What the Medical Device Manufacturers need to know about FDA’s UDI requirements?

All the medical device manufacturers that intend to place their devices in the US should label their devices considering the Unique Device Identifier (UDI) requirements. 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.?

What should a UDI contain?

A UDI should include the following:

1. Device identifier
2. 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 [email protected] with any questions and we can assist you in decoding the UDI requirements of the US FDA and help assign one for your device.?

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