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  • 1.  Hello fellow members

    Posted 16-Jan-2017 17:27
    Could anyone advise on the use of Rx symbol.
    Do all devices need to have Rx or only Class II and Class III. Doesn't this apply to Class I devices.

    Thanks,
    Aliva Das.



  • 2.  RE: Hello fellow members

    Posted 18-Jan-2017 10:09
    If your device is a prescription device, it should have the prescription statement or Rx Only symbol on it regardless of which class it is.  The Rx Only symbol is an alternative to the prescription statement that FDA has allowed since 2000 with this guidance:  http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072748.pdf

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    Margaret Mucha (FRAPS) [Director of Global Regulatory Affairs
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    Original Message


  • 3.  RE: Hello fellow members

    Posted 18-Jan-2017 11:56
    For a long time the Agency had exercised enforcement discretion over the use of the statement or symbol for a number of devices; however, over the past few years they've moved away from that approach and have begun asking for it to be included when appropriate.

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    Paul Swift, RAC
    Director, Global RA
    Fort Worth, TX
    United States
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    Original Message


  • 4.  RE: Hello fellow members

    Posted 18-Jan-2017 13:10
    In my experience, Margaret is correct. Any device that requires a prescription should be labelled as such. Additionally, a prescription statement or symbol is required to be exempt from certain requirements of adequate directions for use - Labeling Requirements - Exemptions From Adequate Directions For Use

    Also be aware that there are also size requirements defined for how prominent the symbols have to be.

    Best,

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    Michael Nilo
    Network Regulatory Partners
    Nilo Medical Consulting Group
    Portland OR
    United States
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    Original Message


  • 5.  RE: Hello fellow members

    Posted 18-Jan-2017 13:57

    Below are important points about the use of the "Rx Only" symbol.  Pay particular attention to point #6 below, because the the original question was about use of the "Rx symbol", without the word "only".

    1. Prescription devices do not require adequate directions for use by a lay person as long as the device's labeling bears the statement, "Caution: Federal law restricts this device to sale by or on the order of a (licensed healthcare practitioner)." (See 21 Code of Federal Regulations (CFR) sec. 801.109(b)(1)). 

    2. Without this prescription statement, the agency could consider the device misbranded under section 502(f)(1) of the Food, Drug, and Cosmetic Act (the act). A misbranded device is prohibited from entering into domestic commercial distribution.

    3. The FDA Modernization Act of 1997 (FDAMA) amended the act to require, at a minimum, that before dispensing, the labels of prescription drug products (must) contain the symbol statement "Rx only" instead of the "Caution: law prohibits dispensing without prescription." 

    4. FDAMA did not require this labeling change for prescription devices. 
       
    5. CDRH would like to minimize the burden on manufacturers, repackers, relabelers and distributors that face a variety of labeling requirements and changes. Therefore, CDRH, in its enforcement discretion, does not intend to object to the use of the statement "Rx only" as an alternative to the prescription device labeling statement "Caution: Federal law restricts this device to sale by or on the order of a (licensed healthcare practitioner)." 

    6. It is important to note that FDA intends to exercise its enforcement discretion only for the labeling alternative "Rx only." "Only" needs to immediately follow "Rx." However, the symbol statement "Rx only" does not necessarily need to be bracketed in quotation marks, and the word "only" may appear in upper or lower case letters, for example, Rx only, Rx Only, or Rx ONLY.  

    7. Complete information is available in FDA's guidance document "Alternative to Certain Prescription Device Labeling Requirements" issued on 1/21/2000. (http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072748.pdf) 

     Hopefully this information is useful and answers the question posed by Aliva.




    Original Message


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