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

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

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