FDA 510(k) Third-Party Review

AABB Can Help Speed Clearance for Eligible FDA 510(k) Devices

Expedite the 510k clearance process for eligible medical device(s) by submitting your 510k to AABB. AABB is approved by the FDA as a third-party reviewer to help expedite the device clearance process. The FDA’s 510(k) Third-Party Review Program offers a voluntary alternative review process, in which accredited third-party review organizations, such as AABB, are allowed to review certain low-to-moderate risk pre-market medical device submissions. AABB will submit the reviewed 510k submission with appropriate recommendation(s) to FDA for an expedited final decision.

Devices reviewed by AABB are on an accelerated timeline, both by AABB expert staff and by the FDA, which leads to a significantly reduced time to market for eligible devices. Visit the FDA website for additional information about the program and the current list of reviewers as well as list of eligible devices for which AABB is approved as a 3rd party reviewer.

Contact AABB to find out the steps and requirements of the 510(k) review process.

Contact AABB

What is the 510(k) Third-Party Review Program

The FDA initiated this voluntary alternative review process to provide more rapid 510(k) decisions for lower-risk devices and to allow the agency to focus its resources on higher-risk devices. Approximately half of the 510(k)s the FDA receives are eligible for this program. As an accredited 3P510k review organization, AABB is permitted to work directly with companies, facilitating FDA review and clearance.

The process allows manufacturers to submit 510(k) device premarket applications directly to AABB, and the sole payment is between the 510(k) submitter and AABB. The Association then reviews the submission and makes recommendations to the FDA. The Agency maintains oversight of the review process, granting the final approval. AABB then shares the decision with the applicant.

Learn more about the 510(k) Third-Party Review Program.

How AABB Can Help

AABB is accredited to review the premarket submissions for eligible device types regulated as hematology, pathology, microbiology, general hospital and clinical chemistry devices. The full list of eligible device types that AABB is eligible to review is available on the FDA website.

For more information on how AABB can help you get devices through the clearance process more quickly, contact AABB to find out the steps and requirements of the 510(k) review process.

AABB Consultants Can Provide Additional Support

Companies who are looking for support in getting a product to the 510(k) review process, or with questions related to product development and approval may benefit from working with AABB Consulting Services. Our team of expert consultants can provide tailored, specialized consultations and analyses to help optimize your company’s growth.