fire...

75 FR 82410 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-30

... Certain Game Devices, Components Thereof, and Products Containing the Same, DN 2776; the Commission is... United States after importation of certain game devices, components thereof, and products containing the...

78 FR 59370 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-26

... Certain Marine Sonar Imaging Devices, Products Containing the Same, and Components Thereof, DN 2981; the... United States after importation of certain marine sonar imaging devices, products containing the same...

75 FR 9416 - Advisory Committee Information Hotline

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-02

... Drugs Advisory Committee 3014512542 Peripheral and Central Nervous System Drugs Advisory Committee... Devices Panel 3014512624 Circulatory System Devices Panel 3014512625 Clinical Chemistry and Clinical... about any particular advisory committee meeting, this system will provide interested parties with timely...

78 FR 77689 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-24

... fibrosis, fluoride uptake acceleration in dentistry, and for local anesthesia of the intact tympanic... cystic fibrosis, application of fluoride in dentistry, or anesthetizing the tympanic membrane. Based on...

78 FR 2437 - Corrected: Certain Cases For Portable Electronic Devices; Notice of Receipt of Complaint...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-11

... cases for portable electronic devices. The complaint names as respondents Global Digital Star Industry... the United States, competitive conditions in the United States economy, the production of like or...

77 FR 74197 - Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-13

... section entitled ``Agenda'', the product name ``NeuroPace Responsive Neurostimulation (RNS) System'' is corrected to read ``NeuroPace RNS System''. Dated: December 7, 2012. Jill Hartzler Warner, Acting Associate...

78 FR 28733 - Medical Devices; General Hospital and Personal Use Monitoring Devices; Classification of the...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-16

... Toxicology Testing. Labeling (dose limits). Electromagnetic incompatibility........ Electromagnetic... analysis and nonclinical testing must validate electromagnetic compatibility performance, wireless... electromagnetic compatibility performance, wireless performance, and electrical safety; and (4) Labeling must...

75 FR 66382 - Request for Notification From Industry Organizations Interested in Participating in the Selection...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-28

.... Therapy Devices Panel. General and Plastic Surgery Devices September 1, 2011. Panel. A. NMQAAC The... review and make recommendations on specific issues or problems concerning the safety and effectiveness of...

78 FR 1205 - Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Hydrographic Surveys

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-08

.... OCS operates active acoustic devices that have the potential to disturb marine mammals, and operates... surveys, OCS uses active acoustic devices, including some that may result in behavioral harassment of...

76 FR 43582 - Cardiovascular Devices; Classification of Electrocardiograph Electrodes

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 870 [Docket No. FDA-2007-N-0092] (Formerly Docket No. 2007N-0308) Cardiovascular Devices; Classification of... amended as follows: [[Page 43585

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-13

... committee regarding classification of triple chamber pacing system analyzers (PSAs) with external pacing... chamber PSA is intended to be used during the implant procedure of pacemakers and defibrillators...

78 FR 38867 - Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-28

... artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides... into the heart or blood vessel could damage tissues and result in injuries. Hemolysis. Turbulence or...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-05

... Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency... utilizes electromagnetic waves to characterize human tissue in real time and provides intraoperative...

76 FR 19998 - Supplemental Funding Under the Food and Drug Administration Pediatric Device Consortia Grant Program

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-11

... adults. Children differ from adults in terms of their size, growth, development, and body chemistry... devices designed specifically with children in mind. Such needs include the original development of...

76 FR 256 - Informed Consent Elements

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-04

... societies, trade organizations representing clinical research organizations, drug and device sponsors, blood banks, clinical research organizations, research hospitals, medical device manufacturers, nonprofit... Administration Amendments Act of 2007 (FDAAA) and is designed to promote transparency of clinical research to...

Image enhancement and quality measures for dietary assessment using mobile devices

NASA Astrophysics Data System (ADS)

Xu, Chang; Zhu, Fengqing; Khanna, Nitin; Boushey, Carol J.; Delp, Edward J.

2012-03-01

Measuring accurate dietary intake is considered to be an open research problem in the nutrition and health fields. We are developing a system, known as the mobile device food record (mdFR), to automatically identify and quantify foods and beverages consumed based on analyzing meal images captured with a mobile device. The mdFR makes use of a fiducial marker and other contextual information to calibrate the imaging system so that accurate amounts of food can be estimated from the scene. Food identification is a difficult problem since foods can dramatically vary in appearance. Such variations may arise not only from non-rigid deformations and intra-class variability in shape, texture, color and other visual properties, but also from changes in illumination and viewpoint. To address the color consistency problem, this paper describes illumination quality assessment methods implemented on a mobile device and three post color correction methods.

Image Enhancement and Quality Measures for Dietary Assessment Using Mobile Devices

PubMed Central

Xu, Chang; Zhu, Fengqing; Khanna, Nitin; Boushey, Carol J.; Delp, Edward J.

2016-01-01

Measuring accurate dietary intake is considered to be an open research problem in the nutrition and health fields. We are developing a system, known as the mobile device food record (mdFR), to automatically identify and quantify foods and beverages consumed based on analyzing meal images captured with a mobile device. The mdFR makes use of a fiducial marker and other contextual information to calibrate the imaging system so that accurate amounts of food can be estimated from the scene. Food identification is a difficult problem since foods can dramatically vary in appearance. Such variations may arise not only from non-rigid deformations and intra-class variability in shape, texture, color and other visual properties, but also from changes in illumination and viewpoint. To address the color consistency problem, this paper describes illumination quality assessment methods implemented on a mobile device and three post color correction methods. PMID:28572695

42 CFR 84.65 - Conduct of examinations, inspections, and tests by the Institute; assistance by applicant...

Code of Federal Regulations, 2012 CFR

2012-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES General... respiratory equipment as is deemed appropriate. [60 FR 30355, June 8, 1995, as amended at 77 FR 14193, Mar. 8...

