by Joyce Frieden, News Editor, MedPage Today
WASHINGTON — The FDA’s recently issued draft guidance on 3D-printed medical devices does not answer one big question related to physician involvement with such devices, an expert said here.
“One of the biggest unknowns is whether a physician who 3D-prints a med device in the hospital or his or her own office would be considered a manufacturer for tort liability purposes,” said Matt Jacobson, JD, of the Reed Smith law firm. “No one knows what the answer is going to be.”
The draft guidance, which was issued Tuesday by the agency’s Center for Devices and Radiological Health and its Center for Biologics Evaluation and Research, outlines recommendations for design, manufacturing, and testing of 3D-printed devices, which the FDA refers to as “additive manufactured” devices because of their use of additive layers of materials.
The FDA emphasized that this guidance is a “leap-frog guidance.” “Leap-frog guidances are intended to serve as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development,” the agency wrote. “This leap-frog guidance represents the Agency’s initial thinking, and our recommendations may change as more information becomes available.”