Thursday, November 24, 2011

FDA solicits feedback on an open web site re the Intsitute of Medicine report on the fast tracking of medical devices (501K process) for device approval


A spokesperson with the FDA told CBS 11 News that the FDA is now considering all feedback on the IOM’s (Institute of Medicine)  recommendation in an open forum on the FDA’s website. The medical device makers and associations in favor of keeping the 510K rule in place argue that the 510K rule is needed because patients should not have to wait the normal five-to-ten years to get a product approved that has subtle differences to those on the market.

The depuy hip went through this approval process which of course they later recalled voluntarily.

The FDA is expected to make some decision regarding the status of this three-decade old procedure next year.

CLICK HERE to read the FDA’s public comments and an open forum on the IOM report.  There are about 50 comments from many in the medical community including insurance companies and medical groups.    The FDA commissioned this report from the IOM to comment on the overall approval process for allowing medical devices to come to market.  The IOM report came out with 8 recommendations for changing the system of approval which it seems, most concur with.

The IOM finds that the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle. The IOM outlines its criteria for this framework in the report.

More information can be found on a prior post here:

Center for Devices and Radiological Health 510(k) Clearance Process; Institute of Medicine Report: “Medical Devices and the Public’s Health, The FDA 510(k) Clearance Process at 35 Years;” Request for Comments!docketDetail;rpp=10;po=0;D=FDA-2011-N-0556

No comments:

Post a Comment