42 CFR 84.65 - Conduct of examinations, inspections, and tests by the Institute; assistance by applicant...

Code of Federal Regulations, 2013 CFR

2013-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES General... respiratory equipment as is deemed appropriate. [60 FR 30355, June 8, 1995, as amended at 77 FR 14193, Mar. 8...

42 CFR 84.65 - Conduct of examinations, inspections, and tests by the Institute; assistance by applicant...

Code of Federal Regulations, 2014 CFR

2014-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES APPROVAL OF RESPIRATORY PROTECTIVE DEVICES General... respiratory equipment as is deemed appropriate. [60 FR 30355, June 8, 1995, as amended at 77 FR 14193, Mar. 8...

76 FR 51054 - In the Matter of Certain Liquid Crystal Display Devices and Products Containing the Same; Notice...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-17

.... 1337, based on a complaint filed by Samsung Electronics Co., Ltd. of Korea (``Samsung'') alleging a... FR 39897 (Jul. 7, 2011). Complainant Samsung named AU Optronics Corp. of Hsinchu, Taiwan; AU...

75 FR 384 - Event Problem Codes Web Site; Center for Devices and Radiological Health; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-05

...] Event Problem Codes Web Site; Center for Devices and Radiological Health; Availability AGENCY: Food and... the availability of a Web site where the Center for Devices and Radiological Health (CDRH) is posting... to all reporters (Sec. 803.21(b)). FDA is announcing the availability of a Web site that will make...

76 FR 17422 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-29

..., and vote on information related to the premarket approval application (PMA) for the Augment Bone Graft, sponsored by Biomimetic Therapeutics, Inc. The intended use of the device is as an alternative bone grafting substitute to autologous bone graft in applications to facilitate fusion in the ankle and foot without...

78 FR 28229 - Prospective Grant of Exclusive License: Device and System for Expression Microdissection (xMD)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-14

... applications and foreign counterparts to xMD Diagnostics, LLC, a company having a place of business in Maryland... limited to the following below. ``Devices, systems, kits and related consumables, and methods using.... Methods, kits, and related consumables that are used independent of the devices or systems by individual...

78 FR 958 - Certain Wireless Devices With 3G and/or 4G Capabilities and Components Thereof Notice of Receipt...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-07

... INTERNATIONAL TRADE COMMISSION [DN 2929] Certain Wireless Devices With 3G and/or 4G Capabilities... Interest AGENCY: U.S. International Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Wireless Devices...

75 FR 75696 - Criminal Division; Agency Information Collection Activities: Proposed Collection; Comments Requested

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-06

... Review: Request for Registration Under the Gambling Devices Act of 1962. The Department of Justice (DOJ.../Collection: Request for Registration Under the Gambling Devices Act of 1962. (3) Agency form number, if any... Government. The form can be used by any entity required to register under the Gambling Devices Act of 1962...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-16

... diverting cardiac output to the cerebral vasculature via partial occlusion of the descending aorta... inflation of the individual balloons. The device is placed in the descending aorta. On March 30, 2005, a... the descending aorta (K090970). CoAxia has submitted a de novo application for the NeuroFlo for the...

75 FR 71735 - In the Matter of: Certain Automated Media Library Devices; Notice of Investigation

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-24

... INTERNATIONAL TRADE COMMISSION [Inv. No. 337-TA-746] In the Matter of: Certain Automated Media... sale within the United States after importation of certain automated media library devices by reason of... after importation of certain automated media library devices that infringe one or more of claims 1-11 of...

76 FR 1169 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-07

... Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use AGENCY: Food and Drug... Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional... required for: (1) In vitro diagnostic devices (IVDs), intended for professional use under 21 CFR 809.10...

78 FR 76993 - Defense Federal Acquisition Regulation Supplement: Photovoltaic Devices (DFARS Case 2014-D006)

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-20

... (DFARS) to clarify rules of origin under trade agreements for photovoltaic devices to be utilized under.... 111-383) addresses the origin of photovoltaic devices purchased by a contractor under an energy... country of origin. DoD initially implemented this statute through an interim rule (DFARS Case 2011-D046...

14 CFR 121.407 - Training program: Approval of airplane simulators and other training devices.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 3 2014-01-01 2014-01-01 false Training program: Approval of airplane... Program § 121.407 Training program: Approval of airplane simulators and other training devices. Link to an amendment published at 78 FR 67836, Nov. 12, 2013. (a) Each airplane simulator and other training device...

75 FR 448 - In the Matter of: Certain Authentication Systems, Including Software and Handheld Electronic...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-05

... Systems, Including Software and Handheld Electronic Devices; Notice of Investigation AGENCY: U.S... software and handheld electronic devices, by reason of infringement of certain claims of U.S. Patent No 7... software and handheld electronic devices, that infringe one or more of claims 31-35, 38, 41, 51, 54, 56, 58...

75 FR 17434 - In the Matter of Certain Personal Data and Mobile Communications Devices and Related Software...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-06

... Mobile Communications Devices and Related Software; Notice of Investigation AGENCY: U.S. International... Apple Computer, Inc. of Cupertino, California and NeXT Software, Inc. f/k/a NeXT Computer, Inc. of... certain personal data and mobile communications devices and related software by reason of infringement of...

