Regulatory Open Forum

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  • 1.  E-commerce sites selling prescription-use only devices

    This message was posted by a user wishing to remain anonymous
    Posted 10-Jan-2022 12:29
    This message was posted by a user wishing to remain anonymous

    I am seeing many companies selling their devices through e-commerce sites without asking for a prescription, even though the devices themselves are prescription-use only.  Any insights on how they are selling online without scripts would be helpful!


  • 2.  RE: E-commerce sites selling prescription-use only devices

    Posted 11-Jan-2022 04:17
    Because the regulatory agencies do not have the resources or band-width to check every website selling products out there?  This unfortunately does happen and regulatory agencies like US FDA do periodically send notification to these sites.  There are some examples of FDA Warning Letters where companies are selling medical devices not cleared or approved; and maybe without proper verification as a prescription device.  Though it is more about self-monitoring where medical device companies should be ensuring their products are sold legitimately.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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