USA – Device makers seek transparency on Breakthrough Devices Program

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…