AABB FDA 510(k) Third-Party Review Service

Expedite FDA Clearance For Your Eligible Device

Let AABB help you expedite the FDA clearance process for your eligible medical device. As one of only seven FDA-approved third-party reviewers, AABB specializes in accelerating the clearance process for eligible devices, allowing you to bring your products to market swiftly and efficiently.

Don't let regulatory hurdles slow you down. Choose AABB's FDA 510(k) Third-Party Review service and accelerate your path to market approval today. Contact us to get started.

Does AABB Provide Review For Laboratory-Developed Tests (LDTs)?

The FDA final rule establishing a regulatory framework for laboratory-developed tests (LDTs) anticipates that half of LDTs subject to premarket review requirements will be reviewed under its 510(k) Third Party Review Program.

AABB will be providing additional information on our 510k review of LDTs soon. Additional information related to this rule is available on our website.

Debra BenAvram

“AABB is thrilled to offer this fast track to market success. Our FDA-approved third-party review ensures a streamlined process led by our expert staff, accelerating time to market and advancing innovation.”

-Debra S. BenAvram, FASAE, CAE
Chief Executive Officer, AABB

Why Choose AABB's Third-Party Review?

AABB will leverage the experience of expert staff with the FDA's endorsement to expedite the approval process – all while continuing to ensure a thorough review of the highest quality. This translates to a significantly expedited time frame for your eligible devices to reach the market, providing you with a distinct competitive advantage.

AABB assumes responsibility for ensuring that your submission is promptly reviewed and recommendation submitted to FDA, streamlining the regulatory pathway for your products in as little as 30 business days.

What Are Eligible Devices?

AABB is accredited to review the premarket submissions for more than 40 eligible device types regulated as hematology, pathology, microbiology, general hospital and clinical chemistry.

The full list of eligible device types that AABB is eligible to review is available on the FDA website.

Who Do We Work With?


AABB receives file from 510(k) submitter, FDA receives and reviews recommendation and documentation, FDA makes final decision, FDA informs AABB of final decision, AABB informs submitter

Confirm Eligibility For AABB Review

Reach out to AABB’s expert review team to confirm device eligibility or to ask any additional questions about the process.

Inquire Now

Or contact us via email at accreditation@aabb.org.

Need Additional Support For Your Product?

AABB Consultants can provide additional support on getting a product ready. AABB Consulting Services provides tailored consultations with experienced consultants to propel your company forward.

Whether you're seeking assistance with regulatory compliance, strategic growth planning or more, our consultants are ready to support your success.

Learn More About AABB Consulting Services