7.42 Regulatory Affairs

Food and Drug Administration (FDA) uses a risk-based framework to determine the degree of regulation of medical devices. Biomaterials used in medical devices may impact regulatory classification and, consequently, the degree of FDA regulation. Selection of novel biomaterials, including bioabsorbables, as well as the use of novel technologies such as 3D printing, may also impact the extent of testing that is required to support FDA approval. Pathways for FDA approval and regulatory considerations for medical device manufacturers and biomaterial suppliers are reviewed.