Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Seeking advice regarding whether marketing and advertising development would fall under FDA QS design controls.   Do medical device companies process all marketing materials through the design control process or are there exceptions?

thanks for your help

mike

Hello Mike,

In my experience, development of marketing and advertising material often occurs parallel to design controls handled by Sale and/or Marketing.  Now being a quality/regulatory professional I would want to see it as part of the design control process, but often is not the case.  Depending on the design control process this can occur in development.  As an example I have used in the past, as a deliverable in the Design Review sometime prior to launch, there can be a review of marketing materials to ensure these are aligned to the design activities; usually still early enough to make changes as needed prior to publication of marketing brochures since many are distributed electronic now.  However, marketing and advertising should at least go through a minimum review and approval process prior to publication of brochures, websites, patient pamphlets, etc.  This review would ensure statements, claims, and technical information is indeed reviewed against the development work such as product requirement documents or technical specifications to ensure correct and accurate statements are being made.  This should occur through the life cycle of the device, not just during or at end of design control process.  I would not say there is a specific requirement or exception to this, more about how a company implements their design control process including this activity or not.  Marketing and advertising materials are reviewed by regulatory agencies, so again make sure this goes through some type of review and approval process.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 12-May-2021 14:53
From: Anonymous Member
Subject: FDA Design Controls and Promo/Advertising Materials

This message was posted by a user wishing to remain anonymous

Seeking advice regarding whether marketing and advertising development would fall under FDA QS design controls.   Do medical device companies process all marketing materials through the design control process or are there exceptions?

thanks for your help

mike

To add to Richard's comment, I recommend that all marketing materials be managed under the document control process to ensure that all revisions get suitable review and inventory control.  Additionally purchasing controls need to assure only approved versions are ordered and distributed  

I have seen cases where marketing materials are not under any kind of control and the warehouse had several different versions on the shelf and no instructions were present about which version should be distributed, so all were considered equivalent and anyone could be distributed with the device or in response to requests for literature. 

------------------------------
Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
Principal Consultant
Edwin Bills Consultant
Overland Park KS
United States
elb@edwinbillsconsultant.com
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Original Message:
Sent: 13-May-2021 01:26
From: Richard Vincins
Subject: FDA Design Controls and Promo/Advertising Materials

Hello Mike,

In my experience, development of marketing and advertising material often occurs parallel to design controls handled by Sale and/or Marketing.  Now being a quality/regulatory professional I would want to see it as part of the design control process, but often is not the case.  Depending on the design control process this can occur in development.  As an example I have used in the past, as a deliverable in the Design Review sometime prior to launch, there can be a review of marketing materials to ensure these are aligned to the design activities; usually still early enough to make changes as needed prior to publication of marketing brochures since many are distributed electronic now.  However, marketing and advertising should at least go through a minimum review and approval process prior to publication of brochures, websites, patient pamphlets, etc.  This review would ensure statements, claims, and technical information is indeed reviewed against the development work such as product requirement documents or technical specifications to ensure correct and accurate statements are being made.  This should occur through the life cycle of the device, not just during or at end of design control process.  I would not say there is a specific requirement or exception to this, more about how a company implements their design control process including this activity or not.  Marketing and advertising materials are reviewed by regulatory agencies, so again make sure this goes through some type of review and approval process.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE

Original Message:
Sent: 12-May-2021 14:53
From: Anonymous Member
Subject: FDA Design Controls and Promo/Advertising Materials

This message was posted by a user wishing to remain anonymous

Seeking advice regarding whether marketing and advertising development would fall under FDA QS design controls.   Do medical device companies process all marketing materials through the design control process or are there exceptions?

thanks for your help

mike

Great question.  This is definitely a topic about which there often seems to be various opinions, recommendations, suggestions, etc., where such interpretive variability can lead to compliance problems.  But in FDA's eyes, the issue and associated requirements are abundantly clear.  Specifically, FDA officially considers ad/promo materials to be labeling.  And by FDA definition, labeling is part of the total finished design output.  And where there's design output, there must also be corresponding design planning, inputs, verification, validation, transfer, and design change control.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 12-May-2021 14:53
From: Anonymous Member
Subject: FDA Design Controls and Promo/Advertising Materials

This message was posted by a user wishing to remain anonymous

Seeking advice regarding whether marketing and advertising development would fall under FDA QS design controls.   Do medical device companies process all marketing materials through the design control process or are there exceptions?

thanks for your help

mike

Hi Mike, I want to add on to the other comments:

Make sure that whatever document control system you use covers all types of labeling. It includes not just printed labeling but also labeling on website and translations, etc. I've seen a situation where, because the process wasn't very well controlled, there were 3 different revisions of the same package insert being used concurrently. The physical one packaged in the box was the correct revision. The PDFs on the website (both English and the global translations ones) were older revisions (and not even the same older revision). The document control process did not account for updating the labeling content posted on the website, so those lagged and were only updated if caught manually.

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

Original Message:
Sent: 12-May-2021 14:53
From: Anonymous Member
Subject: FDA Design Controls and Promo/Advertising Materials

This message was posted by a user wishing to remain anonymous

Seeking advice regarding whether marketing and advertising development would fall under FDA QS design controls.   Do medical device companies process all marketing materials through the design control process or are there exceptions?

thanks for your help

mike