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FDA to provide guidance to manufacturers of 3D-printed medical devices
FDA announced it is working to create a technical framework for manufacturers that develop medical products using 3-D printers.
“We’re working to provide a more comprehensive regulatory pathway that keeps pace with those advances, and helps facilitate efficient access to safe and effective innovations that are based on these technologies,” FDA Commissioner, Scott Gottlieb, MD, said in an FDA statement.
In his statement, Gottlieb said the FDA is issuing guidance for device manufacturers to provide advice on technical aspects of 3-D printing to clarify what the FDA recommends on submissions for 3D-printed medical devices. The guidance includes the FDA’s thoughts on device design, testing of products for function and durability, and quality system requirements.
The FDA has reviewed more than 100 devices manufactured on 3-D printers. Among the devices that were reviewed are patient-matched devices, such as personalized knee replacements and implants for facial reconstruction.
“We are already seeing the beginning of this evolution as hospitals and academic centers use their own 3-D printers to create innovative dental implants, replacement knee joints, and experimental heart valves and bone implants for use in clinical studies,” Gottlieb said.
He added, “In order to help ensure the safety and effectiveness of these products, we’re working to establish a regulatory framework for how we plan to apply existing laws and regulations that govern device manufacturing to non-traditional manufacturers like medical facilities and academic institutions that create 3D-printed personalized devices for specific patients they are treating. Developing a transparent policy on 3-D printing remains an important next step for us, and we plan to explore the role of nontraditional manufacturing facilities like a hospital operating room or university laboratory.”
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This piece outlines a framework of potential regulation for medical devices that employ additive manufacturing (AM) technologies in their production. It is the end product of a 2014 workshop whose attendees included medical device manufacturers, AM companies and academia. See this link for details: http://bit.ly/2kPaFBJ.
The guidance piece is loosely organized into two categories: 1) design and manufacturing considerations; and 2) testing considerations. The authors emphasize that it is preliminary in nature and will evolve with time. The piece’s main emphasis then is to highlight some of the unique risks and subtleties inherent to AM in medical devices and to inform stakeholders of the technical considerations that the FDA will consider as regulations become more specific.
The guidance is broad in scope, but at multiple points it states that it is not comprehensive and should not substitute for adequate quality system (QS) assurances. In general, devices manufactured with AM will need to comply with any previously established regulation in addition to future AM-specific guidelines. Three-dimensional printing is a highly software-intensive process. From design to manufacture, multiple different software programs may be implemented to complete a build. Development and maintenance of standards for each software program will be a targeted area of regulation in the future. We are entering a new era in which relatively opaque software algorithms will play a larger role in the medical device space. While it offers significant potential for new innovation, it creates substantial new complexities and uncertainties that will be difficult to anticipate.
The piece does not provide any guidance about biological tissues created with 3-D printing.