Section 701(a) of the FD&C Act gives FDA the authority to issue regulations for the efficient enforcement of the FD&C Act. By requiring a UDI to appear on the label of devices, and by establishing the GUDID, the rule is designed to improve the accuracy and precision of adverse event reporting, as required by section 519(a) and (b) of the FD&C Act, which will enable FDA to more quickly and precisely identify device problems, such as safety and/or effectiveness concerns. Once a problem is identified, whether through improved reporting or otherwise, the presence of the UDI on the device label, packaging, in certain cases directly marked on the device itself, and in the GUDID will enable FDA to more efficiently and effectively respond, and protect the public health by addressing the problem using one or more of the regulatory tools that Congress has provided for this purpose, such as notification or mandatory recall under section 518 of the FD&C Act, tracking under section 519(e) of the FD&C Act, ensuring the adequacy of a voluntary recall with the assistance of reports of corrections and removals as required by section 519(g) of the FD&C Act, or seizing a device that is adulterated under section 501 of the FD&C Act and/or misbranded under section 502 of the FD&C Act. Thus, these provisions of the rule are issued under the authority of these sections in addition to the broad authority of section 519(f) of the FD&C Act.
The information required to be submitted to the GUDID under SEC 830.310 is necessary for UDIs to adequately identify devices through distribution and use, as required by section 519(f) of the FD&C Act. Collection of this information is further authorized by section 510(j) of the FD&C Act, which requires listing information to be accompanied by, at minimum, the label, package insert, and a representative sampling of any other labeling for the device (see section 510(j)(1)(B)(ii)). Most of the information required to be submitted to the GUDID is information that appears on the device label or in the package insert, and is included in the information that is required to be submitted to FDA by section 510(j).
The provisions of the rule that would require UDIs to be included in various FDA records and reports to FDA, allow the use of UDIs to identify devices subject to reports of corrections and removals and records of corrections of removals that are not required to be reported to FDA, and require reporting of UDIs in periodic reports for class III devices, are issued under the authority of sections 519 and 701(a) of the FD&C Act.
The provisions of the rule that would amend the Quality System Regulation by requiring examination of the accuracy of the UDI as part of the scope of the labeling inspection, that the device history record include any UDI or UPC, that complaint records include any UDI or UPC, and that the service report include any UDI or UPC, are issued under sections 520(f) (21 U.S.C. 360j(f)) and 701(a) of the FD&C Act.
The provisions of the rule that would require the inclusion of UDIs on reports regarding tracked devices is authorized by sections 519(e) and 701(a) of the FD&C Act.
The provision of the rule that would require that postmarket surveillance plans submitted to FDA include the device identifier of the devices involved is issued under sections 522 (21 U.S.C. 360 l), and 701(a) of the FD&C Act.