V. Information Collection Requirements
This final rule contains information collection requirements (OMB control 0910-0720) that are subject to review by the
Title: Unique Device Identification System
Description: In accordance with the collection of information entitled "Unique Device Identification System (UDI)," medical device labelers, unless excepted, are required to design and use medical device labels and device packages that bear a UDI, present dates on labels in a particular format, and submit data concerning each version or model of a device to the GUDID no later than the date the label of the device must bear a UDI. Once a device becomes subject to UDI requirements, respondents will be required to update the information reported whenever the information changes. Respondents required to submit data to the Agency under certain other information collections are required to include the UDI for the device that is the subject of such information collection.
Section 801.18 requires that whenever a labeler of a medical device includes an expiration date, a date of manufacture, or any other date intended to be brought to the attention of the user of the device, the labeler must present the date on the label in a format that meets the requirements of this section. Section 801.20 requires every medical device label and package to bear a UDI. Under
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