Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Tackles 3-D Printing Considerations In Draft Guidance

This article was originally published in The Gray Sheet

Executive Summary

A draft guidance issued by FDA on additive manufacturing, or 3-D printing, of medical devices is meant to be a starting point for an industry that is growing exponentially. The document outlines recommendations on topics such as device design, software considerations and material testing requirements.

You may also be interested in...



3D-Printing Final Guidance Clarifies Manufacturing Practice Expectations

A year and a half after FDA issued a draft guidance to help makers of devices that rely on additive manufacturing, the agency has finalized the document in its bid to get ahead of the technology. The final guidance makes minor clarifications, but for the most is identical to the draft.

US FDA Works To Finalize 3D Printing Guidance; Industry Asks For More

A top FDA device official says the agency is hoping to finalize an additive manufacturing guidance this year. Industry is particularly interested in seeing the leap-frog guidance made final, but would also like to see more clarification and a separate guidance to address the topic of patient-specific manufacturing.

New FDA Web Page Aims To Clarify Position On 3D Printing

As industry awaits more guidance and clarification from US FDA about its regulatory oversight of 3D-printed devices, the agency is attempting to be more transparent with a new web page that outlines some of its current thinking and efforts on the topic.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

MT034776

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel