A comment suggested that the requirement for submission of the proprietary, trade, or brand name of the device as it appears on the label of the device be expanded to permit the submission of "other names, if applicable."
FDA does not understand how "other names" would contribute towards improved identification of devices, and we have not added "other names" to the GUDID's requirements.
Approximately 16 comments recommended adding MRI compatibility information to the GUDID, while 2 comments specifically opposed inclusion of MRI compatibility information, and another 8 comments expressed general opposition to including any additional data element beyond those proposed in the
FDA agrees with the comments that suggest
One comment opposed inclusion of information in the GUDID concerning latex and whether the device is labeled as sterile, because GUDID is an "incomplete surrogate for appropriate and complete instructions for use" and these elements might discourage providers from reading the full labeling.
FDA believes this concern is misplaced, as we do not intend, and do not expect, the GUDID to be used in lieu of instructions for use provided on a device label or patient package insert. We have retained the requirements.
Several comments recommended significant expansion of GUDID reporting requirements to include additional data, including an indication that a device is either a prescription device or an over-the-counter device; the Healthcare Common Procedural Coding System Level II code; indications that a device is mercury free, Di(2-ethylhexyl)phthalate free, and thimerosal free; information on recalls, storage and handling conditions, hazardous warnings, radioactive isotopes data, and whether there is a Material Safety Data Sheets notice; an indication that hazardous materials and radioactive isotopes are present; "clinical attributes of the devices for meaningful post-market surveillance and research"; previously used NDC/NHRIC codes, the Systematized Nomenclature of Medicine Clinical Terms (SNOMED) CT identifier, and the Logical Observation Identifiers Names and Codes (LOINC) code for tests; all package-insert information submitted in structured product labeling (SPL) format or as a stable link; storage and handling conditions; and more. Most of these proposals appeared only in a single comment.
At this time,
MM. Enforcement Authority
One comment stated that the proposed rule does not articulate the enforcement actions for noncompliance and asked
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