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 Beefs Up Its UDI Direct-Marking Preferences In Final Guidance

Executive Summary

US FDA's device center has made some clarifications to the way it would like to see sponsors directly mark medical devices intended to be reprocessed and reused, and it has beefed up its preferred approach to Unique Device Identification labeling in a final guidance on direct UDI marking released Nov. 16.

You may also be interested in...



Direct-Marking UDI Draft Lays Out Tips, Timelines For Reprocessed Devices

The agency issued draft guidance document on direct marking requirements for unique device identifiers, seeking guidance on the definition of "reprocessing" and laying out timelines.

White House To Deliver 25 Million Face Masks To Low-Income Americans

The White House will be spending $86m to provide tens of millions of coronavirus masks to poorer American households.

HHS Secretary Nominee Becerra Commits To Telehealth Expansion, Procedure Price Transparency

At two recent confirmation hearings, HHS secretary nominee Xavier Becerra promised Senators he would help expand telehealth and procedure price transparency.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT121780

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