WASHINGTON -- The FDA's recently issued draft guidance on 3D-printed medical devices does not answer one big question related to physician involvement with such devices, an expert said here.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The draft guidance, which was issued Tuesday by the agency's Center for Devices and Radiological Health and its Center for Biologics Evaluation and Research, outlines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."
Although the guidance may affect physician practice, it excludes doctors in a way, Jacobson said. "It says [the guidance] 'may apply' to point-of-care manufacturers -- where a physician 3D-prints a medical device at the hospital, or at his or her own office. The guidance says it may apply to them, but it doesn't say it does apply ... I take that as the FDA saying, 'We don't know what to do with them now and we're going to put them off on the side.'"
Jacobson said the guidance does touch on one issue that affects physicians and patients: device labeling. He explained that the way these devices are currently manufactured, "the patient will go to the physician, and the physician will do the [necessary] imaging -- x-rays, CT scans -- and document what the patient's anatomy is." The images are sent to the device maker who uses 3D printing to make a device that will match the patient's particular anatomy; the device is then shipped to the doctor, who meets with the patient and makes sure it fits properly.
"The draft guidance acknowledges that because of the process, there might be times when image might be taken and the device may not be manufactured until months later, and the patient's anatomy may change" -- for instance, the patient may gain or lose weight, which will affect how the device fits, Jacobson continued. Therefore, the guidance says "there should be an expiration date on it acknowledging the small window of time when the device should match the patient's anatomy."
This guidance is more of a "first step" in the additive manufacturing area for FDA, he said. "Probably we will see additional regulations come out that will focus on the unique nuances of 3D printing, such as point-of-care and bioprinting [printing cell and tissue substitutes using a 3D process]." There are also quality-control issues to think about, such as whether devices are being printed under sanitary conditions and whether the products are being evaluated for quality control.
Jacobson said the draft guidance seemed reasonable to him -- "it's really in line with regulations the medical device companies had anyway." The public will have 90 days to submit comments on the draft guidance before it's finalized, he noted.
So far, the FDA "has reportedly cleared no fewer than 85 medical devices made using 3D printing additive manufacturing processes," according to a white paper from Reed Smith issued in September 2015. (Jacobson contributed to the white paper, but not to this section of it.) However, the authors noted, all of those devices were cleared using the 510(k) approval process for lower-risk devices.
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