RTS Archive: The New FDA Refuse to Accept Policy for 510(k)s and Acceptance Review Process for PMA
So you have a 510(k) or PMA submission prepared and are ready to send it to FDA for review. . . or are you?
On December 31, 2012, the US Food and Drug Administration (FDA) released two final guidance documents outlining new acceptance review processes that apply to 510(k)s and Premarket Approval (PMA) applications. In the 6 months since the release of the documents, NAMSA has come to understand more about this new step in FDA’s review process and how to ensure you meet the requirements.