Navigation Links
FDA Issues Assessments of the 510(k) Program and Use of Science in Decision-Making
Date:8/4/2010

"Even with our significant outreach, it's important to remember that these recommendations are preliminary," said Shuren. "CDRH opened another public docket to receive additional comments on both reports. We will make a decision on which recommendations to adopt only after a thorough review of additional comments."

Selected recommendations and the key public health objectives they address include:

Fostering Device Innovation

  • The 510(k) report recommends major improvements to the regulatory pathway for lower-risk novel devices that cannot be cleared through 510(k) but which do not warrant the more rigorous premarket approval review applied to higher-risk devices. The report calls for major reforms in the implementation of this process – called the de novo classification process. The recommendations include streamlining the process and clarification of CDRH's expectations for submissions that undergo this type of review.
  • The science report recommends that CDRH make better use of scientific experts outside of the agency by developing a web-based network of external experts using social media technology. This network would help CDRH staff leverage outside knowledge without serving in an advisory capacity.

Enhancing Regulatory Predictability

  • The 510(k) report recommends that CDRH develop a guidance document defining a subset of moderate-risk (Class II) devices, called Class IIb, for which clinical or manufacturing data typically would be necessary to support a substantial equivalence determination. This guidance document would help clarify what information submitters should include in their 510(k) submissions so that they can plan accordingly. In addition, this would also help
    '/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. China Sky One Medicals Chief Financial Officers Health Issues to Restrict His Availability to Investors
2. ECRI Institute Reissues Cost-Saving Tips to Help Hospitals Make Capital Technology Purchases With Scarce Resources
3. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Issues Practice Guideline Addressing the Management of Gastroesophageal Reflux Disease and Barretts Esophagus
4. FDA Issues Statement on Baxters Recall of Colleague Infusion Pumps
5. ECRI Institute(R) Issues Expanded Recommendations for Controlling CT Radiation Dose: Computed Tomography Dose is on the Institutes 2010 List of Top 10 Technology Hazards
6. Viral Genetics CEO Issues State of the Company Update
7. FDA Issues Complete Response Letter for Low Dose Oral Contraceptive
8. Terumo to Sponsor Presentations on Key Issues in Cardiac and Vascular Surgery at Society of Thoracic Surgeons Annual Meeting
9. FDA Issues Complete Response Letter for Ceftobiprole
10. ECRI Institute Issues Steris System 1 High Priority Alert and Recommendations: Free Guidance to Help Hospitals Map out Transition to Alternative Reprocessing Methods
11. U.S. Patent Office Issues Sword Diagnostics Patent for Highly Sensitive Immunodetection Technology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)...  Breg, Inc., a premier provider of sports ... knee brace with new innovations to help people, ... to active lifestyles.  FreeRunner,s patent-pending design acts on ... when patients need it most, and the ability ... Patellofemoral issues are the most common cause of ...
(Date:7/10/2014)... 2014  RESMED INC. (NYSE: RMD ) today ... year ended June 30, 2014 results on Thursday, July 31, ... press release with ResMed,s results will be issued after 1:00 ... webcast to discuss operating results and future outlook. ... US Pacific Time and the live webcast of the call ...
(Date:7/10/2014)... July 10, 2014  BC Technical, the largest nationwide, ... America , Inc., a leading provider of Siemens Nuclear ... long-term agreement naming BC Technical as the authorized provider ... MiE and BC Technical announced today that the ... BC Technical as the service and systems provider for ...
