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  • 1.  510k submission - Advertising/Promotion/Labeling materials for Medical Devices

    Posted 24-May-2016 11:13

    Hello all!

    I have a questions regarding the 510k submission. I couldn't find any information regarding the requirements for Advertising/Promotion/Labeling material for medical devices (except for the product label itself). In my case I work with Class II devices.

    I am preparing the 510k submission for a new device and I would like to know,  what kind of advertising and marketing material does the FDA requires to include in the 510k submission? Do I need for example to submit the brochures?  Is there any guidance or regulation  listing the required documents? Is there also any guidance with the requirement for developing the advertising material?

    Thanks in advance for the help,

    ------------------------------
    Carmen Herraez
    Regulatory Affairs
    Acrostak International Distribution Sàrl
    Geneva, Switzerland
    ------------------------------


  • 2.  RE: 510k submission - Advertising/Promotion/Labeling materials for Medical Devices

    Posted 24-May-2016 13:45

    Pursuant to 21 CFR 807.87, FDA requires that proposed advertising be included in the 510(k).  FDA reiterates this in its 1989 labeling guidance publication FDA 89-4203, as well as at FDA's "Device Advice" website.  According to the FDA, this includes "...posters...pamphlets...circulars...brochures...etc.", among other articles.

    In practice, if no advertising literature has yet been proposed at the time the 510(k) is submitted, then no advertising literature is required in the 510(k). In other words, FDA won't typically force the Sponsor to include advertising literature in the 510(k) as a precondition for clearance.

    The most important scenario where a Sponsor should consider including its advertising literature in the 510(k) is when:

    a) the literature includes claims that push the boundaries of the intended use / indications for use represented in the 510(k); and

    b) the Sponsor wants the added assurance of FDA review and specific clearance for such advertising claims.

    Hope this helps,

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States



  • 3.  RE: 510k submission - Advertising/Promotion/Labeling materials for Medical Devices

    Posted 24-May-2016 14:02

    Regarding FDA guidance for development of advertising, the aforementioned publication FDA 89-4203 includes guidance therein regarding “misbranding” and “false or misleading labeling”.  Those sections include FDA’s expectations for device advertising.  Remember also that advertising must be prepared and approved under appropriate document/change controls [21 CFR 820.40, 820.30(i), etc.].  Therefore any guidance that addresses change control will also apply to advertising development.

    In general, the FD&C Act requires that the advertising must not be “false or misleading in any particular”.  With specific respect to advertising, the FDA gives examples (non-exhaustive) of what would be considered to be “false or misleading”.  Here are some of those examples:

    • unsubstantiated claims of therapeutic value
    • ambiguity, half-truths, and trade puffery
    • expressions of opinion or subjective statements
    • failure to reveal material facts, consequences that may result from use, or the
    • existence of difference of opinion
    • deceptive pictorial matter
    • misleading testimonials

    These limitations are often the source of considerable tension between the regulatory affairs team and the sales/marketing team.  Therefore the most successful regulatory affairs teams are those that are willing to work with the sales/marketing teams in order to forge the most compelling advertising possible, but without overtly exceeding the aforesaid thresholds

    Hope this helps. Good luck!

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States



  • 4.  RE: 510k submission - Advertising/Promotion/Labeling materials for Medical Devices

    Posted 25-May-2016 11:21

    Hello Carmen,

    FDA does not need to "clear" or "approve" your advertisements (like they do for drugs). Generally the only labeling you need to submit will be the IFU, and possibly images or drawings of the packaging. 

    It helps to keep in mind the purpose of submitting information (including labeling) in a 510(k). You submit information so you can show that your device is substantially equivalent to the predicate device. To demonstrate substantial equivalence, you need to show (1) that your device and the predicate device share the same intended use and (2) that your device and the predicate have either the same technological characteristics or have different technological characteristics for which data has been submitted to demonstrate that such differences do not raise any different questions of safety and effectiveness.

    FDA's 2014 510(k) guidance points out that the labeling submitted with a 510(k) application is mainly for determining that first part of the substantial equivalence determination - intended use.

    The proposed labeling in a 510(k) is used to determine a device’s intended use (Section 513(i)(1)(E) of the FD&C Act). The indications for use statement in a 510(k) is also a factor in determining a device’s intended use. Consistency between the indications for use statement and the proposed labeling will facilitate the review of the 510(k).

    Basically, the IFU (and packaging) should not make claims for an intended use that is different from what is being proposed in the application. That is what the reviewer needs to confirm. (If there is special labeling guidance for your device-type, then the reviewer will generally need to confirm compliance with that, as well.)

    As the previous reply noted, generally your device is not marketed before clearance so it is neither expected nor required that advertisements be submitted in a 510(k).

    ------------------------------
    Beth Luoma
    Minneapolis MN
    United States



  • 5.  RE: 510k submission - Advertising/Promotion/Labeling materials for Medical Devices

    Posted 25-May-2016 15:38

    Good advice here all around.

    In case you are looking for guidance AFTER you've gotten 510(k) clearance, take a look at these in case it applies:

    Presenting Risk Information in Prescription Drug and Medical Device Promotion

    http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm155480.pdf

    Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices

    http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm401087.pdf

    Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices

    http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm401079.pdf

    Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices

    http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm285145.pdf

    ------------------------------
    Clarisa Tate
    Medical Device, RA & QA
    Bay Area, CA
    USA



  • 6.  RE: 510k submission - Advertising/Promotion/Labeling materials for Medical Devices

    Posted 26-May-2016 12:55

    Hi Carmen,

    Remember, too, that Instructions for Use and labels must be usability tested and written at no more than 6-8th reading level grade for lay users and 8-10th grade reading level for clinicians.

    Under 21 CFR 801 and 21 CFR 809, the FDA considers all medical documentation to be "labeling." Thus, documentation, including user  documentation, must be developed as part of the overall user-interface design and must be evaluated as part of overall risk management with regard to its usability and the mitigation of use-error risk.

    ------------------------------
    Joely Gardner PHD
    Usability Researcher and Professor
    San Marcos CA
    (760)994-6314
    joely.gardner@humanfr.com