November 26, 2018
Authored and Edited by Ryan V. McDonnell; Kathleen A. Daley
FDA has a unique device identification (UDI) system designed to identify medical devices through distribution and use. FDA recently issued final Guidance stating its intent to delay enforcement of certain requirements for class I and unclassified devices and devices that must be directly marked. FDA reports that manufacturers and labelers faced substantial costs in bringing existing products into compliance with FDA’s UDI policy. To combat these costs, FDA states that it intends to phase in the UDI system published on September 24, 2013, superseding a previous compliance policy issued on January 16, 2018. In the Guidance, FDA states its intent to delay enforcement of requirements for standard date formatting, labeling, and global unique device identification database (GUDID) data submission, as well as direct mark requirements for certain devices, as detailed below:
Standard date formatting, UDI labeling, and GUDID data submission
FDA does not intend to enforce standard date formatting, UDI labeling, and GUDID data submission requirements before:
Direct marking
FDA does not intend to enforce direct marking requirements before:
The Guidance also states that FDA does not intend to enforce UDI direct mark requirements for class III, LS/LS, and non-sterile class II devices that were manufactured and labeled before the previously identified compliance dates when the device’s UDI can be derived from other information directly marked on the device, such as catalog numbers, lot numbers, and serial numbers. FDA intends the same for class I and unclassified devices that were manufactured and labeled before September 24, 2022.
FDA hopes the Guidance will reduce the risk of industry choosing to discard non-compliant devices rather than incur the additional costs to bring devices into compliance.
Readers may read the final Guidance, also available on FDA's website.
Copyright © 2018 Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.
DISCLAIMER: Although we wish to hear from you, information exchanged in this blog cannot and does not create an attorney-client relationship. Please do not post any information that you consider to be personal or confidential. If you wish for Finnegan, Henderson, Farabow, Garrett & Dunner, LLP to consider representing you, in order to establish an attorney-client relationship you must first enter a written representation agreement with Finnegan. Contact us for additional information. One of our lawyers will be happy to discuss the possibility of representation with you. Additional disclaimer information.
Conference
Best Practices in Intellectual Property– A Decade of Dedication to IP Excellence
April 8-9, 2024
Tel Aviv
INCONTESTABLE® Blog
The Federal Circuit’s Heartfelt Affirmation of Everybody’s Right to Use “Everybody vs. Racism”
March 22, 2024
Federal Circuit IP Blog
March 21, 2024
Due to international data regulations, we’ve updated our privacy policy. Click here to read our privacy policy in full.
We use cookies on this website to provide you with the best user experience. By accepting cookies, you agree to our use of cookies. Please note that if you opt not to accept or if you disable cookies, the “Your Finnegan” feature on this website will be disabled as well. For more information on how we use cookies, please see our Privacy Policy.
Finnegan is thrilled to announce the launch of our new blog, Ad Law Buzz, devoted solely to breaking news, developments, trends, and analysis in advertising law.