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  • 1.  FDA review of marketing claims

    This message was posted by a user wishing to remain anonymous
    Posted 21-Jun-2023 08:08
    This message was posted by a user wishing to remain anonymous

    Hello all.  I've heard it said that FDA "does not regulate marketing claims" for Class II devices.

    What does this mean, in practice?

    Let's say I want to claim my device operates 20% better than my other device.  Our RA says the company just reviews such claims internally.

    But previous companies I've worked at have all put a lot of effort into validating such claims to FDA, even if the claims weren't in the IFU.  FDA reviews their labeling, and as I understand anything on a company web site is considered labeling.

    Insight is appreciated!



  • 2.  RE: FDA review of marketing claims

    Posted 21-Jun-2023 08:15

    FDA does pay a lot of attention to your marketing claims, especially when you claim something that is beyond the approved intended use/indication statement in your submission. There have been many warning letters where FDA has determined that marketing claims are outside the scope of approved intended use. This will generally result into your product being "misbranded" in FDA's view. 

    Further, simply claiming "20% better than my other device" is not very specific. Better in what way? Are you claiming better clinical performance? Better reliability?

    Here is an example of a recent warning letter you may want to review. Look at the section "Unapproved Device Violations"

    https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/irhythm-technologies-inc-643474-05252023



    ------------------------------
    Naveen Agarwal, Ph.D.
    Problem Solver | Knowledge Sharer.
    Let's Talk Risk!
    @https://naveenagarwalphd.substack.com/
    ------------------------------

    Original Message


  • 3.  RE: FDA review of marketing claims

    Posted 22-Jun-2023 06:36

    Anon,

    The FDA does regulate claims for medical devices - they do this in conjunction with the FTC.  The Agency periodically reviews company's websites, looks at brochures during inspections, and reviews statements which companies make.  If there is some "claim" being made, then there should be documented evidence supporting this claims, such as our device performs 20% better.  Whatever that is, there should be testing supporting this claim.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: FDA review of marketing claims

    Posted 22-Jun-2023 09:18

    There are a few different possibilities for these difference. FDA does not "officially" approve advertising materials for devices like they do for drug products. But, for PMA devices, FDA often looks at your marketing claims as part of the PMA or a PMA supplement. As you say, then the company puts time and effort into making sure their substantiation will stand up to the scrutiny. The good news is, once you work through this process, you can be pretty certain FDA won't come back and question your claims.

    For 510(k) and exempt devices, the company does indeed "approve" the claims themselves. Generally companies use a cross functional group that includes regulatory and may include legal, compliance, even R&D if the claims are very technical or clinical if they are clinically based, etc. This internal process should be documented. Once this is approved you use the claims commerically. However, this does not mean there is no oversight. Once your claims are out there, FDA may indeed review them, and ask to see the data that substantiates them. They can become aware of your claims in many ways - most commonly from your website, but also from trade shows, reports by physicians or patients or even your competitors or legal cases.

    If FDA believes your claims are unwarrented, you can end up with an Untitled Letter or Warning Letter or other compliance actions. At a minimum, you will end up doing a lot of remedial work in those cases.

    I will note that if you are ever sued for product malfunctions, the plaintiffs attorneys LOVE to pick on the details of your marketing claims too. Thus, for products where the data is not submitted to FDA, it behooves you to maintain a robust internal process to make sure your company can really stand behind your claims.

    g-



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    Ginger Glaser RAC
    Consultant/Chief Technology Officer
    MN
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    Original Message


  • 5.  RE: FDA review of marketing claims

    Posted 22-Jun-2023 11:39

    Anonymous,

    You should look at the FDA/FTC Memo of Understanding to get a sense of the interplay between both agencies regarding labeling, advertising, and promotions.

    Good luck.

    will



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    William Coulston PMP, MS, RAC
    Director of Quality & Regulatory Affairs
    San Antonio TX
    United States
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    Original Message


  • 6.  RE: FDA review of marketing claims

    This message was posted by a user wishing to remain anonymous
    Posted 23-Jun-2023 08:10
    This message was posted by a user wishing to remain anonymous

    If you're being literal, FDA regulates advertising of restricted devices, which isn't well defined but is basically class III and a few other devices. FDA does have authority related to class II devices' intended use. So if what a company does is blatant, FDA can say it was promoting outside of its intended use and will exercise authority. You've probably seen this in warning letters, like the recent iRhythm letter. So, there is a difference based on classification, but I wouldn't put too much stock in it. It's still important to support your claims for FTC and for litigation, and FDA can still ding you if it's a bold enough claim that they can argue its outside of the intended use. 


    Original Message


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