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Game Time: FDA Releases Review Timeline Goals Set By MDUFA V

 
• By Hannah Daniel and Nancy Pham

This exclusive infographic shows new review timelines the FDA announced for FY 2023 now that MDUFA V has been ratified.

• Source: Shutterstock

The Food and Drug Administration has released updated timelines for de novo classification requests, premarket approval applications, and premarket notification 510(k) submissions to comply with the review schedule agreed to under the newly ratified Medical Device User Fee Amendments of 2022 (MDUFA V). The following infographic outlines the FDA’s possible pathways after applications are submitted, as well as what timelines device sponsors can expect.

The new timelines were included in FDA guidance documents released on 3 October.

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