The U.S. Food and Drug Administration (FDA) through its Center for Devices and Radiological Health (CDRH) has released a significant discussion paper focusing on 3D Printing Medical Devices at the Point Of Care. This initiative signals the FDA’s proactive approach to understanding and regulating the evolving landscape of medical device manufacturing in healthcare settings.
Download the Discussion Paper PDF (8.2 MB)
Understanding the 3D Printing at Point of Care Discussion Paper
This discussion paper serves as a foundational document, offering background information on 3D printing and proposing various potential Point of Care (PoC) manufacturing scenarios. Crucially, it is not a guidance document but rather a platform to solicit public feedback. The FDA aims to leverage this feedback to shape future policy development concerning point of care 3D printing in medicine.
The paper delves into several key areas:
- Background and Terminology: It establishes a common understanding by defining terms, outlining the FDA’s existing regulatory framework for medical devices and 3D printing, and examining how the capabilities of a point of care 3D printing facility impact device safety and efficacy.
- Challenges and Regulatory Approaches: The paper identifies specific challenges associated with 3D printed medical devices manufactured at the point of care. It further proposes potential regulatory oversight strategies for diverse scenarios, intending to inform the development of future policies in this area.
- Key Questions for Stakeholders: To facilitate constructive public input, the discussion paper poses 16 key questions, prompting stakeholders to share their insights and perspectives on point of care 3D printing of medical devices.
Call for Public Comments on Point of Care 3D Printing
Reflecting its commitment to fostering innovation in medical device design and functionality, the FDA is actively seeking review and comments on this discussion paper, titled 3D Printing Medical Devices at the Point of Care.
The FDA is particularly interested in gathering input from a wide range of stakeholders. This includes the medical device industry, device manufacturers, healthcare providers, healthcare facilities, and other relevant parties. Their feedback is vital to comprehensively address the topics and questions raised in the paper and to collaboratively determine appropriate regulatory paths for PoC 3D printing of medical devices.
Stakeholders are encouraged to submit their comments under docket number FDA-2021-N-1272 through the regulations.gov portal. The deadline for submitting comments is February 8, 2022.
