As part of the negotiation for re-authorization of user fees under Medical Device User Fee Amendments (MDUFA) II/III, FDA and the medical device industry agreed to an independent, comprehensive assessment of the medical device submission review process. Booz Allen Hamilton, a management consulting firm, was selected to perform the year-long assessment.
On June 11th, Booz Allen Hamilton released their 147-page report which provides some pretty interesting insight to the review process. The report includes descriptions of the methodology used, detailed results and recommendations based on their findings and analysis. Booz Allen presented 11 recommendations intended to improve FDA’s review process; 4 were classified as high priority.
On the same day, FDA released their plans for addressing the 4 high priority recommendations.
The report is a must-read for regulatory professionals as it provides insight regarding the challenges experienced by both industry and CDRH (Center for Devices and Radiological Health) during the device-review process and portends what the future may hold.
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- Review Booz Allen Hamilton’s Independent Assessment of FDA Device Review Process Management.
- Read the full response from the FDA in the Center For Devices And Radiological Health’s Plan Of Action.