FDA Begins Pilot of Special 510(k) Program

October 8, 2018

The FDA launched its Special 510(k) program pilot aimed at simplifying the process and expanding the types of product changes eligible for the program.

The launch of the program on Oct. 1 followed the release of draft guidance the previous week in which the agency requested feedback on a proposal to modify the rules of the Special 510(k) program, which forbade modifications to a device’s intended use or labeling.

The pilot will allow stakeholders and FDA staff a chance to test the proposed expansions. As part of the pilot, certain design or labeling changes previously reviewed as traditional 510(k)s may be eligible for review under the Special 510(k) pathway.

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