FDA has issued final guidance on its 510(k) Third Party Review Program, as well as updated the list of devices that are eligible for review under the program, according to a statement from the AAMI.
Increased use of the 510(k) Third Party, or 3P510k, Review Program will allow for expedited “patient access to certain low-to-moderate risk and less complex devices, without changing our statutory or data requirements, by reducing agency review times to 30 days or less,” said the agency.
Under the 3P510k Review Program, which is formally known as the Accredited Persons Program, the FDA can designate “third parties to review premarket notification (510(k)) submissions and recommend the initial classification of certain devices,” wrote FDA in the final guidance. Several third parties are accredited to review 510(k) submissions currently.
The 3P510k Review Program was expanded by the FDA “to permit Accredited Persons to review many Class II devices that were not previously eligible.” Subject to certain conditions, the expanded program allows “Accredited Persons to review Class II devices for which there are no device-specific guidance documents.”
Read more from the AAMI.
