A comment suggested that the GUDID data requirement should be harmonized with what is collected for other device repositories globally.
Although FDA appreciates the goal of global harmonization and has structured this regulation to further those goals in many ways, FDA does not fully agree with this comment. We have designed the GUDID to meet the needs of the UDI system established by this rule, and we have carefully specified the data we believe are essential to the success of the system. The sponsors of other systems may have other objectives and may make different decisions.
LL. Information Required for Unique Device Identification--Information Concerning Each Version or Model of a Device-- SEC 830.310(b)
FDA received many comments concerning the specific information required under SEC 830.310(b). Two comments voiced support for inclusion of GMDN codes in the GUDID.
Most of the comments concerned the requirement to submit the GMDN code of a device to the GUDID, and the majority of those comments opposed collection of GMDN codes for the following reasons: At the time the proposed rule was published, the GMDN Agency required a license fee to be paid to obtain GMDN codes; comments expressed concern regarding whether the GMDN system has codes for HCT/Ps regulated as devices; and comments expressed a preference that additional nomenclature systems be utilized, such as the Universal Medical Device Nomenclature System (UMDNS) and the United Nations Standard Products and Services Code (UNSPSC). One comment suggested FDA allow GMDN codes to be voluntarily submitted as ancillary data under SEC 830.340.
FDA believes the bases for most objections to the requirement concerning GMDN codes have been eliminated. In the preamble to our July 10, 2012, proposed rule, FDA stated that the GMDN code would not be required unless GMDN codes were made freely available. The GMDN Agency has agreed to provide free access to GMDN nomenclature within the context of the GUDID data submission process. A labeler who reports data to the GUDID will be able to enter a GMDN code if the labeler knows it, or may use a module integrated in the GUDID reporting system to search for and select the correct GMDN term, including for HCT/Ps regulated as devices. Because of these actions and FDA's belief that the use of GMDN nomenclature will add precision and consistency to the identification of medical devices, FDA is including the requirement for submission of GMDN codes in the final rule.
One comment argued that requiring submission of GMDN information is "anti-competitive" and would allow the GMDN Agency to skirt the Sherman Antitrust Act.
FDA disagrees. Permitting the submission of device terms from more than one nomenclature system would undermine the purposes of this provision: Consistent terminology for the identification of devices. FDA does not believe reliance upon the GMDN classification system for this program will foreclose the use of alternative classification systems in other contexts. Accordingly, competition among classification systems should not be adversely affected. We also note that FDA as an agency of the Federal Government, FDA is immune from antitrust liability. See United States Postal Service v. Flamingo Indus., Ltd., 540 U.S. 736, 748 (2004); Name. Space, Inc. v. Network Solutions, Inc., 202 F.3d 573, 581 (2d Cir. 2000) (National Science Foundation has "absolute immunity from the antitrust laws").