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. The 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
Acceptance reviews are intended to encourage quality submissions to the Agency and ensure a minimum threshold of acceptability is met before the formal review begins. They were put into place to help FDA meet their MDUFA III commitments and ensure timely clearance/approval decisions. The FDA guidance documents referenced above contain objective criteria that must be met before a submission is accepted and allowed to continue in the FDA review process. These criteria are presented in the form of checklists but it’s not quite that simple. As our experience with this new process has grown, we have come to understand more about this new step in FDA’s review process and how to ensure you meet their expectations and requirements. Examples of commonly missed criteria that cause a 510(k) or PMA submission to be rejected, and ultimately delayed, are discussed in the white paper referenced below.
If you are not sure your submission meets the criteria discussed in the guidance documents and would like some assistance, please contact one of our Regulatory experts at namsa.com/contact-us.
A further explanation of the guidances can be found in a white paper entitled The New FDA Refuse to Accept Policy/Acceptance Review Process.