Aug 29 2022
All devices are subject to the requirements of the UDI Rule, unless an exception or alternative has been granted. This guidance provides clarification of key provisions of the UDI Rule.
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Understanding the UDI Format
A unique device identifier (UDI) is a unique numeric or alphanumeric code that generally consists of the following:
Device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
Production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
Lot or batch number within which a device was manufactured
Serial number of a specific device
Expiration date of a specific device
Date a specific device was manufactured;
Distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.
The device labeler must provide the UDI in two forms on labels and packages:
Easily readable plain-text
Machine-readable form that uses automatic identification and data capture (AIDC) technology.
Dates on the Device Label
Whenever the label of a medical device includes a printed expiration date, date of manufacture, or any other date intended to be brought to the attention of the user of the device, the date must be presented in the following format: the year, using four digits; followed by the month, using two digits; followed by the day, using two digits; each separated by hyphens.
The standard date format is required for all medical devices unless excepted. This change should be implemented on the device label by the UDI compliance date for that device.
Class I devices subject to UDI requirements
Class I devices are subject to UDI requirements, with certain exceptions: 1. Class I devices are not required to include a production identifier (PI). 2. Class I devices that bear a Universal Product Code (UPC) on their labels and device packages are deemed to meet all UDI labeling requirements of 21 CFR 801 subpart B. 21 CFR 801.40(d). Labelers of such devices would still be required to comply with requirements to submit data to the GUDID. 3. Class I devices that FDA has by regulation exempted from the good manufacturing practice requirements of 21 CFR 820 (other than record keeping requirements and complaint files) are excepted entirely from UDI requirements.
510(k) exempt products subject to UDI requirements
Unless an exception applies. There is no general exception for 510(k) exempt products.
Humanitarian Use Devices (HUDs) subject to UDI requirements
They are Class III medical devices and have the same compliance dates as other Class III devices. (Unless an exception applies)
May a labeler request an exception from UDI labeling requirements for situations not covered by the general exceptions identified in 21 CFR 801.30?
Requests involving an exception or alternative to UDI requirements that do not fit into the categorical exceptions of the final rule may be submitted by the labeler and evaluated by FDA according to the process and criteria described in 21 CFR 801.55 --- Request for an exception from or alternative to a unique device identifier requirement.
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