> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guide on 510(k) Third-Party Reviews
- URL: https://www.fdaweb.com/guide-on-510-k-third-party-reviews/
- Published: 2024-11-21T12:00:00.000Z
- Updated: 2026-09-14T14:47:49.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158235

*Federal Register* notice: FDA is making available a final guidance entitled “510(k) Third Party Review Program and Third-Party Emergency Use Authorization (EUA) Review.” The document provides the agency’s current thinking regarding the alternative process for manufacturers to seek 510(k) submission reviews and EUAs. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-11-21/pdf/2024-27085.pdf?ref=fdaweb.com).