Industry Calls for Metrics on CDRH’s Breakthrough Device Program

Regulatory NewsRegulatory News | 18 January 2019 |  By 

A consensus of industry participants at a US Food and Drug Administration (FDA) webinar on Thursday pressed for metrics on the medical device priority review program run by FDA’s Center for Devices and Radiological Health (CDRH).

The webinar led by Maureen Dreher, policy analyst at CDRH’s Office of Device Evaluation, underscored the need for additional transparency around the Breakthrough Device Program. This request was supported across several participants during the Q&A session that followed Dreher’s overview of the program’s guidance, which was finalized last December. Dreher committed to relaying the request.

Lubna Syed, director of global regulatory affairs at Janssen, argued that “some kind of database listing those products that have received breakthrough designation and a rationale” would help to inform decision-making around whether a candidate medical device will qualify for breakthrough designation.

Formerly known as the Expedited Access Pathway, the Breakthrough Device Program was created by the 21st Century Cures Act of 2016 and the first request for breakthrough device designation was granted in 2017. CDRH currently hosts a large collection of medical device databases with information on its regulatory review pathways, except for that of breakthrough devices. This is in contrast with FDA’s Center for Drug Evaluation and Research and its Center for Biologics Evaluation and Research—both of which separately post metrics on breakthrough therapy designation requests, approvals and withdrawals online.

CDRH director Jeff Shuren reported during a 2018 conference that the center had accepted a total of 65 devices into the Breakthrough Device Program since April 2015 as of last May. Yet a December 2018 statement from FDA Commissioner Scott Gottlieb suggested that the program saw a lot more action toward the end of last year. “Since the program was authorized in late 2016, 110 devices have received a Breakthrough Device designation and eight have received marketing authorization,” Gottlieb said.

The program metrics only trickle out on occasion due to certain confidentiality issues. “At times, we will release the number of granted devices and talk about how many devices have been granted overall in comparison to how many requests we have had,” Dreher said in response to Syed’s request. “But we consider the submissions to be confidential, so we do not release the identity” of the device, she said.

AdvaMed VP of technology and regulatory affairs Steve Silverman suggested during the webinar publishing metrics on the number of breakthrough device designation requests granted versus denied, the percentage of submissions that receive designation and the total time to FDA decision, among others. In response, Dreher said CDRH is “tracking a lot of that information internally and right now it is being used to inform some of the programmatic options and how we operate the program.”

“It is really good to know that there is stakeholder interest in having that information available more publicly,” Dreher added. She explained that this requires additional internal discussion as CDRH has to identify an appropriate mechanism to publish this information.


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