Dec 12, 2013


A new report commissioned by the US Food and Drug Administration identifies four broad areas where the regulator should improve its methods for clearing or approving medical devices for sale.

Mandated by the Medical Device User Fee Act of 2012 (MDFUFA III) and issued by Booz Allen, the report targets decision making, technology training, metrics and standardization processes needed to boost efficiency of FDA 510(k) premarket notification and Premarket Approval (PMA) device reviews. Recommendations include:

  • Establishing criteria to develop more consistent decision making in the course of market authorization reviews
  • Mandatory full staff training on all three major IT systems used for MDUFA III reviews
  • Using appropriate metrics to effectively assess review training and learning of staff
  • Standardizing process lifecycle management processes for more consistent reviews

Booz Allen recommended a five-part quality framework similar to quality system requirements for medical device manufacturers for improving project management efforts by FDA staff. These recommendations cover senior management accountability, resource management including regular training, document management and control system improvements, formalized corrective and preventative action (CAPA) processes, and quantitative system evaluations.

How will the FDA treat these recommendations?  Evaluations of FDA device review processes will continue until late 2014, when a final report and recommendations will be made public. The US medical device industry has not been shy about suggesting improvements to PMA reviews, but such suggestions have often not been solicited (or, in some instances, welcomed) by the agency. This time, under the auspices of MDUFA III, the Booz Allen recommendations stand a better chance of eventual implementation.

Stewart Eisenhart


  • Stewart Eisenhart