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Fda is also revising its prescription device labeling regulations to allow the use of the symbol statement rx only or ℞ only in the labeling for prescription devices. While not included in this final rule, the fda will also be revising its prescription device labeling regulations to allow the use of the symbol statement rx only or ℞ only on prescription device labels. Prominence of required label statements

Use of symbols in labeling In a separate notice, the agency published a revised list of symbols it currently recognizes. (a) a word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 502 (c) of the act by reason, among other reasons, of:

Understand the meaning behind essential symbols for product identification, sterilization, usage, and safety.

However, manufacturers, repackers, relabelers, and distributors of prescription devices may wish to use the same symbol statement rx only as an alternative to the prescription labeling requirements, under sec (1) the symbol statement rx only or ℞ only or the statement caution Federal law restricts this device to sale by or on the order of a ___, the blank to be filled with the word physician, dentist, veterinarian, or with the descriptive designation of any other practitioner licensed by the law of the state in. Some medical devices include a label that reads rx only to indicate that they are only available with a prescription

This label indicates that the item is a prescription item, and that it should only be used under the guidance of a qualified healthcare provider Prescription devices must have a prescription in order to be used properly and be monitored, and the fda oversees them to. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted Fda is also revising its prescription device labeling regulations to allow the use of the symbol statement ``rx only'' or `` [rx] only'' in the labeling for prescription devices.

The final rule also clarifies the agency's definition of sdo, outlined required elements of the symbols glossary, and formally allowed for the use of rx only for devices only available with a prescription

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