The FDA touted the potential of 3D-printed medical devices and drugs Thursday, releasing regulatory science research on devices already cleared and approved by the agency. The FDA issued draft guidance on 3D-printed devices in May, which is currently open for comment until Aug. 8.
James Coburn, a senior research engineer for the FDA’s Center for Devices and Radiological Health, highlighted the potential for advancements in personalized medicine through 3D printing, also called additive manufacturing.
“With patient-specific devices, there are a lot of areas where people have been thinking about doing this, but it’s been cost prohibitive or technologically prohibitive, and 3D printing has opened up a lot of those doors,” Coburn said.
The FDA has already cleared 85 medical devices and one prescription drug manufactured via 3D printing. The devices, including orthopedic implants and surgical instruments, were approved through the agency’s current oversight of medical devices and drugs.
The FDA calls the guidance its “initial thoughts” on best practices for manufacturing, designing or testing 3D-printed devices, but officials note the rules stop short of addressing products that involve biological material.
“Most of the specifications right now are on the basic materials, bio formats, descriptive terms,” Coburn said. “We’re trying to bring knowledge of FDA best practices, knowledge of our regulatory requirements to the additive manufacturing standard so we can help foster industry growth, by letting them know what they need to do, letting them have clarity in things like testing methods.”
The guidance has only three public comments.
“This only gets better with outside expertise,” Coburn said.