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e-CFR data is current as of June 10, 2021

Title 21Chapter ISubchapter HPart 801Subpart B → §801.40


Title 21: Food and Drugs
PART 801—LABELING
Subpart B—Labeling Requirements for Unique Device Identification


§801.40   Form of a unique device identifier.

(a) Every unique device identifier (UDI) must meet the technical requirements of §830.20 of this chapter. The UDI must be presented in two forms:

(1) Easily readable plain-text, and

(2) Automatic identification and data capture (AIDC) technology.

(b) The UDI must include a device identifier segment. Whenever a device label includes a lot or batch number, a serial number, a manufacturing date, an expiration date, or for a human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device, a distinct identification code as required by §1271.290(c) of this chapter, the UDI must include a production identifier segment that conveys such information.

(c) If the AIDC technology is not evident upon visual examination of the label or device package, the label or device package must disclose the presence of AIDC technology.

(d) A class I device that bears a Universal Product Code (UPC) on its label and device packages is deemed to meet all requirements of subpart B of this part. The UPC will serve as the unique device identifier required by §801.20.

[78 FR 58818, Sept. 24, 2013]

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