Booz Allen: More Time Needed to Show Effects of CDRH’s Device Review Reforms

CDRH is making significant progress to improve its medical device review program, but it’s too early to tell if the efforts will have long-term effects, Booz Allen Hamilton says in an independent assessment report.

The report, released by the FDA last week, says the agency has successfully completed Stage 1 for each project in its December 2014 Plan of Action to address 11 recommendations made by Booz Allen in June 2014.

“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 says.

The assessment showed that three of the projects and part of another project were completed in time to allow for data collection and analysis of initial results, including:

• The use of a new online issue reporting and tracking system on the QM program site;
• Completion of mandatory training on premarket review systems, and awareness of a newly designated cadre of IT experts;
• Deployment and collection of Kirkpatrick metrics; and
• Awareness of new informal training policies and procedures.

However, there was insufficient time to assess both the initial results of most of the implementation projects, as well as the long-term outcomes of any of them.

The assessment was part of FDA’s performance commitments under the 2012 reauthorization of the Medical Device User Fee Amendments. Read Booz Allen’s report here: www.fdanews.com/02-16-FDAReport.pdf. — Jonathon Shacat