Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

US FDA lays out tips, sets deadlines for UDI direct-marking of reprocessed devices

This article was originally published in Clinica

Executive Summary

Reprocessed and re-used life-sustaining and life-supporting devices, regardless of their classification, will need to have unique device identifiers (UDI) directly marked on them by September 2016 according to a new FDA draft guidance which lays out a timeline that would require all other necessary devices follow direct marking requirements by the end of 2020.

You may also be interested in...



Abbott Launches Five-Minute POC Rapid COVID-19 Test

Abbott is launching a second test to detect COVID-19. The diagnostics giant announced on 27 March the release of a rapid, point-of-care test that can deliver results within five minutes.

In A Bizarre Move, Trump Orders GM To Make Ventilators – Even Though The Auto Giant Already Is

President Trump on 27 March finally pulled the trigger on using his powers under the Defense Production Act, forcing General Motors Co. to manufacture medical ventilators. The only thing is, GM is already doing that.

Start-Up Spotlight: Iraq War Veteran Deploys ‘Bone Paint’ To Combat Traumatic Injuries

Theradaptive's “paint-like” regenerative therapeutic can be applied to any device to promote bone regrowth or regenerate tissue.

Topics

UsernamePublicRestriction

Register

MT102699

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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