Navigation Links
FDA should invest in developing a new regulatory framework to replace flawed 510(k) medical device clearance process
Date:7/29/2011

WASHINGTON The U.S. Food and Drug Administration should gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices, says a new report from the Institute of Medicine. The 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effectiveness of moderate-risk Class II devices and cannot be transformed into one, concluded the committee that wrote the report.

FDA's finite resources would be better invested in developing a new framework that uses both premarket clearance and improved postmarket surveillance of device performance to provide reasonable assurance of the safety and effectiveness of Class II devices throughout the duration of their use, the committee said. The agency should also ensure that the new process allows devices to reach the market in as rapid and least burdensome a fashion as possible.

As directed by congressional legislation, the 510(k) clearance process provides a more expedient way to evaluate moderate-risk Class II devices than the premarket approval (PMA) that high-risk Class III devices must undergo. Unlike the PMA process, which requires manufacturers to submit results of safety and efficacy tests, the 510(k) clearance generally relies on "substantial equivalence" -- determining if new devices are sufficiently similar to comparable products that have been previously cleared or were on the market prior to 1975 when the 510(k) process was first put in place by legislative action.

However, reliance on substantial equivalence cannot assure that devices reaching the market are safe and effective, the committee concluded. The majority of the devices used as the basis for comparison were never reviewed for safety or effectiveness. This does not mean that they or the devices that followed them are unsafe, and the continual use of many of these products in clinical practice provides a level of
'/>"/>

Contact: Christine Stencel
news@nas.edu
202-334-2138
National Academy of Sciences
Source:Eurekalert

Page: 1 2 3

Related medicine news :

