The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued a discussion paper, 3D Printing Medical Devices at the Point of Care.
The discussion paper provides background information on 3D printing and proposes potential PoC manufacturing scenarios for public comment. The discussion paper does not constitute guidance; instead, its purpose is to gather feedback from the public to inform future policy development.
The discussion paper:
- Considers relevant background, including terminology, the FDA regulation of devices and 3D printing, and how capabilities at a 3D printing facility factor into device safety and effectiveness
- Identifies challenges presented by 3D printed medical devices at PoC and presents a potential approach for regulatory oversight under various scenarios to inform future policy development
- Poses questions to facilitate public comment