78 FR 36132 - National Standards for Traffic Control Devices; Manual on Uniform Traffic Control Devices for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-17

... traffic control devices used on all streets, highways, bikeways, and private roads open to public travel... restructuring the MUTCD into two documents at this time. FOR FURTHER INFORMATION CONTACT: For questions about... do this; however, it is unclear at this time where this material would be located. It could be...

78 FR 24426 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-25

... application for the Kineflex/C Cervical Artificial Disc sponsored by SpinalMotion. The Kineflex/C is a metal-on-metal (cobalt chrome molybdenum alloy) cervical total disc replacement device. The Kineflex/C is... degenerative disc disease (DDD) where DDD is defined as discogenic back pain with degeneration of the disc as...

75 FR 10294 - Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-05

...] Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public Meeting; Extension...). In the notice, FDA requested comments on a number of identified challenges associated with the 510(k... premarket notification (or 510(k)) process for the review of medical devices. Specific questions for comment...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-02

...] Medical Device User Fee Rates for Fiscal Year 2014 AGENCY: Food and Drug Administration, HHS. ACTION... procedures for medical device user fees for fiscal year (FY) 2014. The Federal Food, Drug, and Cosmetic Act.... The FY 2014 fee rates are provided in this document. These fees apply from October 1, 2013, through...

77 FR 1768 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-11

... Held Device--Opening and Closing Order Imbalances Only (Together the ``Hand Held Device Fees''), the... the NYSE e-Broker[supreg] Hand Held Device--Opening and Closing Order Imbalances Only (together the... Imbalances Only, the $1,000 per year fee for approval of a pre-qualified substitute, and the $250 per year...

75 FR 76015 - Compliance Policy Guide Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0551] Compliance Policy Guide Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture... Compliance Policy Guide Sec. 393.200 Laser(s) as Medical Devices for Facelift, Wrinkle Removal, Acupuncture...

78 FR 65339 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-31

... the applicant for marketing a particular medical device. A class III device that fails to meet PMA..., devices that were in commercial distribution before May 28, 1976, are not required to submit a PMA until... is labor-intensive to compile and complete; the remaining PMAs require minimal information. Based on...

76 FR 55417 - In the Matter of Certain Dynamic Random Access Memory and Nand Flash Memory Devices and Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-07

... Access Memory and Nand Flash Memory Devices and Products Containing Same; Notice of Institution of... importation, and the sale within the United States after importation of certain dynamic random access memory and NAND flash memory devices and products containing same by reason of infringement of certain claims...

76 FR 50230 - Center for Devices and Radiological Health 510(k) Clearance Process; Recommendations Proposed in...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-12

.... For those without Internet access, please call the contact person to register. Early registration is... access of medical devices to the market. On July 29, 2011, IOM released the report ``Medical Devices and..., and other relevant information will be posted, as it becomes available, on the Internet at http://www...

75 FR 24718 - Town Hall Discussion With the Director of the Center for Devices and Radiological Health and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-05

... Devices and Radiological Health (CDRH) fiscal year (FY) 2010 priorities. In addition, FDA is interested in... importance to the medical device industry. CDRH is specifically interested in addressing the following.... Background CDRH has announced four priority areas of activity for FY 2010, each of which presents significant...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-03

... medical devices regulated by the Center for Devices and Radiological Health (CDRH) and the Center for... assist that office in processing your request, or fax your request to CDRH at (301) 847-8149. The draft... parts 862 through 892)) have been the basis for the CDRH's Classification Product Code structure and...

78 FR 70306 - Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-25

... for Devices and Radiological Health (CDRH) Food and Drug Administration, 10903 New Hampshire Ave...''). This guidance is intended to provide the current thinking of CDRH and CBER on when IVD products are... capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/Device...

76 FR 61103 - Draft Guidance for Industry and Food and Drug Administration Staff; De Novo Classification...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-03

... all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationand...),'' from CDRH you may either send an e-mail request to [email protected] to receive an electronic copy of... guidance describes how FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-07

... meeting is regarding the discussion of different innovative methodological approaches to the conduct of postmarket studies regarding silicone gel breast implants. Additionally, the panel will discuss key long-term...

76 FR 41507 - Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-14

...., vaginal erosion leading to pelvic pain and dyspareunia, and available information on clinical benefit. The... consider surgical mesh used to treat stress urinary incontinence. FDA intends to make background material...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-14

... medical professionals. The database is a Web- based server that contains software, which receives data transmitted from the electronics unit, and presents the data for review by medical professionals. FDA intends...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-07

... recommendations and vote on information regarding the premarket approval application (PMA) for the NeuroPace Responsive Neurostimulation (RNS) System sponsored by NeuroPace, Inc. The RNS System is indicated for use as...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-28

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

77 FR 42503 - Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-19

... committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should... perception, the retina must be able to respond to electrical stimulation as evidenced by an electrically...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-19

... vote on information related to the PMA for the Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System sponsored by Cameron Health, Inc. The S-ICD is the first implantable defibrillator that...

76 FR 12742 - Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-08

... mechanical/hydraulic urinary continence devices; urological clamp for males; nonimplanted, peripheral and... intended to treat urinary incontinence. It does not create or confer any rights for or on any person and...

76 FR 54251 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-31

... Certain Digital Photo Frames and Image Display Devices and Components Thereof, DN 2842; the Commission is... importation of certain digital photo frames and image display devices and components thereof. The complaint...

