510(k) Third Party Review Program: New FDA's Draft Guidance Available

In an effort to encourage harmonization, the guidance refers to standards described in the International Medical Device Regulators Forum (IMDRF) documents as criteria FDA will consider for recognition, re-recognition or the denial or withdrawal of recognition of third-party review organizations under the program.

While issuing the guidance, FDA joined with the IMDRF’s Medical Device Single Audit Program’s (MDSAP) Regulatory Authority Council in encouraging device manufacturers to participate in MDSAP, which is expected to begin the transition from a pilot phase to full implementation on 1 January 2017.   

MDSAP enables device manufacturers to contract with an authorized Auditing Organization (AO) to conduct a single audit against the relevant medical device regulatory requirements of all fully participating regulatory authorities, which includes Australia's Therapeutic Goods Administration (TGA), Brazil's National Health Surveillance Agency (ANVlSA), Japan's Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) and Health Canada.

Draft Guidance

The third-party review program, according to FDA, is intended to enable the agency to focus more of its internal scientific review resources on higher-risk and complex devices, while maintaining a high degree of confidence in the review of low-to-moderate risk and less complex devices by the authorized review organizations under the program.

The outsourcing of such reviews also provides manufacturers of eligible devices a voluntary alternative review process “that may yield more rapid 510(k) decisions from FDA,” the draft says.

Under the program, the review organizations conduct the equivalent of an FDA premarket review of a 510(k) submission, and then forward their reviews, recommendations and 510(k) submissions to FDA for a decision concerning the substantial equivalence of a device.

FDA is required to issue a determination within 30 days after receiving a recommendation from such authorized organizations, which currently include BSI Healthcare and Tuv Sud America.

The process for such a 510(k) review is outlined below:

The guidance also outlines the content and format of an application for initial recognition and re-recognition as a third-party review organization, as well as the requirements and recommendations for such a designation as such an organization.

The new draft replaces draft guidance from February 2013, entitled “Accreditation and Reaccreditation Process for Firms under the Third Party Review Program: Part I; Draft Guidance for Industry,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.”

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