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


FDA To Issue UDI Database Draft Guidance In March

This article was originally published in The Gray Sheet

Executive Summary

The draft guidance will serve as a user’s guide to the soon-to-be-released unique device identifier database, providing definitions for the device elements and attributes that companies have to submit to the database.

You may also be interested in...

FDA Reconsiders UDI Direct Marking Requirements For Implants

An agency official says FDA is reworking the UDI direct part marking requirements for implants and making other changes in the final unique device identification rule, due out in June.

IMDRF Issues Proposed Guidances On Device Auditors, Global UDI System

The International Medical Device Regulators Forum issued proposed guidance documents on monitoring of device auditing organizations, training for auditors and core elements of a global UDI system.

Regulatory News In Brief

FDA issues draft-guidance on accreditation of third-party reviewers for 510(k)s and final guidance for surgical ablation devices. More regulatory news.

Related Content


Latest Headlines
See All



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