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April 2, 2025
Approximately 5 minutes
How Long is the FDA Review Process for 510(k) Medical Device Submissions? (MDUFA III Goals)
FDA 510(k) Review Timeline: MDUFA III Performance Goals
The US Food and Drug Administration (FDA) provides a clear communication timeline for the review of 510(k) Premarket Notifications to establish predictability and transparency for medical device manufacturers. This timeline is structured according to the performance goals set forth by the Medical Device User Fee Amendments of 2012 (MDUFA III).
🗓️ Key Review Milestones
The FDA's goal is to issue a final clearance decision for most 510(k) applications within 90 calendar days. The process is broken down into the following key communication stages:
| Review Stage | Timeframe (Calendar Days) | FDA Action / Outcome |
|---|---|---|
| Acceptance Review | Within 15 days | Initial decision on whether the submission is complete and accepted for substantive review. |
| Substantive Review | Within 60 days | Initial decision on whether the submission meets the requirements for clearance, often leading to an initial communication of deficiencies or questions. |
| Final Decision | Within 90 days | Issuance of the final clearance or denial decision. |
| Notification of Issues | Within 100 days | Applicants with outstanding review issues or who require additional information (AI) from the FDA will be officially notified. |
The MDUFA III goals and the corresponding communication chart were established partly in response to industry concerns regarding unpredictable and inconsistent requests for additional information, which had often caused significant registration delays.
While this chart outlines the FDA’s performance goals for the review process, the actual duration can still vary based on the complexity of the device and the time taken by the manufacturer to respond to any Requests for Additional Information (AI). A timely and complete response is crucial for achieving clearance within the 90-day goal.
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