Regulatory Open Forum

 View Only

  • 1.  Medical Device Claim

    This message was posted by a user wishing to remain anonymous
    Posted 08-Oct-2020 17:33
    This message was posted by a user wishing to remain anonymous

    Are you able to use the term "FDA Approved" in claims for products being sold in EU as medical devices? Thinking of having the same product SKU for US and EU.


  • 2.  RE: Medical Device Claim

    Posted 09-Oct-2020 03:02
    Hi Anon,

    I suggest to read this from FDA "https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved".
    Is the product really went through approval process or it was cleared?

    In general, statements on the labeling are only prohibited when they state something that is no true or it is misleading to the end user.

    Hope that helps

    ------------------------------
    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
    ------------------------------

    Original Message


  • 3.  RE: Medical Device Claim

    Posted 09-Oct-2020 07:11
    Hi Anon,

    You cannot state "FDA Approved" unless the device has a valid PMA approval.  If a device is marketed in the US via the PMN or 510(k) route, it is not "Approved" but is "Cleared".  Same for a De Novo device.  Personally, I don't see this as a "claim", but rather a simple statement of fact, similar to the idea that a product bearing a CE mark has no special value in the US.  I presume Sales/Marketing is pushing this and it is not worthwhile for the EU.  After all, you cannot sell in the EU without a CE mark.  That being said, FDA market authorization does have value in some countries, particularly LATAM.

    James

    ------------------------------
    James Bonds J.D.
    Director Regulatory Affairs
    Atlanta GA
    United States
    ------------------------------

    Original Message


  • 4.  RE: Medical Device Claim

    This message was posted by a user wishing to remain anonymous
    Posted 09-Oct-2020 08:45
    This message was posted by a user wishing to remain anonymous

    Probably not, since most medical devices in the USA are "cleared," (510(k) = premarket notification) not "approved," and 21 CFR 807.97:

    Any representation that creates an impression of official approval of a device because of complying with the premarket notification regulations is misleading and constitutes misbranding
    ​
    Original Message


  • 5.  RE: Medical Device Claim

    Posted 09-Oct-2020 09:46
    As was just posted in the above reply, be very careful about saying FDA Approved or FDA Cleared on the the labelling because the Agency does not take kindly to those kind of inferred endorsements.  Even if the device is approved through the PMA process, it would be fine to make a statement the device is Approved or Cleared in the United States, but be careful if there is any inference about FDA especially in sales materials.  They do not want the advertising or promotion to appear or seem like the FDA is endorsing the product or it is an endorsement by FDA.  When asked about putting approved or cleared on the product, I just tell people: do not do it.

    For the European Union it makes no difference what is said about the United States.  And vice versa, the CE Mark on products in the U.S. market do not mean anything.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


Related Content