77 FR 4219 - FAA-Approved Portable Oxygen Concentrators; Technical Amendment

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-27

...-1343; Amdt. No. 121-358] FAA-Approved Portable Oxygen Concentrators; Technical Amendment AGENCY... amending regulations relating to operating rules for FAA approved portable oxygen concentrators (POC... Certain Portable Oxygen Concentrator Devices Onboard Aircraft'' (70 FR 40156). SFAR 106 permits passengers...

Sleep restriction and degraded reaction-time performance in Figaro solo sailing races.

PubMed

Hurdiel, Rémy; Van Dongen, Hans P A; Aron, Christophe; McCauley, Peter; Jacolot, Laure; Theunynck, Denis

2014-01-01

In solo offshore sailing races like those of the Solitaire du Figaro, sleep must be obtained in multiple short bouts to maintain competitive performance and safety. Little is known about the amount of sleep restriction experienced at sea and the effects that fatigue from sleep loss have on sailors' performance. Therefore, we assessed sleep in sailors of yachts in the Figaro 2 Beneteau class during races and compared response times on a serial simple reaction-time test before and after races. Twelve men (professional sailors) recorded their sleep and measured their response times during one of the three single-handed races of 150, 300 and 350 nautical miles (nominally 24-50 h in duration). Total estimated sleep duration at sea indicated considerable sleep insufficiency. Response times were slower after races than before. The results suggest that professional sailors incur severe sleep loss and demonstrate marked performance impairment when competing in one- to two-day solo sailing races. Competitive performance could be improved by actively managing sleep during solo offshore sailing races.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-09

... measurements to a database for review by medical professionals. The database is a Web-based server that... review by medical professionals. FDA intends to make background material available to the public no later...

75 FR 181 - Notice of Determinations on the PURPA Standards Set Forth in the Energy Independence and Security...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-04

... consists of the intelligent electronic devices (IEDs) and communications between the devices for feedback... Equipment provisions in subsection C employ a rate of return perspective that applies to investor-owned...

76 FR 51876 - Medical Devices; Ophthalmic Devices; Classification of the Eyelid Thermal Pulsation System

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-19

... meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye. The system... evaporative dry eye or lipid deficiency dry eye. The system consists of a component that is inserted around...

76 FR 62306 - Countermeasures Injury Compensation Program (CICP): Administrative Implementation, Final Rule

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-07

... respirators, Respiratory support devices, Ventilators, Anthrax, Smallpox, Botulism, Acute radiation syndrome...] and Relenza[supreg] when used for pandemic purposes; (5) smallpox countermeasures; (6) acute radiation syndrome countermeasures; (7) pandemic influenza diagnostics, personal respiratory devices, and respiratory...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-18

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

78 FR 20268 - Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-04

... methods: Electronic Submissions Submit electronic comments in the following way: Federal eRulemaking... effectiveness of the device but does not include descriptions of methods of manufacture or product composition... scientific literature [[Page 20272

76 FR 64223 - Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-17

... arrhythmias; and 4. Micro/macro shocks--Uncontrolled leakage currents or patient auxiliary currents can cause...); Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996); and Riegel v. Medtronic, Inc. 128 S. Ct. 999 (2008)). If this...

75 FR 16391 - Limiting the Use of Wireless Communication Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-01

... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Parts 383, 384... Communication Devices AGENCY: Federal Motor Carrier Safety Administration, DOT. ACTION: Notice of proposed rulemaking; request for comments. SUMMARY: The Federal Motor Carrier Safety Administration (FMCSA) proposes...

75 FR 65378 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-22

... Certain Electronic Device Mixer Apparatus for use in the Audio Disc-Jockey Industry, DN 2761; the... within the United States after importation of certain electronic device mixer apparatus for use in the...

76 FR 45615 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-29

... Certain Wireless Devices with 3G Capabilities and Components Thereof, DN 2835; the Commission is... importation, and the sale within the United States after importation of certain wireless devices with 3g...

75 FR 74081 - In the Matter of Certain Mobile Devices and Related Software; Notice of Investigation

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-30

... Related Software; Notice of Investigation AGENCY: U.S. International Trade Commission. ACTION: Institution... certain mobile devices and related software by reason of infringement of certain claims of U.S. Patent No... mobile devices and related software that infringe one or more of claims 1, 2, 10, 11, 24-26 and 29 of the...

78 FR 42082 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-15

... Request; Agreement for Shipment of Devices for Sterilization AGENCY: Food and Drug Administration, HHS... review and clearance. Agreement for Shipment of Devices for Sterilization--21 CFR 801.150(e) (OMB Control... (the FD&C Act) (21 U.S.C. 351(c) and 352(a)), nonsterile devices that are labeled as sterile but are in...

76 FR 58301 - Proposed Extension of Existing Information Collection; Automatic Fire Sensor and Warning Device...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-20

.... Sec. 75.1103-8(b) and (c). MSHA expects to subsume these provisions into OMB 1219-0054, Fire....1103-5(a)(2)(ii) Automatic fire sensor and warning device systems and the package is at OMB for its 3.... 75.1103-5(a) Automatic fire warning devices; actions, response in October 2010; OMB 1219-0127...

10 CFR 36.1 - Purpose and scope.

Code of Federal Regulations, 2014 CFR

2014-01-01

... area subject to irradiation are contained within a device and are not accessible by personnel), medical radiology or teletherapy, radiography (the irradiation of materials for nondestructive testing purposes), gauging, or open-field (agricultural) irradiations. [58 FR 7728, Feb. 9, 1993, as amended at 78 FR 17007...

Dual lumen transducer probes for real-time 3-D interventional cardiac ultrasound.

