FDA Provides Suggestions for Point-of-Care 3D Printing of Devices
(Thursday, January 20, 2022)
Several 3D printed devices may be printed at the clinic rather than printed at a traditional manufacturing facility and shipped. But 3D printing operations still need to comply with FDA’s QSR and GMP requirements. FDA released a Discussion Paper listing three scenarios for 3D printed devices with examples and tips for complying with FDA’s requirements when 3D printing a device at a point-of-care (POC). The three possible scenarios discussed in the FDA document are: (1) the company with FDA approval helps the POC set up a 3D printing operation and takes responsibility for the POC meeting FDA requirements, (2) The company with FDA approval sets up a 3D printing operation on or near the POC site, or (3) The POC sets up an independent 3D printing operation and assumes all regulatory responsibilities, effectively becoming a 3D printed device manufacturing facility. As one can envision, the first and second scenarios are relatively straight-forward as the original manufacturer is closely involved with the 3D printing operations and can assure continued compliance. However, the third scenario requires the POC facility to create a quality system similar to that at a traditional manufacturing facility. The Discussion Paper provides suggestions for all three scenarios with list of issues to address, potential challenges and suggested solutions. As would be expected, low to moderate risk devise are relatively easier to 3D print at the POC facilities. The FDA document poses several questions for open discussion with the stakeholders and expects to release a final report or guidance documents to share the policies developed based on the feedback received. Several companies with 3D printed FDA approved medical devices have been already working closely with providers such as physician offices, surgical centers, hospitals and other POC locations to facilitate wider use of their devices. The FDA document should be an essential read for those manufacturers, or anyone interested in understanding the challenges and opportunities with 3D printed devices.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC