Booz Allen Hamilton’s Priority Recommendations for Device Review Come as No SurpriseDecember 16, 2013
As part of the Medical Device User Fee Act of 2012 (MDUFA III) Commitment Letter, FDA and the medical device industry agreed to participate in a comprehensive assessment of the medical device review process. MDUFA III Commitment Letter (April 18, 2012), at 12. FDA contracted with Booz Allen Hamilton to conduct the two-phase assessment. The results of the first phase are to be issued within one year of the contract award, with findings on a set of priority recommendations within six months.
On December 11, 2013, Booz Allen released its report detailing the following priority recommendations:
- Develop criteria and establish mechanisms to improve consistency in decision making throughout the review process
- Provide mandatory full staff training for the three primary IT systems that support MDUFA III reviews
- Identify metrics and incorporate methods to better assess review process training satisfaction, learning, and staff behavior changes
- Adopt a holistic, multi-pronged approach to address five quality component areas to standardize process lifecycle management activities and improve consistency of reviews
For anyone who follows FDA’s medical device review processes, none of these recommendations should come as a surprise. Industry has, for years, been encouraging CDRH to improve consistency in decision making, and has been very vocal in its criticism of CDRH’s failure to do so. Time and again, we learn of situations, for example, in which CDRH requests data in a 510(k) submission that were not required of a recently cleared predicate, or where CDRH relies upon a draft guidance or a policy that has not been communicated to industry.
The second and third points relate to CDRH’s lack of sufficient and/or efficient training of its reviewers. Once training is complete, there is little to no follow-up to determine whether the training achieved its goals, and if additional training is necessary. With respect to the IT systems, Booz Allen found that only 53% of reviewers who received training on the new IT systems found that the training eased review. As for training programs intended to “increase knowledge on submission review for both new and experienced staff,” Booz Allen found “gaps in FDA’s ability to objectively assess the impact of learning and the extent to which participants’ review behaviors changed as a result of training.” It is not clear from the report whether FDA has in place processes to assess the impact of training—if it does, this would come as a surprise—or whether the lack of training assessment itself is the gap. Either way, FDA should find a way to determine whether its training programs are beneficial.
Finally, the last bullet encompasses many of the issues identified in the prior bullets. The five quality component areas include Senior Management Responsibility, Resource Management, Document Control, Process Improvement, and System Evaluation. Booz Allen’s recommendations with respect to these five areas relate primarily to ensuring accountability and follow-up with respect to both review issues and training, establishing consistency in document control, formalizing a means of making improvements to the review process, and better monitoring the quality and effectiveness of the review process.
All areas identified by Booz Allen are ones in which industry has long been encouraging CDRH to make improvements to its system. Perhaps because these recommendations stem from the MDUFA Commitment Letter, rather than simply frustrated industry representatives, CDRH will pay more attention this time. However, for many in the industry, the report will likely just be seen as more recommendations to CDRH of areas that need improvement that will go unheeded.