The FDA has released a proposed rule that requires most medical devices distributed in the United States carry a unique device identifier, or UDI. Congress passed legislation in 2007 directing the FDA to develop regulations establishing a unique device identification system for medical devices (see FDA Amendments Act (FDAAA)). In announcing the proposed system, FDA said the numbers will conform to a standardized, alpha-numeric system of identifying elements, which will be contained within an FDA-run database.
The Associated Press reports the rule will be phased in following a 120 day public comment period. After the rule is finalized regulators plan to phase in the system starting with the highest risk devices. Devices sold over-the-counter at pharmacies and other retailers would not have to carry a code.
The extensive, 164-page proposed rule describes the UDI system and how devices are to be marked.
Some notable excerpts include:
- Devices intended to be used long-term and separated from its packaging will require the device itself to be labeled with a UDI, including implantable or multi-use medical devices and stand-alone software.
- All UDI information will need to be submitted to FDA’s proposed database of UDI information, known as the Global Unique Device Identification Database (GUDID).
- “UDIs will appear in both plain-text format and a format that can be read by a bar code scanner or some other AIDC technology.”
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