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  • 1.  Website Control

    This message was posted by a user wishing to remain anonymous
    Posted 02-May-2022 15:25
    This message was posted by a user wishing to remain anonymous

    Good morning community,

    I would like to understand how other companies revise their website, in the most efficient way possible and maintain regulatory/ISO13485 compliance?  Specifically, the documentation control portion of the revision?  Do you:

    1.   Convert the website to pdf, redline, and change order release?  (Note:  This is extremely time consuming)
    2.  Only refer to the website and indicate the changes? Pros/Cons?
    3.  Other suggestions?
    4.  In addition, how do you work with marketing to complete your SEO optimization (improving the quality and quantity of website traffic to a website or a web page from search engines) which occurs on a monthly basis?  Change order release each suggested optimization?


  • 2.  RE: Website Control

    This message was posted by a user wishing to remain anonymous
    Posted 04-May-2022 06:59
    This message was posted by a user wishing to remain anonymous

    As you have recognized, your website must be treated like any other advertising/promotional material.  FDA has responsibility for misbranding/labeling aspects and advertising for "restricted" devices (generally PMA approved devices).  FTC aspects come into play for non-restricted device advertising/promotion.

    In either case, your change control system for your website should clearly document the changes, proper review/approval of those changes by qualified personnel, and justification to support the claims made.

    In my experience, we've converted web pages to pdf or other human-readable format and identified changes.   The changes can be identified by redlines (either directly editing pdf, using pdf file compare tools (rev A to rev B comp), or a complete separately-written description of the change (eg, "in paragraph 2, the following sentence was added...")

    For SEO or other "hidden" aspects of the webpage, these are also part of the review if any of these hidden aspects of the webpage can be produced by a search engine or take the form of other human-readable text.  The last thing you want is for Google to index a page header that contains an unsupportable claim that regulatory did not review because it wasn't part of the body of the webpage.
    Original Message


  • 3.  RE: Website Control

    Posted 04-May-2022 10:16
    For us we have the person capable and authorized to make changes to safeguard claims and other controlled statements. This way tradeshows, new hires etc can be updated without a change control notice. This person keeps a log of what was changed each time and requests change control as needed.

    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 4.  RE: Website Control

    This message was posted by a user wishing to remain anonymous
    Posted 05-May-2022 09:58
    This message was posted by a user wishing to remain anonymous

    Agree with Ed in that your change control procedures should be explicitly flexible enough to permit non-claim changes to your website (eg, management changes, announcements of presence at tradeshows, etc) to have reduced review/approval requirements.  Usually just marketing would suffice for such changes, but even these changes should be recorded/logged.  I have often seen them recorded as "administrative" changes.

    Word of caution, however.  Be sure your marketing person is experienced enough to recognize what might be a claim.  I have seen, for example, that just the title of an upcoming symposium may contain claims.  So a simple announcement of "Come see us at Booth 17 for a presentation on the [insert subtle claim here]" can be missed as a claim by marketing.
    Original Message


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