CDRH Industry: Final Evaluation of the MDUFA III Independent Assessment of the Premarket Review Program

Today we posted the Final Implementation Evaluation Report of an independent assessment of CDRH’s premarket review program. The assessment, conducted by Booz/Allen/Hamilton, was part of FDA’s performance commitments under the 2012 reauthorization of the Medical Device User Fee Amendments (MDUFA III). It focused on CDRH’s premarket review processes and identified opportunities for improving the review of device premarket applications. Today’s report details the success of CDRH’s implementation of the assessment recommendations.

The assessment was conducted in two phases. In the first phase of the assessment, Booz/Allen/Hamilton identified process improvements to promote predictable, efficient, and consistent premarket reviews that meet FDA’s regulatory standards. In December 2013, we posted their preliminary report, which featured four priority recommendations they deemed likely to have a significant impact on review times. This was followed by an FDA Plan for Priority Recommendations, in June 2014. Booz/Allen/Hamilton’s final report, released to the public in June 2014, expanded on the priority recommendations and detailed an additional seven recommendations for improvements in the submission review process, information technology (IT) infrastructure, training and retention policies and practices, and quality management (QM) systems. In December 2014, CDRH posted a Plan of Action to address each of the eleven Phase 1 recommendations.

In Phase 2, Booz/Allen/Hamilton evaluated FDA’s implementation of the recommendations from the Phase 1 assessment. We are proud of our progress in implementing these recommendations. We have successfully completed each project in our Plan of Action to address Booz/Allen/Hamilton’s recommendations. For detailed information about the evaluation and its findings, please see the Final Implementation Evaluation Report.