Summary: Use of Symbols in Labeling (Final Rule) | FDA
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.
eCFR :: 21 CFR Part 801 -- Labeling
(F) The symbol statement “Rx only” or “℞ only” may be used as provided under § 801.109(b)(1). ( ii ) The use of symbols in device labeling which do not meet the requirements of paragraph (c)(1)(i) of this section renders a device misbranded under section 502(c) of the act.
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
Aug 30, 2024 · (1) The symbol statement "Rx only" or "RX 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...
Use of Symbols in Labeling | FDA
The Food and Drug Administration (FDA) issued a final rule, Use of Symbols in Labeling, June 15, 2016, that became effective September 13, 2016. The final rule permits the use of symbols in all...
21 CFR 801.15 -- Medical devices; prominence of required label ...
(F) The symbol statement “Rx only” or “℞ only” may be used as provided under § 801.109(b)(1). ( ii ) The use of symbols in device labeling which do not meet the requirements of paragraph (c)(1)(i) of this section renders a device misbranded under section 502(c) of the act.
The final rule also revises prescription device labeling regulations to allow the use of the symbol statement “Rx only” or “℞only” in the labeling for prescription devices.
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
Aug 30, 2024 · (F) The symbol statement "Rx only" or "RX only" may be used as provided under § 801.109 (b) (1). (ii) The use of symbols in device labeling which do not meet the requirements of paragraph...
Federal Register :: Use of Certain Symbols in Labeling
Apr 19, 2013 · FDA is also proposing to revise prescription device labeling regulations to authorize the use of the symbol statement “Rx only” on the labeling of prescription devices.
21 CFR § 801.109 - Prescription devices. - LII / Legal Information ...
(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 ...
Guidance for Industry: Alternative to Certain Prescription Device ...
Jan 21, 2000 · Through this guidance, the Center for Devices and Radiological Health (CDRH) announces that, in its enforcement discretion, it will apply a similar amended standard for labeling of prescription devices. Submit written comments concerning the guidance document at any time.