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

0

GOOD

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:5/20/2013)... when the spotlight is focused on obesity more than ever, ... associated with weight or certain adverse health risks. According to ... of Nutrition Journal , adults who consume candy at ... overweight nor have greater risk factors for cardiovascular disease (CVD) ... frequent candy eaters (less than 3 times per month).1 ...
(Date:5/20/2013)... Brenda Goodman HealthDay Reporter , , SATURDAY, May ... doctors a better view during colonoscopies may help them ... study shows. Colonoscopies are the recommended screening tests ... killer of men and women in the United States. ... flexible tube with a camera mounted on the end ...
(Date:5/20/2013)... HealthDay Reporter , , SUNDAY, May 19 (HealthDay News) -- ... sleep by endlessly and subconsciously waking them up, becomes ... study raises the possibility that it may somehow cause ... Don,t worry just yet if you have sleep ... there may be no connection between the two conditions. ...
(Date:5/20/2013)... News) -- If you,ve got bunions, chances are others ... with a new study finding the condition is often ... the May issue of Arthritis Care & Research ... inherit conditions such as bunions or other toe deformities. ... heritability of common foot disorders in older adults," Dr. ...
(Date:5/20/2013)... 20, 2013) Research presented at Digestive Disease Week ... with diarrhea (IBS-D) and hepatitis C. , An ... IBS-D. In the phase II study, researchers found that ... 50 percent of the individuals treated. , "While ... IBS with constipation, we haven,t seen the same in ...
Breaking Medicine News(10 mins):Health News:New study suggests candy consumption frequency not linked to obesity or heart disease 2Health News:New study suggests candy consumption frequency not linked to obesity or heart disease 3Health News:New Device May Show Doctors More of the Colon 2Health News:New Device May Show Doctors More of the Colon 3Health News:Sleep Apnea in Seniors Tied to Alzheimer's in Study 2Health News:Sleep Apnea in Seniors Tied to Alzheimer's in Study 3Health News:Many Can Blame Family for Their Bunions 2Health News:Pharmaceutical advances offer new options for health outcomes 2
... Identifying those at risk for diabetes is important because lifestyle ... the disease. Currently an oral glucose tolerance test is used ... costly and inconvenient. A new study finds a cluster of ... type 2 diabetes independently of other risk factors. ...
... the births of their first two children are more likely to ... have the same partner.// These babies are ... The results are the same even when researchers take into account ... decades of birth. ,Researchers speculate that women who ...
... Commonwealth's restaurants, taverns, and nightclubs, and voted to lift ... House and Senate concluded the year's business with a ... approved a sales tax "holiday" designed to spur shoppers ... economy, and approved $102 million in extra spending for ...
... new study shows a new drug alternative to warfarin in ... The research shows the drug ximelagatran appears to be as ... for people at high risk of stroke because of its ... include an increased risk of bleeding and a possible interaction ...
... promising therapy option may be more effective in treating the ... disease that causes persistent redness on the nose and cheeks. ... to the faces of rosacea sufferers. //The new product contains ... Typically it has a different formula and is used to ...
... is so easily cured that Luvie Owens almost forgot she ... her cause for concern: Women who have had the most ... to also get deadlier cancers such as breast, lung and ... is 7.5 times higher. ,The study didn't include men, ...
Cached Medicine News:Health News:Predictors for Type 2 Diabetes 2Health News:Changing Partners may put Expectant Mothers at Risk 2Health News:Senate assures ban on smoking 2Health News:Senate assures ban on smoking 3Health News:Senate assures ban on smoking 4Health News:People with skin cancer at higher risk for other types , 2
(Date:5/17/2013)... -- Lakeland Industries, Inc. (NASDAQ: LAKE ), a ... and to first responders on the federal, state and ... fiscal 2013 fourth quarter and year ended January 31, ... close and will conduct a conference call on the ... http://photos.prnewswire.com/prnh/20120611/NY21959LOGO ) The call will ...
(Date:5/17/2013)... May 17, 2013   Shareholder rights attorneys  at ... Pharmaceutical, Inc. (NASDAQGS: AVEO) securities has filed a complaint ... Massachusetts .  The complaint alleges that ... Exchange Act of 1934 (the "Exchange Act") between January ... (Logo: http://photos.prnewswire.com/prnh/20130103/MM36754LOGO ) ...
(Date:5/17/2013)... May 17, 2013 Research ... and outcomes research also   to   be presented ... SHPG ), the global specialty biopharmaceutical company, announces ... presentations at the American Psychiatric Association (APA) 166th Annual ... 18-22. The data being presented represent Shire,s ongoing commitment ...
Breaking Medicine Technology:Lakeland Industries to Report Fiscal Fourth Quarter and Year End Financial Results and Conduct Conference Call 2Aveo Pharmaceuticals, Inc. Sued by Investor 2Aveo Pharmaceuticals, Inc. Sued by Investor 3Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 2Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 3Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 4Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 5Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 6Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 7Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 8Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 9Shire to Present Scientific Data Across a Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting 10
... ANF Group, Inc ., a South Florida based ... 170,000-square-foot Joe DiMaggio Children,s Hospital – the first free ... (Photo: http://photos.prnewswire.com/prnh/20110614/FL18288 ) The hospital,s ... designed to earn Gold Leadership in Energy and Environment ...
... June 14, 2011 CVS/pharmacy provides ... at more than 7,200 convenient locations nationwide. Shoppers have come ... larger-than-ever selection of gifts, goods and everyday needs. From popular ... the hottest gear and thoughtful keepsakes perfect for every dad, ...
Cached Medicine Technology:ANF Group, Inc. Completes New Joe DiMaggio Children's Hospital 2Find the Best in Gadgets, Grilling and Grooming in Just One Stop This Father's Day at CVS/pharmacy 2Find the Best in Gadgets, Grilling and Grooming in Just One Stop This Father's Day at CVS/pharmacy 3
... workmanship are the hallmark of these stereozoom ... mind. The top (incident) circular 9W fluorescent ... while remaining cool to the touch. Binocular ... 10x to 44x zoom magnification or high-power ...
... IR/DIC video camera. Olympus wide array of high-quality ... quality and flexibility you need for an efficient ... real-time image of your specimen that can be ... You can even record movies when these easy-to-operate ...
... is a premium photomicrography system that ... even the most difficult specimens. Designed with ... system provide solution to the complex problem ... automatic exposure control, the system utilizes special ...
... systems for optimum image quality at low ... color digital camera system is specifically designed ... available. State-of-the-art electronics create bright, vibrant images ... dynamic range offered by the Leica cameras ...
Medicine Products: