The Medical Device User Fee Amendments of 2012 ("MDUFA III") require FDA to “publish guidance outlining electronic copy of submissions ("e-Copy") and objective criteria for revised ‘refuse to accept/refuse to file’ checklists.” On July 30, 2012, FDA issued a draft guidance in response to this commitment, titled “Acceptance and Filing Review for Premarket Approval Applications (PMAs).”
The draft guidance is intended to provide FDA staff with a “clear, consistent approach to making acceptance and filing decisions on original PMA applications and panel-track PMA supplements.” Though similar to the PMA filing checklist and guidance document issued in 2003, the draft guidance makes three modifications: 1) it divides the filing criteria into two distinct sets of criteria, acceptance criteria and filing criteria; 2) it encourages applicants to provide one electronic copy of the PMA in place of one of the six hard copies of the PMA application, and; 3) it includes manufacturing information as one of the sections required for a PMA to be considered complete.
Dividing the filing criteria into two checklists allows reviewers to reach an earlier decision about whether the PMA is sufficiently complete to allow the review to proceed. Within 15 calendar days of receipt of the PMA, the reviewer must consider the preliminary questions (e.g., is the product a device, is appropriately reviewed under the PMA pathway) and determine whether the acceptance criteria have been met. These criteria include all organizational and administrative elements, or a rationale for why certain elements are not included. If the application contains all required elements, FDA should inform the applicant in writing that the application has been accepted. If FDA fails to complete the acceptance review within 15 days, the application is considered accepted.
If the reviewer determines certain elements are missing, he should obtain concurrence from his supervisor, and then issue a letter to the applicant identifying the missing elements. If the applicant provides the missing information, FDA will again have 15 days to review the acceptance elements.
Once FDA accepts the application, it reviews the application for the elements contained in the filing checklist to “determine the basic adequacy of the technical elements of the PMA.” To be filed, the application must be “sufficiently complete to permit a substantive review.” FDA has 45 calendar days from date of receipt of the PMA within which to complete the filing review.
The draft guidance includes two checklists, one for acceptance criteria and one for filing criteria. When compiling a PMA, these checklists can assist sponsors in assuring that the PMA includes all the information required by FDA, which in turn can help FDA accept and file the PMA in a more timely manner.