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.
A December 4 statement from FDA Commissioner Dr. Scott Gottlieb said that "3D printing of medical devices, medications, and human tissue is quickly becoming a promising reality".
"We recognize that our regulations play a crucial role in the efficient development of such technologies", Gottlieb wrote in a statement.
The FDA released a slew of policy documents Thursday pertaining to development of digital health tools, meant to clarify which are subject to regulatory oversight and which aren't. According to the guidance, analytics technology meant to support clinical diagnoses that provides room for a physician to independently review the basis of the software's recommendations would not be regulated by the FDA. "We must always lean in the direction of enhancing access to more information-not restricting information flow-given the ability of reliable information to positively impact daily life".
The first draft guidance addresses clinical decision support (CDS) tools, outlining what technologies would and would not fall under FDA oversight.
The guidance also proposes not to regulate lower-risk digital health tools intended for use by patients or caregivers, such as apps that remind patients when to take a drug.
If CDS technology provides recommendations based on "analytical functionalities", like a diagnosis based on spinal fluid analysis, it will still qualify as a medical device.
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.
Examples of SaMD include software meant to diagnose a condition using an accelerometer in a digital camera, that allows MRI and other types of medical imaging to be viewed on regular mobile devices, that performs image processing to detect cancer, and that regulates an installed medical device like a pacemaker. Drafted in October 2016, the final guidance expands on that draft and establishes common principles for regulators to use in evaluating the safety, effectiveness and performance of Software as a Medical Device (SaMD). Gottlieb intends the guidance to offer some clarity, including about which kinds of clinical decision support tools would not be classified as medical devices and therefore would not be subject to FDA regulation.
The US Food and Drug Administration (FDA) on Thursday unveiled three guidance documents - two draft and one final - that clarify which types of software will be regulated. Gottlieb wrote that the final guidance includes input from the FDA's worldwide counterparts to outline "globally recognized principles for analyzing and assessing SaMD, based on the overall risk of the product". "Through this comprehensive approach, we can deliver on our commitment of promoting beneficial innovation in this space while providing proper oversight where it's merited", Gottlieb said in a statement.