FDA requests feedback on 3D printing of medical devices at the point of care
AI in Healthcare December 13, 2021
The FDA has published a new discussion paper focused on regulating 3D-printed medical devices manufactured at the point of care.
The agency’s Center for Devices and Radiological Health (CDRH) shared the document on Dec. 10, requesting feedback from “the medical device industry, manufacturers, healthcare providers, healthcare facilities and other stakeholders.”
“The 3D printing of medical devices is at the forefront of innovation and healthcare,” William Maisel, MD, director of the CDRH’s Office or Product Evaluation and Quality, and Ed Margerrison, PhD, director of the Office of Science and Engineering Laboratories, said in a prepared statement. “3D printing at hospitals and other patient-care settings enables health care professionals to quickly create patient-matched devices and anatomical models for surgical planning, as well...