October 23, 2020
The Center for Devices and Radiological Health (CDRH) has reaccredited AABB as a third-party review organization for select premarket notifications [510(k)s]. The reaccreditation allows AABB to review the premarket submissions for eligible device types regulated as hematology and pathology devices, microbiology devices and clinical chemistry devices.
AABB encourages device manufacturers whose devices require a 510(k) 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 of 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 may contact AABB to learn more about 510(k) review process.