New Guidance from US FDA May Mean Just One Thing for Medical Device Manufacturers –
More 510(k)s

August 1, 2011

At first glance, the draft guidance that the US Food and Drug Administration has issued on when to submit a new 510(k) pre-market notification for a change to an existing device does not appear to be too different from its 1997 predecessor. Both the new document, announced on July 26th, and the one it will replace when finalised claim to focus on the meaning of whether a modification may “significantly affect” the safety or effectiveness of the device.

This article was published in the August 2011 issue of Scrip Regulatory Affairs (see