FDA Grants UDI Labeling Extension to Lower-Risk Devices
Responding to requests from numerous stakeholders, the FDA extended its unique device identification compliance dates for certain Class I devices and unclassified devices, such as manual surgical tools and mechanical wheelchairs from September 24, 2018 to September 24, 2020.
More than 4,000 device labelers have already made over 1.4 million UDI submissions, according to CDRH’s Office of Surveillance and Biometrics.
Class III devices were already required to comply.
The FDA plans to issue new guidance on enforcement of device-labeling policies. The agency will also seek more feedback from stakeholders and industry leaders on the challenges they face and how to make the best use of existing data on higher-risk devices.