FDA Extends UDI Deadline for Class I Devices

Tweet

June 2, 2017
By: Frederic D. Van Arnam, Jr.

On June 2, 2017, the U.S. Food and Drug Administration (FDA) issued a letter stating its intent to extend by two years the Unique Device Identifier (UDI) compliance deadline date for Class I and unclassified medical devices.  

According to the letter, the FDA will issue a guidance document in which it will exercise its enforcement discretion to push off the upcoming September 24, 2018 compliance deadline. The new compliance deadline will now be September 24, 2020.  This action will not apply to Class I devices and unclassified devices that are life supporting or sustaining, as labelers of those devices must already comply with the UDI requirements

For more information or if you have questions, please contact Rick Van Arnam at rvanarnam@barnesrichardson.com