FDA Expands 510(k) Third Party Review Program in Bid to Increase Device Access


Posted March 16, 2020

The Food and Drug Administration (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.

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.”

The final guidance describes the factors used to determine device type eligibility in the 3P510k Review Program. These factors include, but are not limited to, the following:

  • The risk classification for the device type or device type subset. The FDA classifies risk in part based on “whether general controls are sufficient to provide a reasonable assurance of the safety and effectiveness of the device or there is sufficient information to establish special controls to mitigate such risks and provide such assurance.”
  • Whether the device type/device type subset involves permanent implantation in the human body or is meant to sustain or support human life.
  • The degree to which review of the device type can be conducted without multifaceted, interdisciplinary expertise.
  • Whether postmarket data exist suggesting that the device type is the subject of safety signals.

Participation in the 3P510k Review Program is voluntary. Rather than using a 3P510k Review Organization, 510(k) submissions can be sent directly to the FDA for review.

The agency will host a webinar on April 16, 2020, during which additional information on the final guidance will be provided to device manufacturers, 3P510k Review Organizations, and other interested parties.