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# Special 510(k) Program Draft Guidance
- URL: https://www.fdaweb.com/special-510-k-program-draft-guidance/
- Published: 2018-10-02T12:00:00.000Z
- Updated: 2026-09-15T00:35:26.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142492

*Federal Register* notice: FDA has issued a draft guidance entitled “The Special 510(k) Program” to clarify existing policy and expand on the types of changes eligible for the program to improve the efficiency of 510(k) review. It includes certain changes to the indications for use and clarifies the types of technological changes that are appropriate to be reviewed as Special 510(k)s. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-09-28/pdf/2018-21141.pdf?ref=fdaweb.com).