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:8/28/2015)... LONDON , August 28, 2015 ... seamlessly connects people, technologies and care protoc ... improving outcomes and the cost of healthcare delivery   ... today announced its presence at  ESC Congress 2015 , where the ... A.I. , EchoNavigator and IntelliSpace Cardiovascular, that connect people and ...
(Date:8/27/2015)...  A recent study by Feucht et al, ... Arthrosurface HemiCAP® Wave implant, which is based on ... implant for isolated patellofemoral disease. While both implant ... scores, none of the patients in the "inlay" ... of the patients in the "onlay" group, showed ...
(Date:8/27/2015)... , Aug. 27, 2015 ieCrowd™ ... in the commercial development of the company,s supplemental ... Smart Oxygen device, being developed by ieCrowd,s subsidiary ... a patient,s changing demand for oxygen based on ... 510 (k) submission for the Smart Oxygen device ...
Breaking Medicine Technology:Philips Showcases New Integrated Cardiology Solutions to Advance Minimally Invasive Procedures at ESC Congress 2015 2Philips Showcases New Integrated Cardiology Solutions to Advance Minimally Invasive Procedures at ESC Congress 2015 3Philips Showcases New Integrated Cardiology Solutions to Advance Minimally Invasive Procedures at ESC Congress 2015 4Study Demonstrates Dramatic Reduction in Progression of Osteoarthritis with the Arthrosurface "Inlay" Patellofemoral Implant Design Compared to Traditional "Onlay" Implant 2Study Demonstrates Dramatic Reduction in Progression of Osteoarthritis with the Arthrosurface "Inlay" Patellofemoral Implant Design Compared to Traditional "Onlay" Implant 3Smart Oxygen Solutions' Supplemental Oxygen Delivery Device Achieves FDA Regulatory Pathway Milestone 2Smart Oxygen Solutions' Supplemental Oxygen Delivery Device Achieves FDA Regulatory Pathway Milestone 3Smart Oxygen Solutions' Supplemental Oxygen Delivery Device Achieves FDA Regulatory Pathway Milestone 4
... the global leader in technology support and BPO services ... today the opening of its new Global Operations Center ... city of Dalian, will specialize in providing services in ... sponsors and clinical research organizations. With dramatic ...
... ARBOR, Mich., April 7, 2011 Adeona Pharmaceuticals, Inc. (AMEX: ... serious central nervous system diseases, announced today that it has ... its common stock at approximately $2.0725 per share to a ... million in gross proceeds. The investor will also receive warrants ...
Cached Medicine Technology:C3i Opens Asia Language Center in Dalian, China 2Adeona to Raise $3.5 Million in Registered Direct Offering 2Adeona to Raise $3.5 Million in Registered Direct Offering 3
(Date:8/29/2015)... ... August 29, 2015 , ... Vascular ... market and sell Arterosil and Arterosil HP, and that all claims and counterclaims ... Vascular Health Sciences, LLC (VHS) in the United States District Court for the ...
(Date:8/28/2015)... ... 2015 , ... The Kentucky State Department of Workforce Investment Commissioner Beth Kuhn ... applying for, they are unable to pass the initial drug test and therefore unable ... in order to be able to hire long-term, skilled talent. (1) Will Wesch, Director ...
(Date:8/28/2015)... ... , ... As reported by Medical Daily on August 22 , Cellfina, ... last for two years, the longest of any cellulite reduction system currently on the ... long-lasting, effective solution for their cellulite, according to Dr. Robert Weiss, director of the ...
(Date:8/28/2015)... ... , ... “ Frequentz ” was featured on NewsWatch as part of its ... market for iOS, Android, and Windows. Joe Toohey, the host of AppWatch and technology ... to track product movement from beginning to end. , Businesses benefit greatly from having ...
(Date:8/28/2015)... , ... August 28, 2015 , ... ... three-year accreditation for its adolescent residential, counseling, day treatment and intensive family based ... meets international standards for quality and its pursuit of excellence. As a nonprofit ...
Breaking Medicine News(10 mins):Health News:Hiring Obstacles: Drug Abuse a Problem for Workforce 2Health News:Hiring Obstacles: Drug Abuse a Problem for Workforce 3Health News:Hiring Obstacles: Drug Abuse a Problem for Workforce 4Health News:Maryland Dermatologists Discuss Non-Invasive Cellulite Reduction System Cellfina Receiving 2-Year FDA Clearance 2Health News:Maryland Dermatologists Discuss Non-Invasive Cellulite Reduction System Cellfina Receiving 2-Year FDA Clearance 3Health News:Track Product Movement from Beginning to End with Frequentz 2Health News:West Ridge Academy Awarded CARF Three-Year Accrediation 2
... diet/nutrition as leading issue; exercise, physical changes, ... drug use also rank ... report from,the C.S. Mott Children,s Hospital National Poll on Children,s Health ... with kids ages 11 to 17 during routine check-ups. The topics ...
... Davis Collaboration, RANCHO CORDOVA, Calif., Feb. 6 ... supplier of innovative products and,services that process and ... injury, today announced a regenerative medicine initiative in ... wholly-owned subsidiary, Vantus, Inc., a,veterinary stem cell laboratory ...
... first step toward personalized medicine, experts say , , WEDNESDAY, Feb. ... blood test could help a small minority of HIV patients ... can sometimes cause serious side effects. , The test detects ... a patient,s genetic makeup is linked to poor reactions to ...
... multiple risk factors at once, , , WEDNESDAY, Feb. 6 (HealthDay ... showing signs of some kidney damage may be able to ... factors at once. , That,s the conclusion of a ... the New England Journal of Medicine , that found ...
... Burnham Institute for Medical Research (Burnham Institute) have provided ... a suppressor role in skin cancer development. ATF2 ... the first step in the translation of genetic code, ... and ionizing radiation. This function of ATF2 in ...
... has announced the names of the recipients of its annual ... Inder Verma is the prize recipient for biomedical science; the ... The Vilcek Foundation Prizes are awarded annually to foreign-born individuals ... , In explaining the motivation for the awards, Dr. ...
Cached Medicine News:Health News:Parents Identify Health Topics They Want Doctors to Discuss with Kids - New Research for University of Michigan Conducted by Knowledge Networks 2Health News:Thermogenesis Announces New Initiative to Address Veterinary Regenerative Medicine 2Health News:Thermogenesis Announces New Initiative to Address Veterinary Regenerative Medicine 3Health News:Thermogenesis Announces New Initiative to Address Veterinary Regenerative Medicine 4Health News:Test Detects Sensitivity to HIV Drug 2Health News:Aggressive Diabetes Therapy Lowers Death Risk, Study Finds 2Health News:Aggressive Diabetes Therapy Lowers Death Risk, Study Finds 3Health News:Gene found to play a suppressor role in skin cancer development 2Health News:Dr. Inder Verma named recipient of 2008 Vilcek Prize in biomedical science 2
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: