Rob Allen

Regulatory Affairs – Biocompatibility at MCRA

Speaker

Dr. Allen is a former FDA medical device reviewer with 8 years of experience in regulatory affairs. Dr. Allen is a biocompatibility expert with extensive experience in biological evaluation including biological risk assessment, biological testing, hemocompatibility evaluation, and manufacturing-based rationales. As a biocompatibility consultant, Dr. Allen helps clients to develop and execute efficient biocompatibility evaluation strategies that avoid unnecessary testing. Dr. Allen is also active in the international biocompatibility community, providing biocompatibility regulatory recommendations to a global audience.

Prior to MCRA, Dr. Allen spent 3 years at FDA in the Center for Devices and Radiological Health (CDRH). Dr. Allen’s work at CDRH included lead review and biocompatibility review in the Division of Cardiovascular Devices (now known as OHT2). Dr. Allen led the review of cardiovascular devices including embolization devices, vascular grafts, and arteriovenous access products. Dr. Allen also represented the FDA’s view on biocompatibility evaluation at cardiovascular device conferences. Prior to serving as a lead reviewer, Dr. Allen served as an AIMBE Scholar at FDA, focusing on strategic projects for the Office of Device Evaluation (now known as OPEQ), including device reclassifications from class III to class II.

Dr. Allen received his B.S. and Ph.D. from the University of Pittsburgh in bioengineering, where he researched the application of absorbable polymers in synthetic vascular graft designs. Dr. Allen also served as an award-winning community leader in Pittsburgh’s biomedical innovation ecosystem.