Breaking Medicine Technology:Breg Introduces Knee Brace to Help Runners with Patellofemoral Pain Syndrome 2ResMed To Announce Fourth Quarter And Fiscal Year-End 2014 Results 2BC Technical Partners With MiE America To Be Authorized Provider Of Systems & Service 2
... 2011 Symmetry Medical Inc. (NYSE: ... medical device solutions, including orthopedic implants, surgical instruments, ... it has signed a definitive agreement to acquire ... design, development and manufacturing of electrosurgical instruments and ...
... Aug. 3, 2011 Thoratec Corporation (NASDAQ: ... support therapies to save, support and restore failing hearts, ... were $111.2 million, a 17 percent increase over revenues ... Results for all periods of fiscal 2010 ...
Cached Medicine Technology:Symmetry Medical to Acquire Olsen Medical 2Symmetry Medical to Acquire Olsen Medical 3Thoratec Reports Second Quarter Revenue Increase of 17 Percent 2Thoratec Reports Second Quarter Revenue Increase of 17 Percent 3Thoratec Reports Second Quarter Revenue Increase of 17 Percent 4Thoratec Reports Second Quarter Revenue Increase of 17 Percent 5Thoratec Reports Second Quarter Revenue Increase of 17 Percent 6Thoratec Reports Second Quarter Revenue Increase of 17 Percent 7Thoratec Reports Second Quarter Revenue Increase of 17 Percent 8Thoratec Reports Second Quarter Revenue Increase of 17 Percent 9Thoratec Reports Second Quarter Revenue Increase of 17 Percent 10Thoratec Reports Second Quarter Revenue Increase of 17 Percent 11Thoratec Reports Second Quarter Revenue Increase of 17 Percent 12Thoratec Reports Second Quarter Revenue Increase of 17 Percent 13Thoratec Reports Second Quarter Revenue Increase of 17 Percent 14Thoratec Reports Second Quarter Revenue Increase of 17 Percent 15Thoratec Reports Second Quarter Revenue Increase of 17 Percent 16Thoratec Reports Second Quarter Revenue Increase of 17 Percent 17Thoratec Reports Second Quarter Revenue Increase of 17 Percent 18Thoratec Reports Second Quarter Revenue Increase of 17 Percent 19
(Date:7/13/2014)... 13, 2014 The report “Micronutrient ... Iron), Form (Chelated & Non Chelated), Application Mode ... Global Trends and Forecast to 2018” defines and ... analysis and forecasting of the global value and ... driving and restraining factors for the global agriculture ...
(Date:7/13/2014)... July 13, 2014 MarketsandMarkets recently ... [3D Modeling; 3D Scanning; 3D rendering; Layout and ... Analysis (2013 - 2018)”, which analyzes and studies ... North America, Western Europe, Eastern Europe, Middle East ... also draws the competitive landscape of the 3D ...
(Date:7/13/2014)... Athletes with a certain genetic make-up are prone ... research presented today at the American Orthopaedic Society for ... marks the first of its kind investigating a genetic ... that occur after a head injury. , “We ... (GT)n genotype were four times more likely to have ...
(Date:7/13/2014)... Recently, MyDressCity.com, one of the most popular ... has released its new range of elegant Quinceanera ... available at discounted prices. Worldwide clients can enjoy this ... the company’s online shop, there are plenty of beautiful ... with great materials. MyDressCity.com’s hot items are prom gowns, ...
(Date:7/13/2014)... 13, 2014 A decreased ability to identify ... and Alzheimer,s disease, while examinations of the eye ... associated with Alzheimer,s, in the brain, according to ... at the Alzheimer,s Association International Conference 2014 (AAIC ... studies, the decreased ability to identify odors was ...
