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


FDA Reconsiders UDI Direct Marking Requirements For Implants

This article was originally published in The Gray Sheet

Executive Summary

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.

You may also be interested in...

FDA Issues UDI Final Rule, Removes Direct Marking Requirement For Implants

The long-awaited unique device identifier final rule is intended to help FDA, device companies and health care providers track medical devices. The rule addresses many of industry’s concerns with FDA’s initial proposal and was met with general support by companies.

Cap On Mini-Sentinel Funds Raised To $135 Mil. To Support Powerful Surveillance Resource

Funds for FDA’s Mini-Sentinel post-market surveillance program were originally capped at $100 million based on projections for a consortium of at least three automated health care data partners to build analysis capabilities for data covering 100 million patients. The project has significantly exceeded those goals.

CDRH Details Path Forward For National Post-Market Surveillance System

The device center released an updated plan for post-market surveillance reforms, featuring a planning board that will establish a governing structure for the new system, as well as implementation dates for various post-market projects.

Related Content





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