Since 2003 FDA staff has used a guidance document to satisfy (21 CFR 814.42(e)) which identifies
the criteria for filing a Premarket Approval (PMA). While this guidance has served its purpose in helping provide a basis for FDA to accept or refuse a PMA, a new guidance was just released, “Acceptance and Filing review for Premarket Approval Applications” which FDA hopes will “clarify the criteria for accepting and filing a PMA, thereby enhancing the consistency of our acceptance and filing decision.”
Overall there are not any drastic changes to the guidance but more information will be readily available to help applicant’s better understand the information needed for review of a PMA. To accomplish this, the new guidance elaborates on two points:
- Acceptance Criteria for PMAs
- Filing Criteria for PMAs
The guidance states that “the purpose of the PMA acceptance and filing reviews is to make a threshold determination about whether an application is complete for the Agency to undertake a substantive review.” To complete the acceptance review FDA will use a Checklist (attached to Guidance) and will have 15 calendar days to finish the review. Once the preliminary review and acceptance decisions indicate that a PMA review should continue, there is an additional Checklist used for filing assessments for PMAs (also attached to Guidance).
FDA anticipates this process will “further focus the Agency's review resources on complete applications, which will provide a more efficient approach to ensuring that devices that have a reasonable assurance of safety and effectiveness reach patients as quickly as possible” according to the news-release.
What have your experiences been with filing a PMA? Do you think this Guidance will provide transparency in the decision-making process? Let us know and comment below!
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