FDA UDI Requirements for Medical Device Manufacturers
All medical device manufacturers intending to market their devices in the United States must comply with the FDA’s UDI Requirements when labeling their products. Unique Device Identifier (UDI) is a unique numeric or alphanumeric code that facilitates the identification, traceability, and tracking of medical devices during their distribution and use.
Recently, the FDA has suggested forms and contents of the Unique Device Identifier assist the manufacturers, labelers and the issuing agencies accredited by the FDA in understanding and decoding the requirements, and ensuring compliance with the final rule of the FDA for UDI.
Elexes supported 50+ meddevice clients in UDI compliance since 2015. As a QA/RA Director, this guide helps protect patient safety and stay FDA compliant with UDI timelines.
What should a UDI contain?
A UDI should include the following:
- Device identifier
- Production identifier
The device identifier defines the version and label of the medical device, whereas the production identifier could be batch/lot/serial number, expiry date, and manufacturing date.
How should UDI be presented?
The UDI should be presented in the following forms
- Easily readable plain-text
- Automatic identification and data capture technology
Does Software need a UDI?
Yes, a stand-alone software requires UDI. However, it depends on the way the standalone software is being distributed to the end-users.
If the software is distributed in a packaged form, an easily readable plain text shall display once the software starts. Also, the packages shall bear both the AIDC and the easily readable text.
However, if the software is not distributed via packages, the easily readable text shall display when the software starts or shall be displayed via menu command.
It is important to note that, in the case of SaMD, the software version shall be indicated in PI.
Please feel free to reach out to jennifer@elexes.com with any questions and we can assist you in decoding the UDI requirements of the US FDA and help assign one for your device.
Download UDI Compliance Checklist
FAQs
What are the FDA UDI compliance deadlines for Class I, II, and III devices?
– Class III: September 24, 2014
– Life-supporting/Life-sustaining & Implantable devices: September 24, 2015
– Class II: September 24, 2016
– Class I & Unclassified: September 24, 2018 for labeling/GUDID; direct-marking for reusable devices by September 24, 2020Is UDI marking required on all medical device labels?
All devices must bear a UDI on their labels/packages unless exempted under the rule.
How to submit UDI data to the FDA GUDID database?
Obtain a GUDID account; then submit DI records via manual web entry or HL7 SPL files through the FDA Electronic Submissions Gateway.
How does EU MDR UDI differ from FDA’s UDI system?
– EU MDR uses a “Basic UDI-DI” for grouping related devices (not required on labels) whereas FDA does not have a Basic UDI-DI concept.
– EU mandates UDI data submission to EUDAMED; formats & timelines differ.What device data elements are required in GUDID registration?
– Device Identifier (DI) + brand/model/version + device description
– Labeler info (company name, address, DUNS)
– Regulatory elements (FDA Product Code / Premarket submission numbers)
– Packaging info, sterilization, size, storage/handling, commercial distribution & status
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