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CSMS # 56355955 - FDA Medical Device Unique Device Identifier requirements review during import entry
On September 24, 2013, the FDA published the final rule, Unique Device Identification (UDI) System (the “UDI rule”), which established a system to adequately identify medical devices sold in the United States from manufacturing through distribution and use. The goal of the UDI system is to ultimately improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation.
In part, the UDI rule requires device labelers (defined in 21 CFR 801.3 (for many devices the labeler is the manufacturer)) to:
1. Include a UDI on device labels and packages, except where the rule provides for an exception or alternative.
a. 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).
The UDI rule was implemented using a phased approach for the device labeling and GUDID submission requirements based on device risk, with the highest risk device class, class III, having to comply by September 24, 2014. September 24, 2016, was the compliance date for class II devices and December 8, 2022, for class I and unclassified devices.
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.
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.
If the entry is detained due to UDI/GUDID violations, the Importer of Record may submit an Application For Authorization to Relabel or Recondition Non-Compliant Articles (FORM FDA-766) in an attempt to bring the product into compliance. See the FDA’s Reconditioning of Imported FDA-Regulated Products webpage for more information.
Additional information on UDI compliance can be found at the following links:
For questions regarding UDI and GUDID requirements, the UDI Helpdesk may be contacted at the following link: https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/fda-udi-help-desk.
General questions regarding the FDA’s import process may be submitted to: Imports@fda.hhs.gov.
Entry-related and/or entry status inquiries should be submitted to the FDA Import Office handling your entry. The following link will help in identifying the corresponding FDA Import Office associated to the port of entry Import Offices and Ports of Entry | FDA.
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