Medical device materials are an important determinant of the “biocompatibility” (biological safety) of a medical device. However, the US FDA and EU Notified Bodies consider biocompatibility to involve more than just the device materials.
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This presentation explains how US and EU regulators review biocompatibility and provides insight on how to meet their expectations.
What we will cover:
- Importance of biocompatibility for regulatory success
- Definition and core principles of biocompatibility
- FDA and EU approaches to biocompatibility review
- Strategies for well-characterized materials vs. new medical device materials
Expert Speaker
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Rob Allen, Ph.D., Senior Associate, Regulatory Affairs, MCRA
Dr. Allen is a former FDA medical device reviewer with 5 years of experience in regulatory affairs, including US and international regulatory submissions. Dr. Allen is also a biocompatibility expert with extensive experience in biological testing, hemocompatibility evaluation, chemical characterization, toxicological risk assessment, and risk-based rationales. Dr. Allen has worked on a wide range of device types including cardiovascular, orthopedic, and plastic/reconstructive surgery devices.At MCRA, Dr. Allen 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.
Dr. Allen also serves in lead and/or support roles on 510(k), Pre-Submission, Investigational Device Exemption (IDE), Premarket Approval (PMA), and Clinical Evaluation Report (CER) submissions for MCRA’s medical device clients.
