RTA Policy for 510(k) Submissions

RTA Policy for 510(k) Submissions

by | Aug 5, 2015 | FDA

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) plans to implement changes to its Refuse to Accept (RTA) policy for 510(k) medical device submissions on October 1, 2015, according to new guidance from the agency. The latest RTA...