The U.S. Food and Drug Administration (FDA) has released a discussion paper on the use of so-called 3D printing technology in the production of medical devices in hospitals and doctors’ offices.
The paper, “3D Printing Medical Devices at the Point of Care (PoC),” provides extensive background on the FDA’s current regulation of devices and 3D printing technologies, as well as key challenges to device safety and effectiveness presented by the use of such technologies. The paper also poses 16 different questions on the 3D printing of medical devices to garner input from the medical device industry, healthcare facilities and providers, and other stakeholders.
The FDA says that stakeholder input will “help build the foundation for an appropriate regulatory approach for 3D printing at the point of care, personalized care for patients and new innovations in this area.”
Comments on the discussion paper can be filed through the Regulations.gov website through February 8, 2022 (reference Docket FDA-2021-N-1272).