The second draft guidance outlines FDA's interpretation of which types of software are no longer considered medical devices.
The Food and Drug Administration released three new guidance documents on Thursday with implications for the digital health industry, including one highly anticipated guideline on how the agency plans to regulate clinical decision support tools.
The agency claimed December 4 to be the world's first to provide a comprehensive technical framework to advise manufacturers creating medical products on 3D printers. For example, there are knee replacements and implants created to fit like a missing puzzle piece into a patient's skull for facial reconstruction.
Even medicine can be manufactured on a 3-D printer, and FDA has already approved a 3-D printed drug that is used to treat seizures and has a more porous matrix than the drug manufactured in the traditional way, enabling the drug to dissolve more quickly in the mouth to work faster, Gottlieb said.
Additionally, it said, "The FDA would like to bring to the attention of institutions dealing in medical devices that donation of medical devices are regulated by the FDA under the Public Health Act, 2012, Act 851".
The guidance, available here, is meant to advise device manufactures on the technical aspects of 3D printing, as well as what information they should include on submissions for developing 3D medical devices. "We are already seeing the beginning of this evolution as hospitals and academic centers use their own 3D printers to create innovative dental implants, replace knee joints, and [produce] experimental heart valves and bone implants for use in clinical studies. Further down the road, there is the potential for this same technology to eventually be used to develop replacement organs". "We're also helping to advance the field of regulatory science with state-of-the-art 3D printing facilities located on the FDA's campus". "FDA engineers in the Center for Devices and Radiological Health have been conducting research using their own 3D-printing facility to investigate the effect of design changes on the safety and performance of devices, and to determine how iterative changes alter the device's fit and functionality. This research also helps inform us, as regulators, to help us understand the policy framework needed to ensure the quality and safety of 3D printed products". It includes FDA's thinking on various approaches to 3D printing, including device design, testing of products for function and durability, and quality system requirements.
"These steps are part of our broader effort to help ensure our regulatory framework is properly matched to the unique attributes of the new technologies we're being asked to review", said Gottlieb.
The technical guidance is only meant to provide FDA's initial thoughts on the emerging technology, and Gottlieb said the agency's recommendations are likely to evolve as the technology does. The Center for Biologics Evaluation and Research has recently interacted with more than a half-dozen manufacturers who have expressed interest in using 3D printing in some capacity to produce their medical products.