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# Guide on Special 510(k) Program
- URL: https://www.fdaweb.com/guide-on-special-510-k-program/
- Published: 2019-09-13T12:00:00.000Z
- Updated: 2026-09-15T01:49:53.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144997

*Federal Register* notice: FDA has made available a final guidance entitled “The Special 510(k) Program.” The document provides the framework that FDA uses when considering whether a premarket notification 510(k) is appropriate for review as a Special 510(k). To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-09-13/pdf/2019-19881.pdf?ref=fdaweb.com).