FDA publishes final unique device identifier rule for medical devices

The US Food and Drug Administration (FDA) issued the final unique device identifier (UDI) rule on 24 September 2013, following up on the draft rule previously circulated by the FDA on 3 July 2012.

With limited exceptions, the rule requires that medical devices are labelled with a UDI in both a plain-text format and in a format that uses automatic identification and data capture (AIDC) technology, such as a barcode or radio-frequency identification. The UDI must be placed on the medical device labels and packaging and the UDI must include two parts: both a device identifier and a production identifier.

The device identifier corresponds to the version or model of the device, and the production identifier identifies the specific device through means such as the serial number, lot, batch, expiration date or date of manufacture. For a human cell, tissue or cellular and tissue-based product (HCT/P) regulated as a device, the production identifier can include the distinct identification code required for these devices under 21 C.F.R. §1271.290(c)…

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