Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​​Hi,

Based on the details shared in a related discussion, on this topic , is it advisable to alter the advertising material including website information before the audit, assuming FDA would have already accessed the same.

regards,

FDA-related matters that are changed shortly before an audit may give the appearance that the company knew there was a violation and fixed it.   And that may be ok, if your internal review process finds, for example, off-label content that needs to be corrected.   However, I would tend to leave things as they are unless you think the content needs to be corrected.    And while opinions may differ on this, I do not believe there is any first amendment right to prevent review of any materials that the FDA auditor or the company believes to be labeling.

Roger

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Roger Cepeda, Attorney
Health Sciences Law Group LLC
7670 N. Port Washington Rd., Ste. 201
Fox Point, WI 53217
Office: 414-206-2105
Mobile: 847-421-8361
Fax: 414-206-2109
Roger.Cepeda@HealthSciencesLawGroup.com
http://www.healthscienceslawgroup.com/
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Original Message:
Sent: 26-Dec-2017 01:49
From: Anonymous Member
Subject: FDA Audit Medical devices advertising

This message was posted by a user wishing to remain anonymous

​​Hi,

Based on the details shared in a related discussion, on this topic , is it advisable to alter the advertising material including website information before the audit, assuming FDA would have already accessed the same.

regards,

This just seems like you or your company is trying to hide something. If you're trying to correct labeling issues this large that it expands in websites, brochures, etc. I would follow your quality system and open a CAPA since this seems like a systemic issue. Figure out why there are issues (assuming there are) with the advertising; what is the true root cause. Is it lack of documentation of review or is it lack of knowledge, bad quality culture, marketing lives in a bubble, etc.

Most companies will have a review of advertising material or even press releases before it goes to public and that review is signed-off by regulatory, clinical, and marketing at a minimum and filed within document control. It's treated like another labeling material (ever see those alpha-numeric designations and sometimes revisions at the bottom footer of particular company pages? those are document control numbers, meaning they went through approval/review). If you don't treat websites and promotional/advertising materials this way, it will be very obvious to the FDA. I've had FDA come to me with print-outs of the website or a magazine that has a page that contain advertisement. If you're not already aware that they do review advert/promotion materials as labeling, please treat it as such now. Just look at all the warning letters on labeling or audit findings related to it that's been going on for years now. Admit to the issue and then fix it. FDA will be happier if you fix the problem you know now exist rather than try to hide it.

Good luck to you.

------------------------------
Clarisa Tate
VP, Product Development and Regulatory Affairs
Medical Devices Professional, RA/QA/Engineering
Bay Area, CA
USA
------------------------------

Original Message:
Sent: 26-Dec-2017 01:49
From: Anonymous Member
Subject: FDA Audit Medical devices advertising

This message was posted by a user wishing to remain anonymous

​​Hi,

Based on the details shared in a related discussion, on this topic , is it advisable to alter the advertising material including website information before the audit, assuming FDA would have already accessed the same.

regards,

Original Message------

This just seems like you or your company is trying to hide something. If you're trying to correct labeling issues this large that it expands in websites, brochures, etc. I would follow your quality system and open a CAPA since this seems like a systemic issue. Figure out why there are issues (assuming there are) with the advertising; what is the true root cause. Is it lack of documentation of review or is it lack of knowledge, bad quality culture, marketing lives in a bubble, etc.

Most companies will have a review of advertising material or even press releases before it goes to public and that review is signed-off by regulatory, clinical, and marketing at a minimum and filed within document control. It's treated like another labeling material (ever see those alpha-numeric designations and sometimes revisions at the bottom footer of particular company pages? those are document control numbers, meaning they went through approval/review). If you don't treat websites and promotional/advertising materials this way, it will be very obvious to the FDA. I've had FDA come to me with print-outs of the website or a magazine that has a page that contain advertisement. If you're not already aware that they do review advert/promotion materials as labeling, please treat it as such now. Just look at all the warning letters on labeling or audit findings related to it that's been going on for years now. Admit to the issue and then fix it. FDA will be happier if you fix the problem you know now exist rather than try to hide it.

Good luck to you.

------------------------------
Clarisa Tate
VP, Product Development and Regulatory Affairs
Medical Devices Professional, RA/QA/Engineering
Bay Area, CA
USA
------------------------------