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FDA Audit Medical Devices

  • 1.  FDA Audit Medical Devices

    This message was posted by a user wishing to remain anonymous
    Posted 06-Dec-2017 11:23
    This message was posted by a user wishing to remain anonymous

    ​​Hi ,

    Is the marketing material review  in the scope of the FDA QSIT audit ?

    Thanks & regards


  • 2.  RE: FDA Audit Medical Devices

    Posted 06-Dec-2017 11:47
    During a QSIT inspection, FDA may review marketing literature in association with the design output step when inspecting the design control subsystem.  This is because marketing literature is considered to be "labeling", and FDA reviews labeling as a design output (see page 38 of the QSIT Manual).  Some additional rationale is given below.

    FDA has stated that, according to an appellate court decision: "...Most, if not all advertising, is labeling..." Section 201(m) of the U.S. Food Drug and Cosmetic Act defines "labeling" as, "...all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article."  FDA interprets the term "accompanying" very liberally and includes marketing literature in this association.

    Hope this helps.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
    Copyright 2017 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 3.  RE: FDA Audit Medical Devices

    Posted 12-Dec-2017 08:40
    One other thing to note - if you have marketing literature set out, say in the lobby of your building, an FDA inspector is free to pick it up, even in a QSIT inspection. Typically they do this "to better understand your products" but of course they can take it further if they want. Generally it is a good idea to clear this material out as part of your inspection preparation process, if you don't want it pulled into the inspection file.

    g-

    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
    ------------------------------

    Original Message


  • 4.  RE: FDA Audit Medical Devices

    Posted 13-Dec-2017 06:05
    I don't have the time this morning to comment fully on this and I'm frustrated I can't provide a more thorough explanation, but too many companies provide marketing materials to FDA during inspections because a) the promotional review process is made part of their quality system, instead of separated and independent ( in effect consenting to jurisdiction), and b) acquiescing to an expanded view of statutory audit authority.  I have many they times told the Center folks and their lawyers their request is inappropriate, citing the intent behind the statute, and they drop it.  Of course sometimes we give in when the systems are not separate and it is not worth the effort because the request is innocuous.

     Kevin is right and wrong at the same time.  I don't have time to elaborate.  FDA has no authority inspect advertising and promotion under the First Amendment but can act on offending pieces, but do you want them mucking around in advertising concept development files, etc. during an inspection?  Of what relevance is that to the statutory idea behind the inspection?  FDA will always be aggressive about asserting their authority. 

    Mark DuVal, JD, FRAPS
    President & CEO
    DuVal & Associates, P.A.


    Sent from my Verizon, Samsung Galaxy smartphone



    Original Message


  • 5.  RE: FDA Audit Medical Devices

    Posted 13-Dec-2017 12:38
    We have experienced numerous FDA audits and have not had inspections of marketing materials. We do not put our marketing materials in the lobby or the room where we house the FDA auditors, either. This is not to say that FDA does not review websites prior to their visit, but we have not had any inspectors ask for these types of materials, and we are audited about every two years.

    ------------------------------
    Corey Jaseph RAC
    Regulatory Affairs Manager
    Ultradent Products, Inc.
    South Jordan UT
    United States
    ------------------------------

    Original Message


  • 6.  RE: FDA Audit Medical Devices

    Posted 14-Dec-2017 07:24
    Hi Mark,

    I believe your comments are quite on point.  FDA certainly has the statutory authority to pursue enforcement regarding marketing materials that are offending to the FD&C Act, but not to proactively investigate the internal procedures that companies use to develop and approve those materials.  FDA has had a poor judicial track record recently in trying to balance their enforcement authority with First Amendment freedoms, but your remarks regarding companies ceding the issue to FDA are appropriate.

    I believe the best course is to keep all development of marketing materials out of QS scope, with only the final review and approvals being with the QS as an element of labeling.  Of course, that is not to say that those materials should be developed in a vacuum but rather involve cross-functional input outside of the QS.

    Regards,
    James Bonds, JD




    Original Message


  • 7.  RE: FDA Audit Medical Devices

    Posted 13-Dec-2017 17:02
    Edited by Kevin Randall 13-Dec-2017 17:05

    I just had an FDA QSIT inspection that wrapped up yesterday.  Very early in the inspection, the investigator requested, reviewed, and took copies of, the firm's advertising literature.  I experienced the same in a QSIT inspection at a different firm earlier this year.  For folks contemplating an argument with such a request, here are some points to consider:

    1. The appellate court decision I mentioned before states that, "...Congress did not, and we cannot, exclude from the [labeling] definition printed matter which constitutes advertising..."
    2. FDA believes that unsubstantiated claims in medical device advertising are contrary to public health.  Accordingly, section 502 of the FD&C Act declares a device to be misbranded if its labeling is false or misleading in any particular.
    3. To enforce the foregoing statutory requirement, section 704 of the FD&C Act gives FDA the authority to inspect medical device labeling.
    4. FDA Warning Letters often cite unsubstantiated advertising claims discovered in labeling by FDA during inspections.
    5. FDA promulgated 21 CFR 820.181(d) requiring medical device labeling to be prepared and approved using the formal document controls of 21 CFR 820.40. This applies to the labeling of all medical devices that aren't GMP-exempt. In addition, for devices subject to design controls, the 820.181(d) requirement is compounded by 820.30(d) requiring labeling to be documented, reviewed, and approved before release.
    6. Not only does FDA review medical device advertising under the aforesaid authority of the FD&C Act, but also under the authority of other statutes. For example, last time I checked, the FDA and the FTC had a liaison agreement in place for the review of medical device advertising, and FTC says that advertising includes labeling.


