AABB Approved to Review 510(k) Submission for Additional Devices

The Center for Devices and Radiological Health (CDRH) has expanded the number of devices for which AABB is accredited to review the premarket submissions [510(k)s]. AABB is now accredited to review the premarket submissions for eligible device types regulated as hematology and pathology devices, microbiology devices, general hospital devices and clinical chemistry devices.

AABB encourages device manufacturers whose devices require a 510(k) submission to FDA for review to contract directly with AABB for the primary review. AABB will then forward the review, recommendation and the 510(k) directly to the Food and Drug Administration. By law, FDA must issue a final determination within 30 days after receiving the recommendation from AABB.

The full list of device types that AABB is eligible to review is available on the FDA website. AABB’s recognition will remain valid until Oct. 15, 2023. Individuals interested in third-party review should contact AABB to learn more about 510(k) review process.