Hospitals

FDA Guidance on 3D Printing a ‘First Step’

by Joyce Frieden, News Editor, MedPage Today

 

WASHINGTON — The FDA’s recently issued draft guidance on 3D-printed medical devices does not answer one big question related to physician involvement with such devices, an expert said here.

“One of the biggest unknowns is whether a physician who 3D-prints a med device in the hospital or his or her own office would be considered a manufacturer for tort liability purposes,” said Matt Jacobson, JD, of the Reed Smith law firm. “No one knows what the answer is going to be.”

The draft guidance, which was issued Tuesday by the agency’s Center for Devices and Radiological Health and its Center for Biologics Evaluation and Research, outlines recommendations for design, manufacturing, and testing of 3D-printed devices, which the FDA refers to as “additive manufactured” devices because of their use of additive layers of materials.

The FDA emphasized that this guidance is a “leap-frog guidance.” “Leap-frog guidances are intended to serve as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development,” the agency wrote. “This leap-frog guidance represents the Agency’s initial thinking, and our recommendations may change as more information becomes available.”

 

READ THE REST HERE

 

Print Friendly, PDF & Email
Tags

Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

Related Articles

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Back to top button
Close