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.
About the Discussion Paper
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 key questions to facilitate public comment.
The FDA is seeking input on each of these topics and on 16 questions posed in the discussion paper.
Submitting Comments on the Discussion Paper
As part of its commitment to innovations in device design and functions, the FDA is sharing 3D Printing Medical Devices at the Point of Care for review and comment.
The FDA seeks further input from the medical device industry, manufacturers, health care providers, health care facilities, and other stakeholders to address these topics and questions to further explore appropriate regulatory approaches for PoC 3D printing of medical devices.
The FDA encourages stakeholders to provide comments under docket number FDA-2021-N-1272. The last day to submit comments is February 8, 2022.