Jan 2014

Authors: Erika Huffman, MSBME, RAC

Excerpt:

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) Premarket Notifications and Premarket Approval (PMA) applications. In the time since the release of the documents, we have come to understand more about this new step in FDA’s review process and how to ensure you meet their requirements.
The two new final guidance documents are:

  • Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff
  • Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administration Staff