Fda Guidance 3d Printing Medical Devices

On december 4 2017 the fda issued first of its kind.

Fda guidance 3d printing medical devices.

The fda is issuing final guidance on the technical considerations for the 3d printing of medical devices. By doing so submissions for 3d printed products can be expedited in the fda approval process. Why 3d printing matters from an fda standpoint. Food and drug administration fda is preparing for a wave of new technologies that are nearly certain to transform medical practice said fda commissioner scott gottlieb md in a statement announcing the final guidance for 3d printed medical devices.

3d printed left to right top models of a brain blood vessel surgical guide and bottom medallion printed on fda 3d printers. Today we are issuing new guidance to help advise device manufacturers on technical aspects of 3d printing that clarifies what the fda recommends manufacturers include on submissions for 3d printed medical devices states fda commissioner scott gottlieb m d. These steps are part of. Now that the 3d printing of medical devices has become a promising reality the u.

Medical devices produced by 3d printing include orthopedic and. This guidance outlines the fda s recommendations for 3d printed devices from the. Some of the potential ramifications of hospitals and other medical providers becoming medical device manufacturers by using 3d printing on site. Health canada a department of the canadian government has issued new guidance for the 3d printing of medical devices.

Aligning closely with established international advisory on the subject the. The recommendations clarify what the fda recommends manufacturers include in submissions. Fda s role in 3d printing. The fda s center for devices and radiological health regulates firms who manufacture repackage relabel and or import medical devices.

The fda has previously issued guidance on the technical considerations for additive manufactured medical devices. In the press release accompanying the new document.