The U.S. Food & Drug Administration (FDA) recently issued a discussion paper to gather feedback that will inform future policies and guidance regarding 3D printing medical devices at the point of care.
Amidst COVID-19 supply chain shortages, health care facilities began working with 3D printer manufacturers to print medical devices, e.g., face shields, face mask holders, nasopharyngeal swabs, and ventilator parts from locally-available materials directly at the point of care. FDA is considering how health care facilities, who are not traditional medical device manufacturers, should be regulated when making 3D printed devices. The FDA’s primary concerns regarding 3D printed devices at the point of care include:
While the FDA has not proposed any guidance or policy yet, the discussion paper invites feedback on the following potential regulatory approaches for 3D printing medical devices at the point of care:
The FDA outlined three potential regulatory scenarios:
Scenario 1: The 3D printer manufacturer assumes the responsibilities of the FDA regulatory requirements and the health care facility assumes the role of the user.
Scenario 2: The health care facility develops a business relationship with a “Traditional Manufacturer” who would be located at or near the health care facility site and who would be responsible for FDA regulatory compliance.
Scenario 3: The health care facility assumes all Traditional Manufacturer responsibilities and is responsible for FDA regulatory compliance.
This discussion paper is a starting point for regulating 3D printed medical devices at the point of care, and FDA encourages stakeholders to submit comments under docket number FDA-2021-N-1272. The last day to submit comments is February 8, 2022.
Foley is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group with any questions.