Announcing the Special 510(k) Program Pilot

Announcing the Special 510(k) Program Pilot 

Today, the U.S. Food and Drug Administration (FDA) launched the Special 510(k) Program Pilot, which aims to simplify how manufacturers submit certain 510(k)s. The program pilot allows the FDA and industry to test an expansion to the Special 510(k) Program. 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. The FDA would like to increase the number of 510(k) submissions that are appropriate for the Special 510(k) Program. All Special 510(k)s received on or after October 1, 2018 will be included in the program pilot.

To be eligible for the program pilot, a 510(k) should meet the following eligibility factors: 

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.

On November 8, the FDA will host a webinar to share information and answer questions about the program pilot. More information about the webinar is available at http://www.fda.gov/CDRHwebinar.

If you have any questions, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health at 1-800-638-2014, 301-796-7100 ordice@fda.hhs.gov.