CDRH Industry: New 3D Printing Web Content and Technical Considerations for Additive Manufactured (3D Printed) Devices Draft Guidance

The FDA has posted new web content describing how 3D printing is used to create medical devices and the Center for Devices and Radiological Health’s role in regulating 3D printed medical devices.  The new web content will include information about the Technical Considerations for Additive Manufactured Devices Draft Guidance which published on Tuesday, May 10th.

The FDA published this guidance to seek feedback on recommendations for device design, manufacturing, and testing considerations when developing devices through 3D printing techniques. The guidance does not address how the FDA regulates 3D printed devices. The FDA is currently evaluating submissions for new 3D printed medical devices to determine safety and effectiveness.

Comments can be submitted to the docket until August 8, 2016.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health