510(k) Third-Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third-Party Review Organizations; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``510(k) Third-Party Review Program; Draft Guidance for Industry, Food and Drug Administration Staff, and Third-Party Review Organizations.'' This draft guidance provides a comprehensive look into FDA's current thinking regarding the 510(k) Third-Party (3P) Review Program authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the FDA Reauthorization Act of 2017 (FDARA), FDA was directed to issue draft guidance on the factors that will be used in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person. The 3P Review Program is intended to allow review of devices by 3P Review Organizations to provide manufacturers of these devices an alternative review process that allows FDA to best utilize our resources on higher risk devices. This draft guidance is not final nor is it in effect at this time.