Breaking Medicine News(10 mins):Health News:Micronutrient Market Worth $6,474.6 Million by 2018 - A Report by MarketsandMarkets 2Health News:Micronutrient Market Worth $6,474.6 Million by 2018 - A Report by MarketsandMarkets 3Health News:Micronutrient Market Worth $6,474.6 Million by 2018 - A Report by MarketsandMarkets 4Health News:3D Imaging Market Worth $9.82 Billion By 2018 - Report by MarketsandMarkets 2Health News:3D Imaging Market Worth $9.82 Billion By 2018 - Report by MarketsandMarkets 3Health News:3D Imaging Market Worth $9.82 Billion By 2018 - Report by MarketsandMarkets 4Health News:Genetic Factors May Be Responsible for Slowing Concussion Recovery in Athletes 2Health News:Cheap Elegant Quinceanera Dresses Unveiled by MyDressCity.com 2Health News:Smell and eye tests show potential to detect Alzheimer's early 2Health News:Smell and eye tests show potential to detect Alzheimer's early 3Health News:Smell and eye tests show potential to detect Alzheimer's early 4Health News:Smell and eye tests show potential to detect Alzheimer's early 5Health News:Smell and eye tests show potential to detect Alzheimer's early 6Health News:Smell and eye tests show potential to detect Alzheimer's early 7
... biomaterial, developed at the New Jersey Center for Biomaterials ... bench to field testing in record time. This achievement, ... is the enabling technology behind a coronary stent undergoing ... , Stents are tiny tubes inserted into diseased arteries ...
... of neurotransmitter dopamine , , THURSDAY, Oct. 18 (HealthDay ... the brain that may explain why some people ... difficult situations. , While the research was done ... better treatments for chronic stress, depression and the ...
... Minn. -- Mayo Clinic has clarified the methods of ... blood vessel disease of the brain and spinal cord ... nervous system vasculitis (PCNSV) can best be identified through ... the cerebral arteries), brain biopsy and other laboratory studies. ...
... Oct. 18 The U.S. House,Judiciary Committee Antitrust ... 971,the Community Pharmacy Fairness Act of 2007. The ... that would allow independent pharmacies to,compete fairly and ... (PBMs). In response Bruce Roberts, RPh, National Community,Pharmacists ...
... ReBuilder,Medical Technologies, Inc. (Pink Sheets: RBRM), an ... device inventor David B.,Phillips, Ph.D., today announced ... facilitation. (Logo: http://www.newscom.com/cgi-bin/prnh/20061128/REBUILDERLOGO ) ... are outsourcing customer service to,overseas facilities, the ...
... Preventive Medical Exams; New Women,s Health ... Texas, Oct. 18 Signaling the next phase ... residential,community under development in McKinney, the Cooper Clinic ... "Father of aerobics" Dr. Kenneth Cooper, who,founded Cooper ...
Cached Medicine News:Health News:Rutgers biomaterial debuts in clinical trials of new stent 2Health News:Rutgers biomaterial debuts in clinical trials of new stent 3Health News:Vulnerability to Stress Linked to Brain Molecule 2Health News:Vulnerability to Stress Linked to Brain Molecule 3Health News:Mayo Clinic clarifies diagnosis for serious blood vessel disease of brain and spinal cord 2Health News:Mayo Clinic clarifies diagnosis for serious blood vessel disease of brain and spinal cord 3Health News:ReBuilder Medical Technologies, Inc. Hires Nurses Exclusively to Provide Customer Support 2Health News:ReBuilder Medical Technologies, Inc. Hires Nurses Exclusively to Provide Customer Support 3Health News:Cooper Clinic at Craig Ranch Opens Signaling the Next Phase of CooperLife Health-Focused Residential Community in McKinney 2Health News:Cooper Clinic at Craig Ranch Opens Signaling the Next Phase of CooperLife Health-Focused Residential Community in McKinney 3
... Neuroprene™ soft supports are a ... to proprioceptive taping for common orthopedic ... help provide specific compression and lateral ... receptors (proprioceptors) in the skin and ...
... low-profile, wraparound, hinged knee product with an ... who have difficulty applying a sleeve, the ... ease of application. These pull points ... secure the anterior closure of the garment. ...
... innovative, new padding system from Innovation Sports. ... and contours to the unique anatomy of ... Plus, Gel Fit's proprietary Octogrip™ Anti-Slip System ... seal when the brace is strapped on. ...
... the world's most versatile functional knee brace. ... or both, Flex is equipped for the ... control flexion and extension and its carbon ... heat-moldable to accommodate changes in leg shape ...
Medicine Products: