title: Regulatory biocompatibility requirements for biomaterials used in regenerative medicine.
abstract: The biological safety of biomaterials used for implantable medical devices is usually determined by a series of standard tests that assess the effects that extractable substances have on cells in vitro and in simple short term animal studies. To use these tests to determine the suitability of materials for tissue engineering templates is inappropriate. This short essay discusses the issues that are involved.
authors: Wake Forest Institute of Regenerative Medicine, Winston-Salem, NC, 27157, USA, dfwillia@wakehealth.edu.
authors: David F
authors: DF
authors: Williams
mesh_terms: D000818:Animals; D001672:Biocompatible Materials / Q000592:standards*; D006801:Humans; D007390:International Agencies / Q000331:legislation & jurisprudence / Q000592:standards; D019736:Prostheses and Implants / Q000592:standards*; D044968:Regenerative Medicine / Q000331:legislation & jurisprudence / Q000592:standards*; D023822:Tissue Engineering / Q000331:legislation & jurisprudence / Q000592:standards
chemical_list: D001672:Biocompatible Materials
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