The FDA says it is currently working on a national surveillance strategy.
Government Accountability Office Report on Shortcomings in the FDA's Medical Device Review and Surveillance Process
Subscription Center
A substantial number of risky devices are cleared for medical use without clinical testing, including some hip implants, surgical mesh, heart valve rings and defibrillator leads
The FDA says it is currently working on a national surveillance strategy.
Government Accountability Office Report on Shortcomings in the FDA's Medical Device Review and Surveillance Process
See what we're tweeting about
Deadline: Jun 29 2013
Reward: $7,000 USD
The Seeker for this Challenge desires proposals for chemical methods that could rapidly degrade a dilute aqueous solution
Deadline: Aug 31 2013
Reward: $100,000 USD
The Geoffrey Beene Foundation Alzheimer’s Initiative (GBFAI) is launching the 2013 Geoffrey Beene Global NeuroDiscovery Challenge whose
Powered By: 
YES! Send me a free issue of Scientific American with no obligation to continue the subscription. If I like it, I will be billed for the one-year subscription.
4 Comments
Add CommentThe 510(k) was originally meant for low risk devices. Now manufacturers are exploiting this loophole in order to dodge proper safety practices at the cost of consumer safety:
Reply | Report Abuse | Link to thishttp://www.newsinferno.com/defective-medical-devices/metal-on-metal-hip-implants-endangering-thousands-thanks-to-lax-regulation-in-u-s-and-abroad/35936
The 510(k) was originally meant for low risk devices. Now manufacturers are exploiting this loophole in order to dodge proper safety practices at the cost of consumer safety:
Reply | Report Abuse | Link to this<a href="http://www.newsinferno.com/defective-medical-devices/metal-on-metal-hip-implants-endangering-thousands-thanks-to-lax-regulation-in-u-s-and-abroad/35936">Metal-on-Metal Hip Implants Endangering Thousands, Thanks to Lax Regulation in U.S. and Abroad </a>
Is this a case of FDA bad practices or simply having to be more "efficient" because there isn't the funding or manpower to conduct the longer, more thorough review processes?
Reply | Report Abuse | Link to thisOnly four - are you kidding, where have you been hiding?
Reply | Report Abuse | Link to thisAccording to an article entitled; Medical device recalls and the FDA approval process by Diana M. Zuckerman et.al, and published in Arch Intern Med.2011Jun13;17(11):1006-11
There were 113 recalls from 2005 through 2009 that the FDA determined could cause serious health problems or death.
Only 21 of the 113 devices had been approved through the PMA process (19%).
Eighty were cleared through the 510(k) process (71%),
and an additional 8 were exempt from any FDA regulation (7%).
Cardiovascular devices comprised the largest recall category, with 35 of the high-risk recalls (31%); two-thirds were cleared by the 510(k) process (66%; n=23).
Fifty one percent of the high-risk recalls were in 5 other device categories: general hospital,anesthesiology, clinical chemistry, neurology, or ophthalmology.
In addition to the 113 recalls – you may remember even older recalls:
Dalkon Shield IUD made by A.H. Robins
Proplat-Teflon Jaw Implant by Vitek, Inc. for (TMJ)
Ivalon (polyvinyl) sponge breast implants
Polyurethane coated breast implants
Trilucent (soya bean oil) breast implants