FDA Launches Pilot on Proposed Expansion of Special 510(k) Program

Regulatory NewsRegulatory News | 03 October 2018 |  By 

On the heels of last week’s draft guidance that proposed expanding the device changes that would be eligible for the Special 510(k) program, the US Food and Drug Administration (FDA) announced Monday the launch of a new pilot to operationalize the planned changes.
All special 510(k)s submitted to FDA’s Center for Devices and Radiological Health after 1 October will be evaluated under the pilot, according to the agency’s website.
The draft guidance set in motion the agency’s goal to increase the number of 510(k) submissions that could be submitted under the program, which is intended to provide a least burdensome approach for expedited reviews and subsequents clearances. It proposes to include certain device modifications and labeling changes to the 1998 program design.
The agency identified three eligibility factors to aid manufacturers in determining whether a device is appropriate for participation. These include a proposed change being made by the manufacturer that obtained 510(k) clearance for the device, performance data are unnecessary or well-established methods for evaluating the change are available and the ability to review these data in a summary or risk analysis format.
“The goal of the pilot is to determine whether updated factors for eligibility in the Special 510(k) Program will improve the FDA staff’s efficiency in reviewing 510(k) submissions,” FDA said.


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