In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.
Inventory as of this Action
Requested
Previously Approved
36 Months From Approved
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The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA),. Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular
device or type of device such as devices sold over-the-counter and low risk devices. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient.The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.
US Code:
21 USC 519(f)
Name of Law: Unique Device Identification System
This is a new proposed rule, the rule will fulfill the statutory requirement of section 519(f) of the FD&C Act (21 U.S.C. 360i(f)), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
UDI PRA SS .doc
Third Party Disclosure (Ongoing)