UDI Guidance Covers Testing, Other Considerations

Companies labeling products with unique device identifiers should test the automatic identification form of the UDI to make sure it can be reliably scanned by the appropriate technology.

The FDA clarified expectations on unique device identifiers, which must appear in two forms on device labels and packages: an easily readable plain-text form and an automatic identification and data capture technology form, a new FDA draft guidance says.

If a labeler chooses a bar code form of AIDC, it should also be tested for print quality, accounting for the expected handling and use life of the device. Labelers should discuss print quality requirements with their FDA-accredited issuing agency. — April Hollis