The FDA issued draft guidance on 3D-printed medical devices in May. The agency is accepting comments on the guidance until Aug. 8.
James Coburn, the principal investigator for the FDA’s Center for Devices and Radiological Health, described the potential 3D-printing could lend to personalized medicine.
“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,” said Mr. Coburn, according to The Hill.
So far, the FDA has cleared 85 medical devices and one prescription drug manufactured by 3D printing, such as orthopedic implants and surgical implants.
The FDA has dubbed the guidance its “initial thoughts” on best practices for designing, manufacturing and testing 3D-printed devices, though officials note the guidance does not address products that involve biological material, according to the report.
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