One comment suggested that
FDA disagrees with these suggestions. We have specified the criteria we believe are appropriate for our review of applications for accreditation as an issuing agency, and we are not persuaded that the UDI system needs, or would benefit from, more detailed accreditation criteria. As discussed in the response to the previous comment,
Having considered the comments submitted concerning
KK. Information Required for Unique Device Identification--
FDA received many comments (approximately 125) concerning these requirements.
Several comments we received requested a greater level of detail than we believe appropriate for this rule; nonetheless, many of these comments we expect to address in guidance on various aspects of the UDI system. Several comments asked for information or guidance concerning how to submit data to, and how to locate data in, the GUDID, or inquired about various technical aspects of the GUDID, such as security processes or whether or how the GUDID will be linked to other data systems.
Our general approach has been to regard a comment that did not suggest the need for a change to the regulatory language of this section as being a request for guidance. We will consider all such comments as we develop guidance concerning the final rule and the GUDID, and we plan to provide information concerning functions of the GUDID.
A comment asked whether the GUDID will accommodate reporting data concerning a device that has been assigned device identifiers under more than one issuing agency's system to assign UDIs.
The GUDID is being designed to accept data from multiple systems when necessary.
A comment suggested that each labeler should be allowed the flexibility to determine "what information will be reflected in the . . . GUDID." Some comments expressed concern that the publicly available GUDID may reveal proprietary information such as the number of devices manufactured.
FDA disagrees. Labelers are required to report only the type of production identifiers that appear on the label of the device to the GUDID, which would not reveal the number of devices manufactured.
A comment suggested the GUDID should not include company contact data, because it is typically a corporate officer whose contact information is not public. To serve as its point of contact with
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