The FDA has released final guidance on 3-D printed medical devices, giving developers concrete steps for getting products approved.
The guidance released Monday makes clear the process for creating safe products. That could spur innovation in the industry, according to Dean Carson, vice president of U.S. operations for Anatomics, a medical-device manufacturer.
"They're trying to create a pathway that people can walk along in order to create high quality implants that meet all the standards," he said.
Developers might be able to bring their 3-D printed devices to market more efficiently, said Jim Shehan, chair of Lowenstein Sandler's FDA regulatory practice. He said the move was a continuation of FDA's shift to adopt procedures that will help get products to the market faster, something FDA Commissioner Dr. Scott Gottlieb has vowed to do.
"If you're sitting there and you have the idea to get one of these products approved, you want clarity as to what you need to out into an application," Shehan said.
This guidance outlines what the FDA wants for device design and testing as well as quality system requirements for 3-D printed devices—which the FDA calls additive manufacturing.
Some of the guidance focuses specifically on "patient-matched devices"—those that are designed to fit specific patients, based on clinical information. This clinical information can come from patient measurements, clinical assessments, imaging or a combination of those techniques. The FDA points out that engineers will need to create some devices to be able to change over time, as a patient's anatomy changes.
"The access to patient-matched devices will be enhanced greatly by the FDA's acceptance of this new technology," Carson said, though he pointed out that the technology isn't as new as many people think.
The guidance does not cover all considerations related to 3-D printing. It does not, for instance, address unconventional manufacturing facilities, such as hospitals and university labs, said Andrew Rebhan, senior analyst for research at the Advisory Board. Nor does it address bio-printing (printing tissues and organs). That technology, Rebhan said, "holds great potential for health systems, so the fact that this guidance doesn't cover it means we will have to wait for future releases from the FDA."
Overall, the guidance is important for the industry, Carson said.
"You've got two ends of the spectrum: the companies trying to create the products that are going to advance healthcare and then FDA trying to ensure those products are as safe as possible," Carson said. "A guidance document like this is bridging the gap."