    A fight with FDA about these relatively unambiguous statutes (i.e., laws) and implementing regulations seems to be more trouble than it's worth. I'm definitely not a lawyer; but even if I was (or hired a good one), I can't see how it's possible to overcome the existing legal precedent and aforementioned statutory/regulatory requirements giving FDA authority to inspect medical device labeling during a QSIT inspection.


    Hope this helps.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
    Principal Consultant
    ComplianceAcuity, Inc.
    Golden CO
    United States
    www.complianceacuity.com
    Copyright 2017 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 8.  RE: FDA Audit Medical Devices

    Posted 14-Dec-2017 06:29
    Some weeks ago a client of mine was visited by the FDA in particular because of some misleading information they had in their website.

    I also remember a 483 some years ago related to drugs that I found interesting: the FDA people went to the company website and, in the search box, put the work "cancer". The results included links to products which were not cleared for cancer. FDA mentioned that this may mislead consumers. 

    This last example may be a stretch, but it shows that the Agency does have a focus in marketing material, also.

    Which is not a new thing, because, historically, of one the reason the FDA was created and created regulations was to deal with misbranded products

    ------------------------------
    Marcelo Antunes RAC
    Regulatory Strategy Consultant
    SQR Consulting
    Sao Paulo
    Brazil
    ------------------------------

    Original Message


  • 9.  RE: FDA Audit Medical Devices

    Posted 17-Dec-2017 18:09
    Hi Kevin,

    A fight with FDA about these relatively unambiguous statutes (i.e., laws) and implementing regulations seems to be more trouble than it's worth. I'm definitely not a lawyer; but even if I was (or hired a good one), I can't see how it's possible to overcome the existing legal precedent and aforementioned statutory/regulatory requirements giving FDA authority to inspect medical device labeling during a QSIT inspection.

    Definition of labeling is quite broad including promotional material or advertising literature.  Some info on labeling may invoke First Amendment claim as it may/can be considered as "Opinion."

    Labeling that can be considered as mere "opinion" may not be best to handle the opinion as part of the document control for justifiable reasons. 

    In fact, label and labeling content, opinions or conclusions are not reportable in 483s. But there are some exceptions. Because of the applicable exceptions, it is expected that FDA investigators may still demand labeling information.   

    What is important though is to make sure that labeling including opinion is presented in a TABN manner!

    Thank you.

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    REGULATORY DOCTOR
    Phone (Toll-Free): 1-(800) 321-8567

    NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.





    Original Message


  • 10.  RE: FDA Audit Medical Devices

    Posted 14-Dec-2017 13:13
    I'm thankful for Mark's and James' qualified legal perspectives.  Yet it seems we should carefully maintain a particular distinction in this discussion: Specifically, a distinction between 1) FDA's fundamental authority to regulate and inspect medical device labeling/advertising; versus 2) FDA's authority (i.e., the lack thereof) to regulate/violate free speech.

    I infer that the context of the First Amendment issues mentioned by Mark and James is the context involving dissemination / discussion of "off-label" use.  Mark/James, please clarify if possible.  The issue of off-label use has of course been a messy topic for many years.  And clearly, FDA's authority to regulate free speech is limited by the First Amendment as demonstrated by FDA's recent unsuccessful efforts to curb such free speech.

    But the original question asks if FDA has the authority to review medical device marketing materials during an FDA inspection.  The statutes, regulations, legal precedent, and experiences I cite indicate that FDA clearly has the authority to review marketing materials during an inspection.

    Mark/James: Is it your opinion that firms are wise to refuse FDA when it attempts to inspect marketing materials for compliance with 21 CFR 820.181(d) [requiring medical device labeling to be prepared and approved using the formal document controls of 21 CFR 820.40] and/or 820.30(d) [requiring labeling to be documented, reviewed, and approved before release]?

    Thanks in advance for any further insights you can give to the Forum.

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

    Original Message


  • 11.  RE: FDA Audit Medical Devices

    Posted 15-Dec-2017 10:33
    I'll add on to this question with "and does the advise change with whether the device is restricted (which has an explicit regulation that approvals and history of marketing material must be kept) or unrestricted (which to my knowledge has no similar requirement).

    g-

    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
    ------------------------------

    Original Message


  • 12.  RE: FDA Audit Medical Devices

    Posted 16-Dec-2017 09:04
    Hi,

    I think that the distinction is between the marketing material development process not being within FDA's inspectional jurisidiction, where the approval of labeling, including marketing materials, being within their review bounds.   FDA should not be able to see drafts of marketing material, potential claims that were considered and discarded, and the reasoning for accepting/discarding particular wording.  They should only see the final product that is actually used, not the fruits of the iterative process in getting there.

    James



    Original Message


  • 13.  RE: FDA Audit Medical Devices

    This message was posted by a user wishing to remain anonymous
    Posted 26-Dec-2017 09:20
    This message was posted by a user wishing to remain anonymous

    ​Thanks everybody for your valuable feedback. Now I seek your advice; just before the FDA audit , is it advisable to alter the marketing information on the company website .

    Thanks ,
    Original Message


  • 14.  RE: FDA Audit Medical Devices

    This message was posted by a user wishing to remain anonymous
    Posted 26-Dec-2017 09:20
    This message was posted by a user wishing to remain anonymous

    ​Hi,

    Thanks for your feedback. Before the audit , is it advisable to alter the website details to comply with the FDA requirements..
    Original Message


  • 15.  RE: FDA Audit Medical Devices

    This message was posted by a user wishing to remain anonymous
    Posted 26-Dec-2017 09:20
    This message was posted by a user wishing to remain anonymous

    ​Can you advise if the website information can be /should be revised , if required before the audit ?
    Original Message


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