USA – FDA rolls out plan to reduce third party 510(k) re-reviews

Dive Brief:

  • Responding to a mandate in the FDA Reauthorization Act of 2017 (FDARA), the agency Thursday released draft guidance delineating how the agency decides if certain medical devices are eligible for review under the 510(k) Third Party Review Program.
  • Simultaneously, FDA released a plan to cut down on the number of 510(k) submissions the agency has to re-review that a Third Party Review Organization has already reviewed. FDA says that it aims to have 85% of these third party submissions not be required for re-review by the end of fiscal year 2021.
  • Commissioner Scott Gottlieb said outsourcing review of lower-risk devices can enable FDA to focus more resources on higher-risk and more complex devices.

Dive Insight:

The Third Party Review Program (3PRO), formally known as the Accredited Persons Program, allows 510(k) submissions for certain low-to-moderate risk devices to be submitted to a third party instead of the FDA. After the outside party recommends a determination of substantially equivalent or not substantially equivalent, FDA then makes a final call on the 510(k) submission.

To cut down on the number of re-reviews, FDA says that it is utilizing new authority in FDARA that allows the agency to tailor which devices are eligible for third party review. The new draft guide lays out the factors FDA will use when looking at choosing which devices are eligible for review by outside organizations « including whether the device type is implantable, life sustaining, life supporting, and well understood. »…