Discussion Paper on 3D-Printed Device Oversight

CDRH has issued a discussion paper, “3D Printing Medical Devices at the Point of Care,” that proposes potential point-of-care (PoC) manufacturing scenarios for public comment. The paper identifies challenges presented by 3D-printed devices at PoC and offers a potential approach for regulatory oversight under various scenarios to inform future policy development. It says that a healthcare facility should “ensure that any medical devices 3D printed at the PoC will be high-quality, perform as intended, and will not expose patients to unreasonable risk of illness or injury.”

FDA’s paper provides an initial outline for a regulatory approach for devices manufactured using 3D printing at the PoC. It provides the agency’s initial thoughts for early public input on potential PoC manufacturing scenarios prior to proposing draft guidance for 3D printing of medical devices at the PoC.

FDA expects to issue draft guidance on the topic after considering public comment on the discussion paper.