PubMed

Lee, Warren; Idriss, Salim F; Wolf, Patrick D; Smith, Stephen W

2003-09-01

We have developed dual lumen probes incorporating a forward-viewing matrix array transducer with an integrated working lumen for delivery of tools in real-time 3-D (RT3-D) interventional echocardiography. The probes are of 14 Fr and 22 Fr sizes, with 112 channel 2-D arrays operating at 5 MHz. We obtained images of cardiac anatomy and simultaneous interventional device delivery with an in vivo sheep model, including: manipulation of a 0.36-mm diameter guidewire into the coronary sinus, guidance of a transseptal puncture using a 1.2-mm diameter Brockenbrough needle, and guidance of a right ventricular biopsy using 3 Fr biopsy forceps. We have also incorporated the 22 Fr probe within a 6-mm surgical trocar to obtain apical four-chamber ultrasound (US) scans from a subcostal position. Combining the imaging catheter with a working lumen in a single device may simplify cardiac interventional procedures by allowing clinicians to easily visualize cardiac structures and simultaneously direct interventional tools in a RT3-D image.

78 FR 27442 - Coal Mine Dust Sampling Devices; Correction

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-10

... DEPARTMENT OF LABOR Mine Safety and Health Administration Coal Mine Dust Sampling Devices; Correction AGENCY: Mine Safety and Health Administration, Labor. ACTION: Notice; correction. SUMMARY: On April 30, 2013, Mine Safety and Health Administration (MSHA) published a notice in the Federal Register...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-28

... (L2-S1) degenerative disc disease. FDA intends to make background material available to the public no... providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee...

78 FR 12354 - Certain Wireless Consumer Electronics Devices and Components Thereof; Commission Determination...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-22

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-853] Certain Wireless Consumer Electronics Devices and Components Thereof; Commission Determination Concerning an Initial Determination Granting a Motion To Amend Complaint and Notice of Investigation AGENCY: U.S. International Trade...

77 FR 11121 - Scientific Information Request on Treatment of Atrial Fibrillation

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-24

... fibrillation medical devices. Scientific information is being solicited to inform our Comparative Effectiveness... unpublished pertinent scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative...

75 FR 68200 - Medical Devices; Radiology Devices; Reclassification of Full-Field Digital Mammography System

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-05

... exposure control, image processing and reconstruction programs, patient and equipment supports, component..., acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and... may include was revised by adding automatic exposure control, image processing and reconstruction...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-07

... cardiac cycle. During diastole, the balloon will inflate, creating a rise in pressure in the aorta, thus..., deflation of the balloon causes a fall in pressure in the aorta, which assists the left ventricle by...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-31

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

76 FR 73677 - Investigations: Terminations, Modifications and Rulings: Certain Electronic Devices With Image...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-29

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-724] Investigations: Terminations, Modifications and Rulings: Certain Electronic Devices With Image Processing Systems, Components Thereof, and Associated Software AGENCY: U.S. International Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-04

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

76 FR 43689 - Draft Guidance for Industry and Food and Drug Administration Staff; Mobile Medical Applications...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-21

... infusion pump stand, which is currently classified as a class I device because it supports the intended use of an infusion pump (class II medical device). A mobile medical app that simply supports the intended...

76 FR 69274 - Draft Guidance for Industry and Food and Drug Administration Staff; 510(k) Device Modifications...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-08

... for Devices and Radiological Health (CDRH) guidance documents is available at http://www.fda.gov...'' from CDRH, you may either send an email request to [email protected] to receive an electronic copy of...

77 FR 3002 - Certain Motion-Sensitive Sound Effects Devices and Image Display Devices and Components and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-20

... U.S. Patent Nos. 5,825,427 (``the '427 patent'') and 6,150,947 (``the '947 patent''). The Commission... investigation, namely the '427 patent and the '947 patent. The complaint in the 787 [[Page 3003

76 FR 54252 - In the Matter of Certain Wireless Devices With 3G Capabilities and Components Thereof; Notice of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-31

... With 3G Capabilities and Components Thereof; Notice of Institution of Investigation Institution of... States after importation of certain wireless devices with 3G capabilities and components thereof by... after [[Page 54253

76 FR 52734 - Underwater Locating Devices (Acoustic) (Self-Powered)

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-23

...This notice announces the planned revocation of all Technical Standard Order authorizations (TSOA) issued for the production of Underwater Locating Devices (Acoustic) (Self-Powered) manufactured to the TSO-C121 and TSO-C121a specifications. These actions are necessary because the planned issuance of TSO-C121b, Underwater Locating Devices (Acoustic) (Self-Powered), with a minimum performance standard (MPS) that will increase the minimum operating life of Underwater Locating Devices from 30 days to 90 days.

77 FR 13174 - Underwater Locating Devices (Acoustic) (Self-Powered)

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-05

...This is a confirmation notice for the planned revocation of all Technical Standard Order authorizations issued for the production of Underwater Locating Devices (Acoustic) (Self-Powered) manufactured to the TSO-C121 and TSO-C121a specifications. These actions are necessary because the planned issuance of TSO-C121b, Underwater Locating Devices (Acoustic) (Self-Powered), minimum performance standard (MPS) will increase the minimum operating life of Underwater Locating Devices from 30 days to 90 days.

Da Vinci robot error and failure rates: single institution experience on a single three-arm robot unit of more than 700 consecutive robot-assisted laparoscopic radical prostatectomies.

