Health Canada is developing a guidance to facilitate the licensing of 3D-printed medical devices, according to a report from the U.S. Food and Drug Administration (FDA).
Healthcare institutions have shown increasing interest in producing and distributing 3D-printed implants, the agency noted. The forthcoming draft guidance will center on premarket class III and class IV 3D-printed implants and provide instruction on how to make sure they meet ISO 13485 regulatory requirements.
