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  • 1.  labelling and advertising

    This message was posted by a user wishing to remain anonymous
    Posted 14-Mar-2017 17:15
    This message was posted by a user wishing to remain anonymous

    I am working with a start up that is creating fundraising press releases. The product function is described in these documents. Is this considered advertising? Also, these products do not require pre-market notification, so I am not sure what the boundaries are regarding product claims. Looking forward to your comments. Thanks in advance for your help.


  • 2.  RE: labelling and advertising

    Posted 14-Mar-2017 18:43
    They look at pre-release collateral just as advertising (press releases, investor materials, etc.) so therefore as labeling. Same with information that is posted on the internet.

    It is a little broader than script drug products... but by how much?

    Check out 21 CFR 801.109(a)(2)

    Even though the FTC governs unrestricted devices for advertising, the FDA still has authority over all devices.


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    Jennifer Travis
    Front Range Labs
    Loveland CO
    United States
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    Original Message


  • 3.  RE: labelling and advertising

    Posted 17-Mar-2017 11:10
    You really have two different question here.

    First - press releases etc targeted to the investment community. Generally FDA/FTC use enforcement discretion on this - thus you can describe the product, make claims etc. However, you need to be able to demonstrate that they are NOT targeted to/made available to, potential customers. This is generally done by which places you release the news release (financial press vs medical or broad) and how long you leave it up, which section of a website it is included in (once again, investor specific section). Document exactly how you will control this and make sure all claims are truthful.

    Second - how to determine what claims are ok for a device not requiring clearance. Assuming that the device is not exempt from 21CFR820, this is all tied to the design history file. What is the indication in the development documents? what claims does the DV/DVal testing support? Are there significant risks identified in the risk analysis (I'd guess not based on exempt status) that need to be disclosed? Use this DHF material as your guideline.

    g-

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    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    Maplewood MN
    United States
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    Original Message


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