PubMed

Zorn, Kevin C; Gofrit, Ofer N; Orvieto, Marcelo A; Mikhail, Albert A; Galocy, R Matthew; Shalhav, Arieh L; Zagaja, Gregory P

2007-11-01

Previous reports have suggested that a 2% to 5% device failure rate (FR) be quoted when counseling patients about robot-assisted laparoscopic radical prostatectomy (RLRP). We sought to evaluate our FR on the da Vinci system. Since February 2003, more than 800 RLRPs have been performed at our institution using a single three-armed robotic unit. A prospective database was analyzed to determine the device FR and whether it resulted in case abortion or open conversion. Intuitive Surgical Systems provided data concerning the system's performance, including its fault rate. Error messages were classified as recoverable and non-recoverable faults. Between February 2003 and November 2006, 725 RLRP cases were available for evaluation. There were no intraoperative device failures that resulted in a case conversion. Technical errors resulting in surgeon handicap occurred in 3 cases (0.4%). Four patients (0.5%) had their procedures aborted secondary to system failure at initial set-up prior to patient entrance to the operating room. Data analysis retrieved from the da Vinci console reported on a total of 807 procedures since 2003. Only 4 cases (0.4%) were reported from the Intuitive Surgical database to result in either an aborted or a converted case, which compares favorably with our results. Since the last computer system upgrade (September 2005), the mean recoverable and non-recoverable fault rates per procedure were 0.21 and 0.05, respectively. For all the advanced features the da Vinci system offers, it is surprisingly reliable. Throughout our RLRP experience, device failure resulted in case conversion, procedure abortion, and surgeon handicap in 0, 0.5%, and 0.4% of procedures, respectively. As such, a lowered device FR of 0.5% should be used when counseling patients undergoing RLRP. To avoid futile general anesthesia, a policy should be enforced to ensure that the da Vinci system is completely set up before the patient enters the operating room.

77 FR 64546 - Certain Devices With Secure Communication Capabilities, Components Thereof, and Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-22

... Communication Capabilities, Components Thereof, and Products Containing Same; Institution of Investigation... VirnetX, Inc., of Zephyr Cove, Nevada and Science Applications International Corporation of McLean... sale within the United States after importation of certain devices with secure communication...

75 FR 20399 - Notice of Issuance of Regulatory Guide

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-19

..., Revision 1, ``Establishing Quality Assurance Programs for the Manufacture and Distribution of Sealed... Manufacture and Distribution of Sealed Sources and Devices Containing Byproduct Material,'' was issued with a... during the review of an application to manufacture or distribute sealed sources and devices containing...

76 FR 27061 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-05-10

...] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment... Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices AGENCY: Food and Drug... Systemic Antibacterial Drug Products and Antimicrobial Susceptibility Testing Devices--(OMB Control Number...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-14

... solicited to inform our Comparative Effectiveness Review of Intravascular Diagnostic Procedures and Imaging... scientific information on this device will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review...

76 FR 74789 - Scientific Information Request on Pressure Ulcer Treatment Medical Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-01

... Strategies: A Comparative Effectiveness Review, which is currently being conducted by the Evidence-based... scientific information on these devices will improve the quality of this comparative effectiveness review. AHRQ is requesting this scientific information and conducting this comparative effectiveness review...

77 FR 6028 - Taxable Medical Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-07

... use by the purchaser for further manufacture, or for resale by the purchaser to a second purchaser for use by such second purchaser in further manufacture, and (ii) for export, or for resale by the... manufacture, prepare, propagate, compound, assemble, process, repackage, or relabel medical devices intended...

75 FR 79049 - Final Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-17

... (RG) 5.80, ``Pressure-Sensitive and Tamper-Indicating Device Seals for Material Control and Accounting... and licenses. Regulatory Guide 5.80, ``Pressure-Sensitive and Tamper-Indicating Device Seals for... and Use of Pressure-Sensitive Seals on Containers for Onsite Storage of Special Nuclear Material...

76 FR 78931 - Advisory Committees; Tentative Schedule of Meetings for 2012

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-20

... FOR BIOLOGICS EVALUATION AND RESEARCH Allergenic Products Advisory Committee. April 18, October 18...- 15. CENTER FOR DRUG EVALUATION AND RESEARCH Anesthetic and Analgesic Drugs Advisory February 9...-6. Ophthalmic Devices Panel November 8-9. Orthopedic and Rehabilitation Devices September 13-14...

75 FR 43979 - Massachusetts Marine Sanitation Device Standard-Notice of Determination

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-27

... England Region, Office of Ecosystem Protection, Oceans and Coastal Protection Unit, Five Post Office... ENVIRONMENTAL PROTECTION AGENCY [EPA-R01-OW-2010-0318, FRL-9180-3] Massachusetts Marine Sanitation Device Standard--Notice of Determination AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of...

76 FR 39395 - Massachusetts Marine Sanitation Device Standard-Notice of Determination

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-06

... England Region, Office of Ecosystem Protection, Oceans and Coastal Protection Unit, Five Post Office... ENVIRONMENTAL PROTECTION AGENCY [EPA-R01-OW-2011-0364, FRL-9430-1] Massachusetts Marine Sanitation Device Standard--Notice of Determination AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of...

75 FR 38516 - Massachusetts Marine Sanitation Device Standard-Notice of Determination

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-02

... England Region, Office of Ecosystem Protection, Oceans and Coastal Protection Unit, Five Post Office... ENVIRONMENTAL PROTECTION AGENCY [EPA-R01-OW-2010-0316, FRL-9170-4] Massachusetts Marine Sanitation Device Standard--Notice of Determination AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of...

