Acceptance and Filing Review for PMA Applications - Guidance Part 1
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The purpose of the PMA acceptance and filing reviews is to make a threshold determination about whether an application is administratively complete for the Agency to undertake a substantive review.
Review policies for filing
Once the application is found to be administratively complete, FDA staff should notify the applicant that the PMA has been accepted and begin the filing review according to the Checklist for Filing Review. The objective of the filing review is to determine the basic adequacy of the technical elements of the PMA. In order for the submission to be filed, the application should be sufficiently complete to permit a substantive review. Once the filing review is complete, staff will notify the applicant in writing within 45 calendar days of receipt whether the PMA has been “Filed” or “Not Filed.” See 21 CFR 814.42(a). If the PMA has been “Filed,” the agency will identify the date of receipt of the PMA or of the amendment to the PMA that enabled FDA to file the PMA.
The Checklist – Filing Review
If the answers to the above preliminary questions and acceptance decision questions indicate that PMA review should continue, the formal filing review should proceed by answering questions in the “Filing Review” section of the checklist. This section of the checklist assesses the basic adequacy of the technical elements (i.e., “Filing Assessment of Technical Elements”) and guides FDA staff through the process necessary to arrive at a decision to “File” or “Not File” a PMA.
The specific issues that are critical to the PMA filing decision-making process (i.e., the “Filing Decision Questions”) are individually discussed below. The numbering scheme used for these decision questions corresponds to that of the checklist. Each Filing Decision Question should be answered. Only if all questions are answered “Yes” can the PMA application be filed.