Life Sciences Advisory: FDA to Begin Revamping the 510(k) Medical Device Review Program
1/25/2011
By Dianne J. Bourque and Ellyn L. Sternfield
On January 19, 2011, the Food and Drug Administration (FDA) announced that some much criticized recommendations—such as the creation of new device classifications for which additional evaluation is necessary for 510(k) clearance, the creation of grounds for full or partial rescission of 510(k) clearance, and the creation of authority for the FDA to consider off-label use in certain circumstances when determining “intended use” of a device under 510(k) review—had been put off at least until the summer of 2011. These recommendations had been made by a Working Group and Task Force that the FDA had established in September 2009.
