Robert Allen

Robert Allen, Ph.D.

Director, Regulatory Affairs - Biocompatibility

Dr. Allen is a former FDA medical device reviewer with 5 years of experience in regulatory affairs. Dr. Allen has worked on a wide range of device types including cardiovascular, orthopedic, and plastic/reconstructive surgery devices. Dr. Allen is also a biocompatibility expert with extensive experience in biological evaluation including biological risk assessment, biological testing, hemocompatibility evaluation, chemical characterization, toxicological risk assessment, manufacturing-based rationales


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.


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 2 years as a lead reviewer and biocompatibility reviewer 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.[3] 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.


[3] Allen, RA. Update on Biocompatibility. Podium Presentation. Greenberg Stent Summit, 2018. 


At MCRA, Dr. Allen develops and executes regulatory strategies for medical product clients. His work includes 510(k), Pre-Submission, Investigational Device Exemption (IDE), Premarket Approval (PMA), and Clinical Evaluation Report (CER) submissions for MCRA’s medical product clients. Dr. Allen also leads biocompatibility-based engagements, helping 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.[1],[2]

[1] Allen, RA. Medical Device Materials: The US and EU Biocompatibility Regulatory Landscape. August 6, 2020. LSX Webinar Series. Link.

[2] Allen, RA. Conducting Chemical Characterization/Risk Assessment for FDA Submissions. May 20, 2020. Orthopedic Design and Technology (ODT) Magazine. Link

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