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  • 1.  Professional Use Vs. OTC use devices.

    This message was posted by a user wishing to remain anonymous
    Posted 08-Oct-2019 13:55
    This message was posted by a user wishing to remain anonymous

    Hi All,
    we have a class I device that does not require any installation,training,maintenance etc. 
    It can be easily order and provided via the company's website.
    we would like to limit the intended use to professional use only.
    My question is, how do we as the manufacturer control the distribution of the device for professional use only? 
    should we put limitation in the company website ?  we have no control on who is placing the orders. 
    is labeling indicating for professional use only is sufficient ? 

    Many thanks in advance,


  • 2.  RE: Professional Use Vs. OTC use devices.

    Posted 10-Oct-2019 10:30
    For the prescription use devices, I have seen where companies have an agreement with distributors to only sell to professional sites. In your case, I would expect there to be some check at purchase to ensure it only goes to the professional. Since the device is still in the company's control at that point, it would seem to go against the indication for a consumer to be able to order directly from the company. 

    Any other thoughts out there RAPpers?

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    Maddi Myers
    Regulatory and Quality Project Manager
    Carver MN
    United States
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    Original Message


  • 3.  RE: Professional Use Vs. OTC use devices.

    Posted 10-Oct-2019 17:00
    Hi Maddi.

    While this isn't my specific area of expertise, the logic of you comment makes perfect sense.  If the company is only willing (or able) to sell to the professional sector, then they need to ensure that they have safeguards in place to ensure that they meet that requirement.  Otherwise, it really isn't a requirement any longer - is it?​

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    Victor Mencarelli
    Director Regulatory Affairs
    United States
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    Original Message


  • 4.  RE: Professional Use Vs. OTC use devices.

    Posted 11-Oct-2019 14:10
    One way is to require a professional license number as part of the order process. This works for direct sales; distributors are a separate story and would likely need to be controlled via contract.

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    Corey Jaseph RAC
    Director of Regulatory Affairs
    South Jordan UT
    United States
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    Original Message


  • 5.  RE: Professional Use Vs. OTC use devices.

    Posted 11-Oct-2019 14:42
    Edited by Julie Omohundro 11-Oct-2019 14:51
    The system I'm most familiar with restricts ordering to those who have passcodes. Physicians request a passcode from the company, and the company confirms they are physicians before issuing them a passcode.  I'm sure others have come up with other ways to do this.

    Putting a "Prescription Only" device up for order by whomever on the internet is the same as selling them to any passerby on the street.

    Also, if by "Class I" you are referring to FDA Class I, it seems to me that whether or not it is Rx only may affect its substantial equivalence to a predicate.  I'm not going to look up how it might affect its MDD or MDR classification, but it's certainly something I would look at, if it were my product.

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


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