CDRH Issues Final Plan of Action in Response to Booz Allen Hamilton Evaluation

The CDRH has responded to the Booz Allen Hamilton evaluation of the medical device review process that occurred as part of the implementation of the Medical Device User Fee Act (MDUFA) that passed in 2012. Although the final report was published in June of 2014, it came with a 'plan of action' that detailed what the firm felt were priority items for the FDA's improvements agenda.

The official response uses the same verbiage as the Booz Allen Hamilton recommendations, ('Center for Devices and Radiological Health's Plan of Action'), and carries a 'final report' subtitle, as it takes the place of an initial action plan that was published in the summer of 2014.

The CDRH has adopted many of the key points made by Booz Allen Hamilton, including the need to improve on the FDA's ability to standardize the consistency of both its review process and the reviews themselves. This will be tackled by a multi-stage plan to improve on the feedback mechanisms associated with the CDRH's lifecycle management activities, as well as by taking a second look at the systems used in monitoring the quality of the review process.

Also on the docket: better resource management (by way of re-evaluating training programs, IT infrastructure, and workload management), document management (via a revised document control system), the optimization of the RTA process, a reduction in the number of withdrawn submissions, improving sponsor communication, and the implementing staff transition and succession plans to help deal with employee turnover.

The FDA has pledged to initiate each of these action items prior to the end of the 2015 calendar year. Medical device companies will undoubtedly benefit from the successful execution of these plans, especially considering the potential for improved engagement between the Agency and industry players, along with the quicker review times and more consistent feedback that should result from further transparency and process streamlining.

0 2008-01-18T13:10:54 Administrator


  • Medical Device