A few comments suggested that FDA serve as an issuing agency, or as the only issuing agency.
FDA does not agree and notes the suggested approach could require labelers that have voluntarily labeled their devices with UDIs to assign new UDIs to comply with the rule. We believe the UDI system will be best served if qualified private organizations that have relevant experience operate the day-to-day technical aspects of the UDI system. In addition, we have removed the provision that would have allowed a State agency to serve as an issuing agency. Although FDA may act as an issuing agency if it is necessary or appropriate for us to do so (see SEC 830.200 of the final rule), we believe that FDA's expertise and resources are best applied to other functions.
One comment suggested that FDA address the constitutionality of the requirement that companies contract with third-party non-government companies or agencies that may impose their own requirements on a manufacturer that may exceed FDA's regulatory authority, such as fees for service. This comment stated that, constitutionally, the government may not assign a government function to non-governmental entities. This comment appears to be directed at the requirement at SEC 830.20 that UDIs be issued under a system operated by FDA or an FDA-accredited issuing agency and conform to certain international standards regarding issuing agencies.
While FDA recognizes the constitutional limitations regarding the delegation of functions to private entities, FDA has not impermissibly delegated any governmental authority to issuing agencies or any other entities in this rule. Rather, the role that this rule creates for issuing agencies to serve in the unique device identification system is one that is ministerial and completely subordinate to FDA's ultimate authority over the compliance of unique device identifiers with the FD&C Act, these regulations, and the international standards incorporated by reference in the regulations. (See, e.g., Sunshine Anthracite Coal Co. v. Adkins, 310 U.S. 381, 399 (1940) (upholding Congressional delegation of function to private entity because "members of the [private entity] functioned subordinately to the [public agency]," which had "authority and surveillance" over the private entity); Pittston Co. v. United States, 368 F.3d 385, 395 (4th Cir. 2004) ("Congress may employ private entities for ministerial or advisory roles, but it may not give these entities governmental power over others." (citing Sunshine Anthracite, 310 U.S. at 399, United States v. Frame, 885 F.2d 1119, 1129 (3d Cir. 1989), cert. denied, 493 U.S. 1094 (1990))). Issuing agencies will be performing the ministerial function of issuing unique labeler codes for device identifiers and operating a system of identifier creation and maintenance focused on ensuring the uniqueness of alphanumeric codes, as the entities currently in existence already do. No UDI provides any advantage over any other UDI. FDA retains a high degree of control over the issuing agencies through the requirements providing that issuing agencies must be accredited by FDA, that FDA may suspend or revoke of an issuing agency's accreditation, and that FDA may act as issuing agency if necessary or appropriate. (See subparts C and D of part 830 of the final rule.)