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# Draft Guide on 510(k) Third-Party Review Program
- URL: https://www.fdaweb.com/draft-guide-on-510-k-third-party-review-program/
- Published: 2018-09-14T12:00:00.000Z
- Updated: 2026-09-15T00:32:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142356

*Federal Register* notice: FDA has made available a draft guidance entitled “510(k) Third-Party Review Program.” The [document](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM339697.pdf?ref=fdaweb.com) reflects amendments made to the third-party review program by the FDA Reauthorization Act of 2017, which directed the agency to issue draft guidance on the factors that will be used in determining whether a Class 1 or Class 2 device type, or subset of such device types, is eligible for review by an accredited person. The guidance is intended to **(1)** describe factors FDA will use in determining device type eligibility for review by third-party reviewer organizations; **(2)** outline the agency’s process for the recognition, re-recognition, suspension, and withdrawal of recognition for third-party reviewer organizations; and **(3)** ensure consistent quality of work among third-party reviewer organizations through the MDUFA 4 commitments authorized under the FDA Reauthorization Act. To view the notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2018-09-14/pdf/2018-19992.pdf?ref=fdaweb.com)