FDA Releases New "Leap-Frog" Guidance on 3D Printing of Medical Products
Including Innovative Drug Delivery Solutions
[From www.fda.gov] Today we are issuing new guidance to help advise device manufacturers on technical aspects of 3D printing, referred to as additive manufacturing, that clarifies what the FDA recommends manufacturers include on submissions for 3D-printed medical devices. It includes our thinking on various approaches to 3D printing, including device design, testing of products for function and durability, and quality system requirements. Overall, it will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and making sure our regulatory approach is properly tailored to the unique opportunities and challenges posed by this promising new technology.
But this technical guidance -- categorized as a "leap-frog" guidance because it helps bridge where we are today with innovations of tomorrow -- is only intended to provide the FDA's initial thoughts on an emerging technology with the understanding that our recommendations are likely to evolve as the technology develops in unexpected ways.
Janet Woodcock's Insights:
[From The Readout by STAT] With 3-D printing, the drug industry is "going to be only bounded by imagination" in how to design pharmaceutical products, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said on December 5, 2017, at the FDA/CMS Summit in D.C.
"You can imagine printing a drug on a film and so then you can sort of cut pieces of film [to decide] how much dosing you want, or tear it off like candy that comes in little squares," Woodcock said. Woodcock also said that drugs could be printed on top of devices -- perhaps an implantable device coated with a therapeutic film.