The IOM report on the FDA’s 510(k) process

August 11, 2011

The IOM recently published the results of their FDA-commissioned report assessing whether the 510(k) process for approving medical devices was salvageable. The committee concluded that it should be scrapped and the FDA disagreed. This all made the front pages of the New York Times, etc.

We spoke with the Chair of the committee, David Challoner, MD about the next steps and whether the FDA, pressured by congress and The White House to be pro-medical devices and keep the 510(k) process, will listen to the report or ignore it.