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FDA Issues Draft Guidance for 510(k) Third Party (TP) Review Program

Today, the U.S. Food and Drug Administration (FDA) released a draft guidance document entitled “510(k) Third Party Review Program.” The purpose of this draft guidance is to explain the FDA’s 510(k) Third Party (TP) Premarket Review Program, formerly known as the Accredited Persons (AP) Program. Under the FDA’s TP Premarket Review Program, authorized by federal law, recognized organizations are allowed to review certain eligible low-to-moderate risk 510(k) devices, which may yield faster 510(k) decisions.

Within this draft guidance, the FDA proposes criteria of the TP Premarket Review Program in the following areas:

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

This draft guidance replaces the 2013 draft guidance entitled “Accreditation and Reaccreditation Process for Firms under the Third Party Review Program: Part I – Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Reviewers.” Additionally, in an effort to harmonize the terms used by the International Medical Device Regulators Forum’s (IMDRF)regulatory audit program called Medical Device Single Audit Program (MDSAP), this draft guidance uses terms such as “recognition and rerecognition” instead of “accreditation and reaccreditation.”

We welcome your comments and suggestions regarding this draft guidance.  The comment period will be open for 120 days in the Federal Register under docket number FDA-2016-D-2565 starting September 12, 2016.

If you have any questions, please contact the Center for Devices and Radiological Health (CDRH) Third Party Review Program at 3P510K@fda.hhs.gov.

Food and Drug Administration
Center for Devices and Radiological Health