USA – MDUFA Report Touts CDRH Efforts to Improve Medical Device Review Processes

Efforts at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) to improve the medical device review process under the Medical Device User Fee Amendments of 2012(MDUFA III) “have been very effective,” found a new report developed by Booz Allen Hamilton, a management and information technology consulting firm.

The report satisfies a requirement under the latest MDUFA reauthorization and covers the second of two phases Booz Allen had set as part of its framework to conduct an independent assessment of how CDRH staff worked to implement 11 recommendations identified in 2014 in the phase 1 report and adopted in a Plan of Action the center subsequently issued. It provides initial results and assesses the overall impact of phase 2 implementation projects based on the recommendations Booz Allen offered.

“Booz Allen determined that CDRH staff are aware of and utilize the products and resources developed and implemented by CDRH for all recommendations,” according to the report, issued late last December. “Further, most of CDRH’s implementation projects met the intent of the recommendations and several projects have progressed far beyond the original recommendations. Overall, 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.”…