The FDA has approved AABB to conduct the primary review for eligible devices as a third-party reviewer for the FDA 510(k) process which is used for most medical devices to receive marketing clearance in the United States.
If a 510(k) is required for your device, you may elect to contract directly with AABB for the primary review. AABB will then forward the review, recommendation and the 510(k) directly to the FDA. By law, the FDA must issue a final determination within 30 days after receiving the recommendation from AABB.
Verify that your device is eligible for review online.
For more information,
contact AABB to find out the steps and requirements of the 510(k) review process.
September 13, 2021
September 07, 2021
August 31, 2021