In August 1996, the FDA launched what was known as the Voluntary Third Party 510(k) Review Pilot Program. The program’s aim was to test out the usage of third parties for performing primary reviews of some medical devices under the 510(k) process in order to improve speed and efficiency. The limitation of the device eligibility was quite significant, allowing only those class I devices that were not categorized as exempt and only thirty class II devices.
When the Food and Drug Administration Modernization Act (FDAMA) became law in November 1997, it included an expansion of the pilot program, which was included in Section 523 of the FD&C Act, under the Accredited Persons (AP) Program. The FDA provided training for the third parties and formally accredited them under the Program. Many of the third parties that participated in the AP Program were also Notified Bodies in the European Union. Having similar experience with reviewing both product design and regulatory technical data under the then New Approach Directives, it seemed to be a logical fit. Still focusing on public safety as it’s number one goal, by using accredited bodies, the FDA would not only maintain a high level of confidence in the review process at the low and medium level devices, but also be allowed to use its valuable internal resources for higher risk and more complex devices. Of course, use of third parties is completely voluntary, so the public’s participation in the program is the deciding factor for the success of the program.
The AP Program is now known as the 510(k) Third Party Review Program (3P510k). Third parties would receive a 510(k) submission from a manufacturer, make a formal review and submit both the review and 510(k) submission to the FDA along with their recommendation of either substantially equivalent (SE) or not substantially equivalent (NSE). From there, the FDA would make its final decision within thirty (30) days, a requirement in the FD&C Act. Manufacturers pay the third parties for their review and the third-party acts as a communication hub to and from the manufacturer and between the manufacturer and to and from the FDA, which helps maintain objectivity in the program and legitimacy of the third party.
Under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, the FDA was required to set and publish criteria for third party review organizations to be accredited, reaccredited, and denied (re)accreditation. Years later, the FDA Reauthorization Act of 2017 (FDARA) was put into place requiring the FDA to inform the public as to what information it considers when deciding which device types would be eligible for review by a third party.
In 2019, with the outbreak of the pandemic SARS-CoV-2 (COVID-19) virus, the FDA was faced with a significant increase in its workload in many areas, most notably in vitro diagnostics. With it came a tidal wave of Emergency Use Authorization (EUA) requests from manufacturers looking to market detection devices for the virus. As the number of EUAs issued grew, the FDA focused its efforts on reviewing detection test with new intended uses, such as those for home use (e.g., over-the-counter), while it once again sought to contract with third party EUA review organizations (3PEUA RO) to assist in handling the EUAs for which the FDA felt confident in having had previous experience and a history of supporting information. From this was born, the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act) of 2022 outlining the FDA’s control over the third parties in conducting EUAs and the guidance required for the program.
Read more about the latest guidance of these programs here.