75 FR 4379 - Maine Marine Sanitation Device Standard-Notice of Determination

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-27

... Protection Agency--New England Region, Office of Ecosystem Protection, Coastal and Oceans Protection Unit... ENVIRONMENTAL PROTECTION AGENCY [EPA-R01-OW-2009-0304, FRL-9106-3] Maine Marine Sanitation Device Standard--Notice of Determination AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of...

78 FR 20665 - Pediatric Device Consortia Grant Program

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-05

... population (neonates, infants, children, and adolescents) includes patients who are 21 years of age or... of the Office of Orphan Products Development (OOPD) Pediatric Device Consortia (PDC) Grant Program. The goal of the PDC Grant Program is to facilitate the development, production, and distribution of...

78 FR 70320 - Certain Mobile Handset Devices and Related Touch Keyboard Software; Commission Determination Not...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-25

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-864] Certain Mobile Handset Devices and Related Touch Keyboard Software; Commission Determination Not To Review an Initial Determination Terminating the Investigation; Termination of the Investigation AGENCY: U.S. International Trade Commission...

48 CFR 252.225-7017 - Photovoltaic Devices.

Code of Federal Regulations, 2014 CFR

2014-10-01

... substantially transformed outside of a Caribbean Basin country. Designated country means— (i) A World Trade..., Spain, Sweden, Switzerland, Taiwan (known in the World Trade Organization as “the Separate Customs..., qualifying country, or designated country photovoltaic devices. (End of clause) [76 FR 78861, Dec. 20, 2011...

77 FR 59667 - NIJ Evaluation of Through-Wall Sensor Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2012-09-28

..., Surveillance, and Biometric Technologies Center of Excellence (SSBT CoE). The evaluation is focused on field operation in civilian law enforcement scenarios. Supplied through-wall sensor devices must be fully certified by the Federal Communications Commission for domestic civilian law enforcement operation...

75 FR 68972 - Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-10

... running to unintended areas, etc. Wound dehiscence Bench Testing, Shelf Life Testing, Animal Testing, Clinical Studies, Labeling. Adverse tissue reaction and chemical Biocompatibility Animal burns. Testing, Clinical Studies. Infection Bench Testing, Biocompatibility Animal Testing, Clinical Studies, Sterility...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-23

... recommendations, and vote on information regarding the premarket approval (PMA) application for the Nucleus[supreg... Nucleus[supreg] Hybrid TM L24 Implant System (as stated in the PMA) is as follows: The Nucleus[supreg...

77 FR 40735 - Unique Device Identification System

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-10

... Identification System AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. SUMMARY: The Food and... Regulatory Action This rule is intended to substantially reduce existing obstacles to the adequate... appropriate, better-focused, corrective action. The rule will also require dates on medical device labels to...

78 FR 24425 - Assay Migration Studies for In Vitro Diagnostic Devices; Guidance for Industry and Food and Drug...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-25

... approach to gain FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a... approach to gain FDA approval of Class III or certain licensed in vitro diagnostic devices in cases when a... fulfilled in order for a sponsor to utilize the migration study approach in support of the change. The FDA...

42 CFR 414.228 - Prosthetic and orthotic devices.

Code of Federal Regulations, 2014 CFR

2014-10-01

...) of this section. (c) Payment for therapeutic shoes. The payment rules specified in paragraphs (a) and (b) of this section are applicable to custom molded and extra depth shoes, modifications, and inserts (therapeutic shoes) furnished after December 31, 2004. [57 FR 57691, Dec. 7, 1992, as amended at 60 FR 35498...

76 FR 56294 - Inflatable Personal Flotation Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-13

... effective as scheduled. Instead, the Coast Guard plans to consider these issues in a notice of proposed rulemaking. DATES: The direct final rule published March 30, 2011, (76 FR 17561), is withdrawn effective... or copying at the Docket Management Facility (M-30), U.S. Department of Transportation, West Building...

76 FR 6826 - Certain Display Devices Including Digital Televisions and Monitors; Notice of Commission...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-08

... Commission instituted this investigation on April 21, 2010, based on a complaint filed by Sony Corporation of Japan (``Sony''). 75 FR 20860-1. The complaint, as amended and supplemented, alleges violations of... Corporation and Innolux Corporation (collectively ``CMI''); TPV Technology Limited; Top Victory Electronics...

21 CFR 862.1295 - Folic acid test system.

Code of Federal Regulations, 2013 CFR

2013-04-01

... treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow. (b) Classification. Class II. [52 FR 16122, May 1, 1987; 53 FR....1295 Folic acid test system. (a) Identification. A folic acid test system is a device intended to...

40 CFR 63.2986 - How do I comply with the standards?

Code of Federal Regulations, 2010 CFR

2010-07-01

... or other control device or implement a process modification that reduces formaldehyde emissions from... and maintain your affected source, including air pollution control and monitoring equipment, according... malfunctioning process and air pollution control equipment. [67 FR 17835, Apr. 11, 2002, as amended at 71 FR...

75 FR 61479 - Western Passage OCGenTM

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-05

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 12680-004] Western Passage...' express permission. The proposed project would consist of: (1) 2 OCGen\\TM\\ hydrokinetic tidal devices each... turbine-generating units of each device to a shore station; (5) a 2,800-foot-long, 34.5-kilovolt...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-16

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

76 FR 70164 - Certain Devices With Secure Communication Capabilities, Components Thereof, and Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-10

... capabilities, components thereof, and products containing the same. The complaint names Apple Inc. of Cupertino..., Components Thereof, and Products Containing the Same; Receipt of Complaint; Solicitation of Comments Relating... Certain Devices with Secure Communication Capabilities, Components Thereof, and Products Containing the...

