US FDA Special 510(k) Program Pilot

On October 1, 2018, the FDA launched the Special 510(k) Program Pilot, which aims to expand on the types of changes eligible for the program to improve the efficiency of 510(k) review. The Special 510(k) Program Pilot provides industry and the FDA staff the opportunity to test this expansion to the existing Special 510(k) Program.

As part of this pilot, certain design or labeling changes that previously were reviewed as a Traditional 510(k) may be eligible to be reviewed through the Special 510(k) pathway instead. The Agency believes that the reliance on design control requirements and previous Agency review of detailed information can reduce review times and still protect the public health. This pilot is part of ongoing efforts to simplify the 510(k) process and help promote timely access to safe, effective, and high-quality medical devices.

What are the eligibility factors for participation in the Special 510(k) Program Pilot?

To be eligible to participate in the Special 510(k) Program Pilot, the following factors should be met for the 510(k):

  1. The proposed change is made and submitted by the manufacturer authorized to market the existing device,

  2. Performance data are unnecessary, or if performance data are necessary, well-established methods are available to evaluate the change, and

  3. All performance data necessary to support substantial equivalence can be reviewed in a summary or risk analysis format.

This pilot is limited to Special 510(k)s for which the lead Center is the Center to Devices and Radiological Health (CDRH).

All Special 510(k)s submitted to CDRH will be considered as part of the pilot. Manufacturers should continue to identify their submission as a Special 510(k). This pilot is intended to clarify and expand the current Special 510(k) Program.

For more information on the Special 510(k) Program, check out the following link:


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