Biomaterials and regulatory science

Abstract

• This article elucidates the relationship between biomaterials & regulatory science. • Regulatory authorities approve/clear final medical products, not biomaterials. • No definition/regulation on the so-called medical-grade or implantable materials. • Regulatory science helps to assess safety and efficacy of medical products. • Safety and efficacy refer to final medical products, not biomaterials alone. The fast development of both biomaterials and regulatory science calls for a convergence, which is addressed in this article via their link through medical products of biomaterials and related safety and efficacy evaluation. The updated definition of biomaterials, and concepts of biomaterials-related medical products and so-called medical-grade and implantable materials are firstly introduced. Then a brief overview of the concept and history of regulatory science and its assessment of safety and efficacy of medical products, as well as the currently ongoing biomaterials-related regulatory science programs are presented. Finally, the opportunities provided by regulatory science for biomaterials as well as challenges on how to develop a biomaterials-based regulatory science system are discussed. As the first article in the field to elucidate the relationship between biomaterials and regulatory science, key take-home messages include (1) biomaterials alone are not medical products; (2) regulatory authorities approve/clear final medical products, not biomaterials; (3) there is no definition/regulation on the so-called medical-grade or implantable materials; and (4) safety and efficacy refer to final medical products, not biomaterials alone.