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CDRH Program Seeks to Resolve 510(k) Issues in New Way

Posted 15 March 2019 | By Ana Mulero 

CDRH Program Seeks to Resolve 510(k) Issues in New Way

A quietly-launched pilot at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) was implemented last Monday to evaluate a new approach to resolving issues in 510(k) submissions.

“CDRH is implementing the least burdensome flag as a program for 510(k) submissions to act as a performance metric for the implementation of least burdensome requirements,” said Joshua Silverstein, regulatory advisory at CDRH’s Office of Device Evaluation (ODE), during a CDRH webinar on Thursday.

The webinar provided an overview of the updates to older concepts and principles set forth via February final guidance on the FD&C Act’s least burdensome provisions. CDRH kicked-off the webinar with legislative background, feedback on the draft version and the least burdensome final guidance itself. The focus then shifted toward the new pilot initiated last year, known as the least burdensome flag pilot.

Prior to the webinar, the least burdensome flag pilot had barely been discussed by CDRH. The center had not informed through the traditional channels for such initiatives that it ran a least burdensome flag pilot from February 2018 through September 2018 across seven review branches within ODE. CDRH Director Jeff Shuren then touched on the least burdensome flag pilot during a summit last November. Shuren touted the pilot as an “opportunity for sponsor to ‘throw flag’ during review,” like in the NFL when a coach can throw a flag to question a referee’s call.

Silverstein noted: “We were able to capture data by requesting feedback from one third of submitters who did not use the flag and all submitters who did use the flag…The pilot sought to answer questions related to customer satisfaction, efficiency, and submission outcomes.” A total of 132 letters were given the opportunity to use the least burdensome flag. Only two submitters (1.5%) used the flag in the pilot.

Those who did not use the least burdensome flag during the pilot reportedly found other methods to resolve the issues, such as daytime phone call, or believed the deficiencies were reasonable, while a few others thought the pilot was too restrictive. The two submitters that did use the flag said they would prefer using this approach rather than an appeals process.

The agency’s review staff was still able to meet the self-designated 21-day deadline for turnaround on used flags “because each flag was resolved in a straightforward manner,” according to Silverstein. “We believe that the straightforward resolution was due to limiting the flag two topic areas,” he said.

The feedback received post-pilot led to the conclusion that the flag approach is simpler than an appeal.

The program, which has been in effect since 4 March, can be used by sponsors seeking to resolve issues in their submissions. Silverstein outlined the steps sponsors can chose to follow when looking to use the least burdensome flag, the criteria for appropriate use and expectations for submitters using the flag.

A two-topic area limit on flags and a deadline to use the flag within 60 days are some of the new criteria.

510(k) Landscape

The least burdensome flag program comes at a time when CDRH has worked to overhaul all of its existing 510(k) programs, including the traditional 510(k) pathway, the special 510(k) pathway and the abbreviated 510(k) pathway, in addition to the introduction of a new pathway. Some of these efforts are centered on modernizing regulatory approaches, while others seek to expand medical device eligibility.

The new Safety and Performance Based Pathway for 510(k) submissions builds on the framework of abbreviated 510(k)s in that it seeks to provide additional flexibility through greater use of device performance testing criteria and consensus standards rather then direct comparison testing.

Yet another 510(k) pilot, deemed the Quality in 510(k) program, was launched last September. CDRH has also been piloting an expansion of the special 510(k) program since last year for greater device eligibility.

The agency also recently proposed limiting use of older predicate devices to support 510(k) submissions.

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