Zdrowie i gospodarka · 25/10/2017

FDA Issues Final Guidance on Submitting 510(k) Pre-Market Notifications for Medical Device Changes

The US Food and Drug Administration (FDA) has released a final guidance document clarifying when a manufacturer must submit a 510(k) pre-market notification for changes to an existing medical device, replacing a 1997 version with an error in the docket number, and updating it to FDA-2011-D-0453.