The FDA is already looking closely at 3D printing. Last September, Jeffery Shuren, director of FDA’s Center for Devices and Radiological Health, speaking during an industry conference, told the audience that the agency would issue guidance on 3D printing in “less than two years.”
It appears the impending two-day workshop, scheduled for October, will inform much of that guidance. “Ideas generated during this workshop may facilitate development of new draft guidances and/or standards for additive manufacturing of medical devices,” says the agency’s notice in the Federal Register.
The regulatory hurdles are many. Will the FDA decide to regulate the 3D printer itself or just the end product? Would the devices be required to be registered with the FDA? Design files are freely shared; would they have to carry notice of potential risk? Are products printed by unlicensed FDA printers considered rogue medical devices?
And it’s not just hardware that the FDA has to contend with; many medical advances using 3D printing deal with tissue. NASA is exploring how it can use 3D printing to manufacture personalized medicine for astronauts during long space missions.
The workshop will serve as a forum for all concerned stakeholders, the agency said in the Federal Register: “The purpose of this workshop is to provide a forum for FDA, medical device manufacturers, additive manufacturing companies, and academia to discuss technical challenges and solutions of 3-D printing. The Agency would like input regarding technical assessments that should be considered for additively manufactured devices to provide a transparent evaluation process for future submissions.”
The agency acknowledges the technology is rapidly advancing. “FDA has begun to receive submissions using additive manufacturing for both traditional and patient-matched devices, and we see many more on the horizon. Industry forecasts project significant growth of additive manufacturing in both traditional and innovative environments by 2025,” the notice says.
The FDA notes what it calls “technical challenges” of 3D printing related to the entire manufacturing cycle “from design to final product that need to be properly addressed in all cases to ensure patient safety and promote innovation in a fast-moving field.” The notice says “process verification and validation are especially important when devices are produced individually or in very small batches.”
The agency aims to keep the workshop as top-level as possible, addressing “scientific and technical challenges” but not “specific printing technologies or medical devices.” The latter, the agency says, “will still be covered by their respective standards and guidance documents.”