CDRH Issues Plan of Action Based on Booz Allen Hamilton’s MDUFA II/III Evaluation Priority Recommendations

By Allyson B. Mullen –

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 outside assessment of the medical device review process.  The assessment was performed by Booz Allen Hamilton ("Booz Allen").  On December 11, 2013, Booz Allen released its initial report with 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; and
• Adopt a holistic, multi-pronged approach to address five quality component areas to standardize process lifecycle management activities and improve consistency of reviews.

See our earlier post here.
 
On June 11, 2014, Booz Allen issued its final report and CDRH issued its Plan of Action ("the Plan").  The final report makes 11 recommendations, including, among other things, that CDRH conduct a retrospective review of withdrawn premarket submissions to identify the cause of the withdrawal.  The report cites a fifty percent increase in 510(k) withdrawals from fiscal year 2012 to fiscal year 2013.

While the final report issues 11 recommendations, several with subparts, the CDRH Plan focused on the four priority recommendations from Booz Allen’s December 2013 report.  It is unclear whether CDRH will update the Plan to address the remaining recommendations in the final report.

The CDRH Plan of Action, which reads somewhat like a FDA Form 483 response by a device manufacturer, outlines actions with respect to each of the four priority recommendations.  With regard to the first recommendation, “develop criteria and establish mechanisms to improve consistency in decision making throughout the review process,” the Plan indicates that CDRH will inventory and perform a gap assessment of its existing processes, procedures, policies and metrics relating to premarket applications (510(k)s, PMAs, 510(k) requests for Additional Information, PMA Major Deficiencies, and IDE approval decisions).   Once complete, CDRH plans to identify lessons learned and best practices for decision making from other organizations and then develop new premarket application review processes, procedures, and policies with the intent of streamlining the process.  One hopes that these new processes, procedures, and policies will speed up the review process.  However, at least one recent attempt to improve the quality of 510(k)s has, in some cases, slowed down the process with a rigid and formalistic process (see our earlier post here).  Although unaddressed in the CDRH Plan, the Booz Allen final report acknowledges that the greater than 50% refusal rate during the first round of RTA reviews for 510(k)s is problematic for the overall review process, and optimization of the RTA process is one of the 11 recommendations in the final report. 

As to the second recommendation, “provide mandatory full staff training for the three primary IT systems that support MDUFA III reviews,” the Plan indicates that after completing a review of the current IT systems, CDRH will incorporate training on these systems into the CDRH Reviewer Certification Program (RCP).  Following this implementation, CDRH plans to create a group of experts on the systems, which presumably will be available to reviewers in need of assistance.  In a second stage of this part of the Plan, CDRH intends to broaden its efforts in reviewing and identifying gaps with regard to training on other IT processes.

The Plan for the third recommendation, “identify metrics and incorporate methods to better assess review process training satisfaction, learning, and staff behavior changes,” is short and simple.  CDRH will research best practices for training evaluation, determine evaluation requirements for premarket training, develop metrics and evaluation plan, and implement the same. 

The portion of the Plan for the final recommendation, “adopt a holistic, multi-pronged approach to address five quality component areas to standardize process lifecycle management activities and improve consistency of reviews,” is by far the most significant, in both length and potential impact to the effectiveness of the CDRH premarket review process.  There are four parts of this section of the Plan: (1) Senior Management, Corrective and Preventative Action and Continuous Process Improvement; (2) Resource Management; (3) Document Management; and (4) System Evaluation.  Sections 1 and 3 address the need to assess and identify gaps in current processes related to the relevant areas, and revise and implement new processes related to the same.  The Resource Management Section indicates that these recommendations are addressed in other areas of the Plan.  Finally, the System Evaluation section indicates that CDRH will review and evaluate the processes for monitoring review of 510(k) sub-processes. 

While there no hard deadlines for any of the actions set out in the Plan, in a blog post from Jeffrey Shuren, Director of CDRH, he said that the immediate actions related to the four priority recommendations, outlined both above and in the Plan, will be complete by the end of 2016.  Jeffrey Shuren, FDA Voice, Report: CDRH on Track to Improve Device Submission Review Process, June 11, 2014.

No timeline was given for the remaining actions in the Plan, which Dr. Shuren described as covering “longer-term actions to further enhance the efficiency of [CDRH’s] processes beyond what [Booz Allen] recommended.”  We look forward to seeing the implementation of all of the actions in the Plan and hope there is a positive affect on device premarket reviews.