FDA Seeks Public Input on 3D Printing Medical Devices at the POC

The U.S. Food and Drug Administration (FDA) published a discussion paper about 3D printing medical devices at the point of care (POC), for example in hospitals and clinics. The paper, according to FDA, isn’t guidance but rather to get public feedback to inform policy development.
 
The paper includes relevant background, terminology, a brief overview of device and 3D printing regulation, and 3D printing facility capabilities affect device safety and effectiveness. It also points out challenges of POC 3D printed medical devices and offers possible approaches for regulatory oversight under a number of scenarios. It additionally poses questions for public comment.
 
“The 3D printing of medical devices is at the forefront of innovation and healthcare,” CDRH’s William Maisel, M.D.,M.P.H., director of the Office of Product Evaluation and Quality and Ed Margerrison, Ph.D., director of the Office of Science and Engineering Laboratories commented in an FDA press release. “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 as many other uses that can help health care facilities rapidly respond to patient needs. The discussion paper we’re sharing today provides insight into our perspective of the benefits and challenges of 3D printing at hospitals and other points of care and presents a potential approach for regulatory oversight under various scenarios to inform future policy development. Importantly, the release of this discussion paper is intended to foster discussion and solicit feedback from the public. This feedback 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.”
 
The discussion paper is open for public comments for 60 days here.