> ## 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.

# 510(k) Third Party Review Guidance Out
- URL: https://www.fdaweb.com/510-k-third-party-review-guidance-out/
- Published: 2020-03-11T12:00:00.000Z
- Updated: 2026-09-14T16:06:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146297

FDA has issued a guidance, *510(k) Third Party Review Program*, describing the process FDA uses to recognize qualified third parties to conduct the initial review of 510(k) submissions for certain low-to-moderate risk device eligible for review under the CDRH Third Party 510(k) (3P510k) Review Program. The [document](https://www.fda.gov/media/85284/download?ref=fdaweb.com) also reflects amendments made by the FDA Reauthorization Act of 2017 that directed the agency to issue guidance on the factors that will be used in determining whether a Class 1 or Class 2 device type or a subset of such device types are eligible for review by an accredited person.

The guidance’s objectives are: **(1)** to describe the factors FDA will use in determining device type eligibility for review by 3P510k review organizations; **(2)** to outline the agency’s process for the recognition, re-recognition, suspension, and withdrawal of recognition for the 3P510k review organizations; and **(3)** to ensure consistent quality of work among 3P510k review organizations through the MDUFA 4 commitments authorized under the FDA Reauthorization Act to eliminate the need for routine, substantive re-review by FDA.