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Medical Device Regulations and Testing for Toxicologic Pathologists

From Applied Veterinary Pathobiology PLLC, Bainbridge Island, Washington, USA

Correspondence: Address correspondence to: JoAnn C. L. Schuh, Applied Veterinary Pathobiology PLLC, 1752 Lewis Place NW, Bainbridge Island, WA 98110-3663; e-mail: Schuhj{at}bainbridge.net.

Awareness of the regulatory environment is fundamental to understanding the biological assessment of biomaterials and medical devices. Medical devices are a diverse and heterogenous group of medical products and technologies defined by the lack of chemical action or requirement for metabolism. Regional activity and the Global Harmonization Task Force are now working on harmonizing the categorization and testing of medical devices. The International Organization for Standardization (ISO) has published 19 standards for biological evaluation. ISO 10993 standards are generally accepted outright or as an alternative to most national regulatory directives or acts, although Japan and the United States require more stringency in some tests. Type of materials, intended use, and risk are the basis for drafting testing programs for biomaterials and medical devices. With growth of the medical device industry and advent of new biomaterials and technologies, the need for toxicologic pathologists in safety (biocompatibility) and efficacy (conditions of use) evaluation of moderate- to high-risk devices is expanding. Preclinical evaluation of biomaterials and medical devices increasingly requires a basic understanding of materials science and bioengineering to facilitate interpretation of complex interface reactions between biomaterials, cellular and secretory factors, and vascular and tissue responses that modulate success or failure of medical devices.

Key Words: Biocompatibility testing • ISO 10993 • Global Harmonization Task Force • medical device • preclinical • device safety • biomaterials • immunotoxicology

Abbreviations: AIMD, active implantable medical device • AIMDD, AIMD directive • CDRH, Center for Devices and Radiation Health • DHP, drugs and health products • EU, European Union • FDA, Food and Drug Administration • GHTF, Global Harmonization Task Force • GCP, good clinical practice • GLP, good laboratory practice • GMP, good manufacturing practice • ICH, International Conference of Harmonization • ISO, International Organization for Standardization • IVDD, in vitro device directive • MDD, medical devices directive • PMA, premarketing approval • PMDA, Pharmaceutical and Medical Device Agency • TGA, Therapeutic Goods Act • USP, U.S. Pharmacopeia

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