FDA releases draft guidance for 3D printed device manufacturing and testing
The US FDA has released a draft guidance publication for best practice for manufacturing, designing or testing 3D printed devices, which is open for comment until 8 August 2016.
The US FDA has highlighted the potential of 3D printing in the field of personalized medicine and announced the availability of draft guidance, providing the FDA’s initial thoughts on technical considerations specific to devices made with additive manufacturing. The guidance is open for comments until 8 August 2016.
The draft guidance, entitled ‘Technical Considerations for Additive Manufactured Devices’, outlines technical considerations associated with additive manufacturing processes, as well as with the testing and characterization of final 3D printed devices.
James Coburn, senior research engineer at the FDA’s Center for Devices and Radiological Health, highlighted the potential that 3D printing holds in the field of personalized medicine: “With patient-specific devices, there are a lot of areas where people have been thinking about doing [personalized medicine], but it’s been cost prohibitive or technologically prohibitive, and 3D printing has opened up a lot of those doors.”
At present, the FDA has approved 85 3D printed medical devices, plus a 3D printed prescription drug. The new guidelines are applicable to 3D printed devices and drugs, but do not address bioprinting and the inclusion of biological products.
“Most of the specifications right now are on the basic materials, bio formats, descriptive terms,” Coburn explained. “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.”