On May 10, the U.S. FDA issued a draft guidance for industry and FDA staff concerning additive manufactured devices.For comment purposes only, this document welcomes comments and suggestions electronically until Aug 8. Written comments can be sent to the following address:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852.
FDA says to identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.
The agency says, “Due to its versatility, 3D printing [also known as additive manufacturing], has medical applications in medical devices, biologics and drugs.” As a result, the applications may be regulated by either FDA’s Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research or the Center for Drug Evaluation and Research.
