medical device review

Efforts at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) to upgrade 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.”

The 11 recommendations involved corrective and preventive actions, document control enhancements, review process metrics, decision-making consistency, refuse-to-accept (RTA) process improvement, withdrawn submission analysis, sponsor communications, IT system training, eCopy guidance, workload management tool review, training program evaluation and metrics, promoting informal training as well as staff turnover and transition plans. The latest report also completes the final stage—aimed at assessing whether projects helped achieve the desired outcomes—of Booz Allen’s MDUFA framework.

The report’s initial results show that the percentage of traditional 510(k)s accepted by CDRH the first time around increased from 64% in fiscal year (FY) 2015 to reach a total of 71% in FY 2017. The percentage and number of submissions without eCopy holds saw a 92% spike in 2017 compared to 74% in 2013. And out of 7,558 traditional 510(k)s that received MDUFA decisions between FY 2015 through FY 2017, only 174 submissions (2%) had missed the 90-day goal set under the user fee legislation.

“Overall, CDRH’s action have positively impacted efforts to enhance and upgrade medical device review processes submission review,” Booz Allen added in its 61-page, data-driven report. The firm identified several additional opportunities for CDRH to pursue that are aimed at building off the success of implemented efforts. These incorporate “upgraded survey execution measurements and examination, better pursuit capacities inside CDRH IT frameworks, and actualizing assets to encourage organized electronic entries.”

Booz Allen also pointed to more recent CDRH efforts in the areas of operations, staff training and submission process management. These include CDRH’s 2018-2020 strategic priorities, a proposed rule that would remove the requirement for sponsors to submit multiple paper copies and the introduction of CDRH’s new Quality in 510(k) Review program pilot centered on assessing use of Submitter software.

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