Regulatory Open Forum

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  • 1.  "Forward looking statements" Disclaimer

    Posted 07-Dec-2021 13:43
    Hi All, been seeing a lot of "forward looking statements' disclaimers on websites/marketing material for medical devices.  Is this an acceptable safe harbor to regulators for future oriented claims re: devices under development?  Or do regulators (e.g. FDA) have a higher standard for potentially misleading claims?

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    Sandra Veenstra
    Director - Quality Assurance and Regulatory Affair
    Moncton NB
    Canada
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  • 2.  RE: "Forward looking statements" Disclaimer

    Posted 07-Dec-2021 14:25
    I have heard FDA has issues with future statements that could impact current patient safety today. For example, "Coming soon, a pill that cures some disease." The FDA would be concerned people in susceptible patient populations would be harmed in waiting for this unapproved treatment in lieu of currently approved treatments.

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    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
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    Original Message


  • 3.  RE: "Forward looking statements" Disclaimer

    Posted 08-Dec-2021 02:53
    Sandra,

    For me this would also fall under "claims" that an organisation would be making.  As Ed said, if there is a perceived shift in a person's treatment because they are waiting for something better, instead of getting treatment now, imagine many regulators would take exception to that.  Just like any claim, there needs to be substantiated evidence support any statements made, especially forward looking statements.  Now try to convince the sales and marketing teams of not making certain statements haha.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: "Forward looking statements" Disclaimer

    Posted 08-Dec-2021 05:25
    Hi Sandra,

    Forward looking statements are a part of SEC regulatory oversight and are directed to investors to allow a company "safe harbor" related to statements made about future events and to protect companies from securities law liability. Inclusion of any product claim of safety or efficacy in the statement would violate FDA regulations on promotional statements. The forward looking statements are based on management's then current views on events and outcomes and subject to certain risks and uncertainties. The important thing is that the statement is only relevant to facts or speculations at the time the statement that it accompanies is made. The point is that investments always carry some risk. However, these forward looking statements do not protect the company from knowingly false statements.

    Here is an example from SEC - https://www.sec.gov/Archives/edgar/data/885639/000119312504045654/dex991.htm

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    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States
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    Original Message


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