Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)

In addition to the Refuse to Accept Policy for 510(k)s Guidance document I discussed in my previous post, the FDA also issued a guidance titled Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) at the same time.

This link provides a good summary of the changes made to both of these guidance documents. It also states that the PMA guidance document is not much different from the previous version. One of the main changes was the review process for PMAs will now be in two steps (similar to the 510(k)). The first step of the review is for administrative purposes, to see if there is any missing content (without looking into the quality of that content). This has to happen within 15 days of receiving the submission. The second step is called a filing review. This "determines the basic adequacy of the technical elements of the PMA". So this step digs more into the content of the data but not is a formal substantive review. The FDA has to notify the applicant within 45 days of this review.

It will be interesting to see what people are saying about both of these documents and if they feel it benefits both the FDA reviewers and the applicants.

--Jillian F. Walker