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Are there exceptions to the requirements for labeling of Medical Devices?

Yes. Reminder labeling is exempt from the requirements for adequate directions for use and adequate warnings. Reminder labeling, as defined in 21 CFR 201.100(f), is exempted. Reminder labeling calls attention to the name of the drug product but does not include indications or dosage recommendations for use. Reminder labeling may contain only the proprietary name of the drug, the established name of each active ingredient, and optionally, information relating to quantitative ingredient statements, dosage form, quantity of package contents, price, and other limited information.