Reflecting increased interest in 3D printed medical devices—boosted as a result of the pandemic—the U.S. FDA developed a discussion paper on how the devices would be regulated at point of care (PoC).
While not a draft or final guidance, the discussion paper from December 2021 is a step toward exploring how FDA could oversee 3D printing of medical devices that fall under the purview of the Center for Devices and Radiological Health. The implementation of 3D printing could help healthcare facilities (HCF) develop rapid personal care solutions for patients in need of medical devices and would also allow for the quick manufacturing of 3D-printed devices near where the patient is being seen, the FDA said.
“FDA recognizes that 3D printing at the PoC contributes to the development of new device designs, clinical solutions, and enhanced approaches to rare and complex cases (e.g., invasive tumor resection, congenital heart defects). As 3D printing brings more product development opportunities to the PoC, FDA intends to continue facilitating innovation in a manner that still provides a reasonable assurance of device safety and effectiveness,” the agency wrote in the discussion paper.
Read the full article at the Regulatory Affairs Professionals Society.
