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510(k) Third Party Review Program Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations September 2018


Not for implementation. Contains non-binding recommendations.

Docket Number:
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Devices and Radiological Health

This draft guidance provides a comprehensive look into FDA’s current thinking regarding the 510(k) Third Party (TP) Review Program (formerly known as the Accredited Persons Program) authorized under section 523 of the Federal Food, Drug, and Cosmetic Act (FD&C 109Act or Act). This draft guidance describes the recognition, rerecognition, recognition/rerecognition denial, and recognition withdrawal processes, including the 111associated criteria. The objective of this guidance is to encourage harmonization by incorporating elements, where appropriate, from the International Medical Device Regulators Forum’s (IMDRF) regulatory assessment program called the Medical Device Single Audit Program (MDSAP) into the TP Review Program. In addition, the goal of this guidance is to provide FDA’s current thinking on the TP Review Program in the following areas:

  • TP Review Organizations review of 510(k) submissions;
  • Requirements and recommendations for recognition and rerecognition of TP Review Organizations under the TP Review Program;
  • Content and format of a TP Review Organization’s application for initial recognition and rerecognition; and
  • Suspension or withdrawal of recognition

The purpose of the TP Review Program is to implement section 523 of the FD&C Act (21 125U.S.C. § 360m). Section 523 authorizes FDA to accredit third parties to review premarket notification (510(k)) submissions and recommend the initial classification of certain devices. FDA’s implementation of section 523 includes establishing a process of recognition of qualified third parties to conduct the initial review of 510(k)s for certain low-to-moderate risk devices eligible under the TP Review Program.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-2565.