The American College of Radiology® (ACR®) submitted comments Feb. 7, to the U.S. Food and Drug Administration (FDA) addressing the agency’s discussion paper, 3D Printing Medical Devices at the Point of Care. Public feedback will inform the FDA’s future development of regulatory oversight approaches to 3D printed medical devices created within healthcare facilities (HCFs).
The ACR focused on scenarios involving lower risk 3D printed devices created by the same HCFs responsible for the medical use of the devices. The ACR recommends the FDA:
- Designate anatomic models created by end-user HCFs as very low risk.
- Exercise enforcement discretion with respect to very low-risk devices created by end-user HCFs.
- Discontinue use of the term point of care for describing 3D printing within HCFs.
ACR members with questions can contact Michael Peters, ACR Government Affairs Director.