The 3rd Party (3P) Review Program is an alternative process for manufacturers of medical devices to speed decisions on premarket applications for low- to moderate-risk and less complex medical devices. Under the program described in the draft guidance, the sponsor contracts with a CDRH-approved third party organizations (3PO) who then performs an FDA-equivalent review of the proposed device and provide recommendations of the deficiencies in the device. Once those deficiencies have been addressed, the 3PO review documentation may be submitted to the FDA with the 510(k) application. The FDA will review both the application and 3PO documentation, make its final decision on the device, and inform the 3PO, who will then notify the sponsor of that final decision.

The 3P Review program has been available since 1996, first as a pilot program and later signed into law under FDAMA in 1997. FDASIA added requirements for accreditation of 3PO in 2012, and the requirement to issue draft guidance on the 3P program was added under FDARA in 2017. This website describes the program, and includes a link to the plan for eliminating routine FDA rereview targeting the FY2021 goal where 85% of 3P submissions will not require substantive re-review by FDA.

Text Copyright © 2019 Katrina Rogers