510(k) Third Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``510(k) Third Party Review Program.'' This draft guidance provides a comprehensive look into FDA's current thinking regarding the 510(k) Third Party (TP) Review Program authorized under section 523 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In an effort to encourage harmonization, this guidance proposes to refer to, for the purpose of the TP Review Program, where appropriate and consistent with the FD&C Act and other applicable laws and regulations, the elements from the International Medical Device Regulators Forum's regulatory assessment program called the Medical Device Single Audit Program. In addition, the Food and Drug Administration Safety and Innovation Act (FDASIA) requires FDA to establish and publish in the Federal Register criteria to reaccredit and deny reaccreditation of TP Review Organizations. Those criteria, including others, are described in this draft guidance. This draft guidance is not final nor is it in effect at this time.