Thursday, August 4, 2011

Reivew of the 501k clearance process at 35 years for medical devices

 
 
[This report discusses the issues surrounding the process used to approve devices such as the Depuy hip and other medical devices.  I believe most observers see this as a flawed process and many have recommended changes to this process.The Institute of Medicine said in a report released today that the FDA should instead require each device maker to prove the moderate-risk (or Class II) products are safe and effective, and possibly test the devices on actual patients. Last week, the Government Accountability office said that a staggering 83 percent of 700 devices recalled every year are Class II.]

Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years

Released:
July 29, 2011
Type:
Consensus Report
Topics:
Public Health, Quality and Patient Safety
Activity:
Public Health Effectiveness of the FDA 510(k) Clearance Process
Board:
Board on Population Health and Public Health Practice

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