FDA Medical Device UDI requirements during import entry

UDI Requirements & labeling

The FDA would like to remind manufacturers and importers that most medical devices offered for import into the United States are required to meet the UDI requirements per 21 CFR 801, Subpart B and 21 CFR 830.300. The final rule published September 24,2023 established the requirement of a Unique Device Identification requirement for medical devices sold in the United States. It further requires device labelers to:

1. Include a UDI on device labels and packages, except where the rule provides for an exception or alternative. If a device is intended for more than one use and intended to be reprocessed before each use, the device labeler must also mark the UDI directly on the device.
2. Submit device information to the Global Unique Device Identification Database (GUDID).

Medical device entries that appear to lack a UDI on the label and/or a matching GUDID record for the device(s) may be subject to refusal at the port of entry.

Please reach out to your local DSV representative with any questions regarding this matter.