The U.S. Food and Drug Administration (FDA) announced the availability of its guidance entitled “Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff,” which was published in the Federal Register. This guidance was previously circulated in May 2016 in a draft form and underwent a comment period, where FDA was able to make minor modifications to the guidance based on those from the 3D printing industry. As 3D printing of medical devices continues to alter the daily practice of medicine, this “leapfrog guidance” is meant to provide FDA’s initial thoughts on technical considerations specific to medical devices using 3D printing. This guidance outlines technical considerations associated with the 3D printing processes as well as device design, testing of products for function and durability, and quality system requirements.
In releasing the final guidance, FDA Commissioner Dr. Scott Gottlieb, issued a statement proclaiming that the FDA “is the first [agency] in the world to provide a comprehensive technical framework to advise manufacturers creating medical products on 3D printers.” According to the FDA Commissioner, the agency has reviewed more than 100 medical devices and one drug that are currently on the market, which are being manufactured by 3D printers. He goes on to say that the “FDA is now preparing for a significant wave of new technologies” and that the FDA is “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.” That regulatory framework will need to adjust how “existing laws and regulations that govern device manufacturing [apply] to non-traditional manufacturers like medical facilities and academic institutions that create 3D-printed personalized devices for specific patients they are treating.” The FDA is also researching the technology itself and has its own 3D printing labs and is providing opportunities for “innovative approaches to pharmaceutical product design or manufacturing, including additive manufacturing of pharmaceuticals.” In fact, according to the statement “[m]ore than a dozen pharmaceutical manufacturers have formally or informally been in contact with [the FDA’s Center for Drug Evaluation and Research] regarding the use of 3D printing to manufacture drugs.”
While the guidance is not meant to be an all-inclusive document to address all regulatory or technical requirements, it highlights the technical considerations and recommendations for design, manufacturing, and testing of medical devices that are manufactured using 3D printing techniques. The guidance is also meant to evolve as the technology grows over time.
As with its draft version, the guidance is split up into two categories of considerations: (1) design and manufacturing, and (2) device testing. This final guidance should help 3D printing device companies, both traditional and non-traditional, as to what to include in a premarket submission for a device that uses additive manufacturing. As the technology continues to grow, we anticipate that the FDA will become more and more involved in the process.
For more about the draft FDA guidance, please see: FDA Publishes Draft Guidance Regarding 3D Printing Of Medical Devices and for more on general legal issues involving 3D printed medical devices, please see: 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles, 3D Printing of Manufactured Goods: An Updated Analysis, and 3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers.”