1. Girl Softball Players Suffering More Shoulder Injuries
2. Anthem Blue Crosss Announcement That It Will Temporarily Suspend a 39% Health Insurance Rate Increase Should Not Deter Immediate Legislative Action
3. NIH Stem Cell Guidelines Should Be Modified, UCSF Team Reports
4. Rate Regulation for Health Insurance: Obama Administration Should Look to CAs Model Law Which Has Saved Drivers $62 Billion Since 1988
5. Virtually Everyone Should Get a Flu Shot: CDC
6. HIV drug that protects a fetus should be avoided for one year after childbirth, researchers say
7. California Dental Hygienists Say National Children's Dental Health Month Should Be a Yearlong Effort
8. Six "Common Sense" Points Not Included In The Health Care Discussion? Should They Be?
9. Six "Common Sense" Points Not Included In The Health Care Discussion? Should They Be?
10. Young Men and Elderly Women at Biggest Risk for Shoulder Dislocations
11. Shoulder Dislocations a Sports Hazard
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/1/2015)... ... September 01, 2015 , ... WorkCare, Inc., a national ... medical management team as an Associate Medical Director. , WorkCare specializes in ... the U.S. and abroad. , Dr. Nelson has a diverse background. He ...
(Date:9/1/2015)... ... 01, 2015 , ... SC&H Group, a leading audit, tax, and consulting firm, ... of the Best” firm in the U.S., as well as being ranked a Top ... in the U.S., selected exclusively on performance in specific areas of financial and operational ...
(Date:9/1/2015)... (PRWEB) , ... September 01, 2015 , ... Mercy Health ... has devoted the 10th of its monthly Mercy Health: Helping You Be Well videos ... one in seven men. , In a concise video on Mercy Health’s YouTube ...
(Date:9/1/2015)... FL (PRWEB) , ... September 01, 2015 , ... ... discount cards, launched its consumer-friendly, informational video this week to coincide with back-to-school ... http://www.USAMedicalCard.com/video . , According to the CDC, elementary school children are sick ...
(Date:9/1/2015)... OHIO (PRWEB) , ... September 01, 2015 , ... Dr. ... today at JourneyLite of Cincinnati. In the last month the FDA has approved ... ReShape Duo ™. These procedures represent the first incisionless, reversible, weight loss procedures ...
Breaking Medicine News(10 mins):Health News:Dr. Brent Nelson Joins WorkCare, Inc., as Associate Medical Director 2Health News:Dr. Brent Nelson Joins WorkCare, Inc., as Associate Medical Director 3Health News:SC&H Group Receives Multiple Honors from INSIDE Public Accounting 2Health News:New Mercy Health Video Explains Most-Common Cancer Found in Men 2Health News:USA Medical Card Launches New FAQ Video During Back-to-School 2Health News:Dr. Trace Curry Performs First ORBERA™ Intra-gastric Balloon in Ohio at JourneyLite, a New Incisionless Option For The Treatment of Obesity 2
... the skin unleashes a complex cascade of chemistry to stem ... of Medicine in St. Louis have used evolutionary clues to ... new light on common bleeding disorders. The long tube-shaped ... von Willebrand Factor (VWF). Made in cells that form the ...
... to improve global health, alleviate hunger, raise living standards ... an important role to play. Jagdev ... and Vaccinology at Arizona State University,s Biodesign Institute has ... of chicken for villagers in rural Uganda. He reports ...
... WEDNESDAY, July 20 (HealthDay News) -- The number of surgical ... new study finds. In reviewing adverse events and close ... report in the July 15 issue of the Archives ... a greater emphasis on safety, as well as improved training ...
... in the Breast Health Center at Women & Infants ... to earn a 2011 Breast Cancer Symposium Merit Award ... of Clinical Oncology (ASCO). The award, which recognizes ... to Shannon MacLaughlan, MD, who is also affiliated with ...
... that is affected during the onset of schizophrenia and successfully ... drug currently in advanced clinical trials., The research, published ... group led by Professor Peter Giese at King,s College London, ... Schizophrenia is one of the most common serious mental health ...
... of thousands of people, injuring a muscle through an accident ... in a strange and serious complication. Their muscles start growing ... abnormal bone growth, so there was no treatment. But now, ... Perelman School of Medicine at the University of Pennsylvania shows ...
Cached Medicine News:Health News:Evolution provides clue to blood clotting 2Health News:Evolution provides clue to blood clotting 3Health News:A new breed: Highly productive chickens help raise Ugandans from poverty 2Health News:A new breed: Highly productive chickens help raise Ugandans from poverty 3Health News:Fewer Surgical Errors Reported at VA Medical Facilities 2Health News:Cancer drugs may help treatment of schizophrenia 2Health News:When injured muscles mistakenly grow bones 2
(Date:9/1/2015)... Sept. 1, 2015 Sargas Pharmaceutical Adherence ... and Drug Adherence m Health applications along with ... process of non face-to-face monitoring of twenty minutes ... release of our apps, doctors are now well ... with our ONCHIT certified Physician, Pharmacy and Patient ...
(Date:9/1/2015)... Within just two years after reaching a ... reached 3,000 employees worldwide. This increase is reflecting ... drug delivery market and SHL,s effective commitment, productivity ... the design and manufacturing of auto injectors and ... capabilities, a lean supply chain, strong partnerships, and ...
(Date:9/1/2015)... 2015 Egalet Corporation (Nasdaq: EGLT ... focused on discovering, developing, and commercializing innovative pain ... scientific data on SPRIX ® (ketorolac tromethamine) ... product candidate, and Egalet-002, an abuse-deterrent, extended-release, oral ... 2015 to be held September 8 to 12 ...
Breaking Medicine Technology:SPAC International's Drug Adherence and Chronic Care Management App Now available at Apple App and Google Play stores 2SHL Group Reaches Major Milestone of 3000 Employees 2Egalet Announces Scientific Presentations at PainWeek 2015 Meeting 2Egalet Announces Scientific Presentations at PainWeek 2015 Meeting 3Egalet Announces Scientific Presentations at PainWeek 2015 Meeting 4Egalet Announces Scientific Presentations at PainWeek 2015 Meeting 5Egalet Announces Scientific Presentations at PainWeek 2015 Meeting 6
... Inc., a privately-held therapeutic device company, today announced ... with Bezwada Biomedical to develop and commercialize Bezwada,s ... Biomedical is an innovation-driven company with proprietary technology ... polyamides derived from hydrolyzable isocyanates. This technology can ...
... Aug. 31, 2011 Assured Pharmacy, Inc. (Pink Sheets: ... that provide advanced prescription services to a diverse array ... it sold in a private placement to an accredited ... an aggregate principal amount of $400,000 due December 1, ...
Cached Medicine Technology:ORTHOCON Announces Signing of Exclusive, Worldwide License Agreement With Bezwada Biomedical 2Assured Pharmacy, Inc. Receives Gross Proceeds of $400,000 from Sale of Convertible Debentures and Warrants 2Assured Pharmacy, Inc. Receives Gross Proceeds of $400,000 from Sale of Convertible Debentures and Warrants 3
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: