Report: Independent reviewer gives FDA pass on review program improvements

On Monday, the FDA said it got a passing grade from an independent assessment group evaluating changes implemented to improve its review process management system starting in 2014.

The changes were based on recommendations given as part of a separate individual assessment, performed by Booz Allen Hamilton, which was performed as part of the Medical Device User Fee Amendments of 2012. The report marks the last deliverable independent assessment agreed to as part of the MDUFA III agreement.

The firm gave the FDA’s Center for Devices and Radiological Health a list of 11 recommendations to improve their review processes after their initial assessment, and the FDA said it has used those points to implement improvements to the system. Booz Allen returned for a phase 2 assessment of changes based on those recommendations.

“As detailed in this report, CDRH successfully completed Stage 1 for each project in its plan of action to address Booz Allen’s recommendations. This marks a significant accomplishment by the center across a broad range of areas in its medical device review program, and satisfies FDA’s commitment to fulfill the recommendations from the independent assessment. If supported and sustained, these improvements implemented are expected to yield meaningful progress toward the shared goals of greater consistency, transparency and predictability in the review process, as well as shorter review times to get products into the hands of patients sooner,” Booz Allen wrote in the review.

The firm offered the caveat that, due to time constraints, it was unable to obtain sufficient observational data to assess the results of most of the projects, leaving only 4 projects completed in time to allow for full data collection.

Booz Allen recommended the CDRH maintain continued analysis of the implemented changes, as well as monitoring long-term outcomes of all implemented projects, to assure the projects “are having the intended impact of the original recommendations.”

The firm said the FDA would have sufficient time to assess the outcomes of the programs beginning in January 2017.

Such an assessment could be used to verify the recommendations are working and “allow for course correction” to avoid investing in projects that may not be as beneficial as intended, according to the report.

While the FDA is looking forward and planning Stage 2 actions that move beyond the initial recommendations, Booz Allen reiterated the importance of a full evaluation of Stage 1 recommendations before moving on.

“Regardless of performing Stage 2 activities, a full evaluation to ensure the impact of the Stage 1 recommendations is being realized could help facilitate a successful rollout of the Stage 2 projects,” Booz Allen wrote in the review.

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