In December, CDRH published a report by consultant group Booz Allen Hamilton evaluating the results of the plans established by CDRH to improve the medical device review process. These plans were based on the recommendations from phase 1 of the assessment (also performed by Booz Allen) on the best practices and improvements that would promote “predictable, efficient, and consistent premarket reviews”.* The entire assessment process was mandated through the Medical Device User Fee Amendments of 2012 and 2017 (MDUFA III and IV, respectively). These amendments to the FD&C Act specified 2 assessments during MDUFA III (FY2014-FY2017) and at least 1 in MDUFA IV, all with the focus of improving CDRH operations. The summary finding of the report is “CDRH’s efforts have been very effective at standardizing CDRH operations, increasing staff knowledge to perform submission reviews, increasing regulatory process clarity, and improving decision-making consistency”. Some additional opportunities for improvement exist in the areas of performance metrics, better search capabilities within CDRH systems, and improving electronic submissions.  The 11 progress areas in the report are focused on internal improvements only. There’s no information on the impact to the customer or direct data showing how these process improvements led to more timely access to safe and effective medical devices.

*Quotes are from the MDUFA IV report.

Text Copyright © 2019 Katrina Rogers