78 FR 17086 - Public Hearing Before a Public Advisory Committee; Technical Amendments

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-20

... Administrative practice and procedure, Advisory committees, Color additives, Drugs, Foods, Medical Devices... device good manufacturing practice advisory committees established under section 520(f)(3) of the FD&C...) Color additive advisory committees are required to be established under the circumstances specified in...

75 FR 80059 - Advisory Committees; Tentative Schedule of Meetings for 2011

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-21

... BIOLOGICS EVALUATION AND RESEARCH Allergenic Products Advisory Committee. May 12. Blood Products Advisory... Advisory Committee. September 20-21, November 16- 17. CENTER FOR DRUG EVALUATION AND RESEARCH Anesthetic... Gynecology Devices Panel May 19-20, September 22-23. Ophthalmic Devices Panel February 18. Orthopedic and...

78 FR 32689 - Certain Portable Electronic Communications Devices, Including Mobile Phones and Components...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-31

..., Including Mobile Phones and Components Thereof Notice of Receipt of Complaint; Solicitation of Comments... Certain Portable Electronic Communications Devices, Including Mobile Phones and Components Thereof, DN... mobile phones and components thereof. The complaint names as respondents HTC Corporation of China and HTC...

78 FR 63492 - Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-24

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-847] Certain Electronic Devices, Including Mobile Phones and Tablet Computers, and Components Thereof; Notice of Request for Statements on the Public Interest AGENCY: U.S. International Trade Commission. ACTION: Notice. SUMMARY: Notice is...

76 FR 3145 - Pediatric Device Consortia Grant Program (P50)

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-19

... use in children. The program does not support the development of single device projects. Although... population (neonates, infants, children, and adolescents) includes patients who are 21 years of age or... adults. Children differ from adults in terms of their size, growth, development, and body chemistry...

75 FR 36678 - In the Matter of Certain Authentication Systems, Including Software and Handheld Electronic...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-28

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-697] In the Matter of Certain Authentication Systems, Including Software and Handheld Electronic Devices; Notice of Commission Decision Not to... importation of certain authentication systems, including software and handheld electronic devices, by reason...

78 FR 77166 - Certain Optoelectronic Devices for Fiber Optic Communications, Components Thereof, and Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-20

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-860] Certain Optoelectronic Devices for Fiber Optic Communications, Components Thereof, and Products Containing the Same; Notice of Request for Statements on the Public Interest AGENCY: U.S. International Trade Commission. ACTION: Notice. SUMMARY...

78 FR 2647 - Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-14

.... FDA-2012-N-0677] Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant AGENCY: Food...) is proposing to reclassify the blade- form endosseous dental implant, a preamendments class III... proposing to revise the classification of blade-form endosseous dental implants. DATES: Submit either...

75 FR 79028 - Proposed Extension of Existing Information Collection; Self-Contained Self-Rescue Devices (SCSRs)

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-17

... DEPARTMENT OF LABOR Mine Safety and Health Administration [OMB Control No. 1219-0044] Proposed Extension of Existing Information Collection; Self- Contained Self-Rescue Devices (SCSRs) AGENCY: Mine... be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-01

... use, existing scientific research data to determine pediatric effectiveness based on a similar course... research data, and C. The methods to overcome the pitfalls and data gaps, including statistical approaches... announcing a public workshop entitled ``Using Scientific Research Data to Support Pediatric Medical Device...

48 CFR 252.225-7017 - Photovoltaic Devices.

Code of Federal Regulations, 2013 CFR

2013-10-01

... substantially transformed outside of a Caribbean Basin country. Designated country means— (i) A World Trade..., Sweden, Switzerland, Taiwan (known in the World Trade Organization as “the Separate Customs Territory of..., qualifying country, or designated country photovoltaic devices. (End of clause) [76 FR 78861, Dec. 20, 2011...

76 FR 24051 - In the Matter of Certain Electronic Devices, Including Mobile Phones, Mobile Tablets, Portable...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-29

..., Including Mobile Phones, Mobile Tablets, Portable Music Players, and Computers, and Components Thereof... certain electronic devices, including mobile phones, mobile tablets, portable music players, and computers... mobile phones, mobile tablets, portable music players, and computers, and components thereof that...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-14

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

76 FR 11789 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-03

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0344...; Testing Communications on Medical Devices and Radiation-Emitting Products AGENCY: Food and Drug... collection of information entitled ``Testing Communications on Medical Devices and Radiation-Emitting...

78 FR 6834 - Certain Cases for Portable Electronic Devices; Institution of Investigation

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-31

... INTERNATIONAL TRADE COMMISSION [Investigation No. 337-TA-867] Certain Cases for Portable Electronic Devices; Institution of Investigation AGENCY: U.S. International Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on...

77 FR 19293 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-30

... as rheumatoid arthritis; c. Correction of functional deformity; and, d. Revision procedures where... the hip (DDH); or b. Inflammatory arthritis such as rheumatoid arthritis. Resurfacing systems are... degenerative joint disease (NIDJD) such as osteoarthritis, avascular necrosis, post-traumatic arthritis...

78 FR 47698 - Appraisal Subcommittee Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-06

... FEDERAL FINANCIAL INSTITUTIONS EXAMINATION COUNCIL [Docket No. AS13-18] Appraisal Subcommittee... the ASC requests that an item be moved to the discussion agenda.) Discussion Agenda: ASC 2014-18... reasonable basis. The use of any video or audio tape recording device, photographing device, or any other...