Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello All,

For 510k, De Novo, and PMA, do you typically include advertising and promotional material in your Proposed Labeling section, meaning brochures, website screenshots, etc?

Your question is an interesting one because it identifies a big difference between device and drug/biologic regulation.  Drugs and biologics have specific regulations on promotional materials (21 CFR 202.1); however, medical devices do not.  While you can submit all of those materials in the files you identify, unless you have been specifically requested to do so, it is not required.  In fact, CDRH has very few staff focused on promotional materials - unlike CBER and CDER who have entire Branches/Offices dedicated to promotional regulation oversight.

That being said, what you claim in brochures, websites and other promotional materials need to be consistent with the intended use of your device.   If you are not careful and either directly or in some implied way infer a new intended use inconsistent with your approval/clearance, then FDA can make a determination that your promotion creates a new intended use for your device and that would be a problem (i.e., misbrands your device).

My personal recommendation is NOT to submit such materials unless you have a specific request from the Agency to do so.

Sincerely,
Glenn Byrd

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Glenn Byrd, MBA
President, GByrd Ad-Promo Solutions, LLC
President, RAPS Board of Directors
United States
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Original Message:
Sent: 20-Nov-2020 14:43
From: Anonymous Member
Subject: Advertising/promotional material review by FDA

This message was posted by a user wishing to remain anonymous

Hello All,

For 510k, De Novo, and PMA, do you typically include advertising and promotional material in your Proposed Labeling section, meaning brochures, website screenshots, etc?

This message was posted by a user wishing to remain anonymous

I have a question on promotional material control. Is there any guidance on promotional material control mainly website and social media. Do you have recommendation on setting up the Promotional Material control Procedure for a startup that is entering market in EU and in process of getting their 510k clearance? Any suggestion or recommendation is welcome.
Original Message:
Sent: 21-Nov-2020 08:00
From: Glenn Byrd
Subject: Advertising/promotional material review by FDA

Your question is an interesting one because it identifies a big difference between device and drug/biologic regulation.  Drugs and biologics have specific regulations on promotional materials (21 CFR 202.1); however, medical devices do not.  While you can submit all of those materials in the files you identify, unless you have been specifically requested to do so, it is not required.  In fact, CDRH has very few staff focused on promotional materials - unlike CBER and CDER who have entire Branches/Offices dedicated to promotional regulation oversight.

That being said, what you claim in brochures, websites and other promotional materials need to be consistent with the intended use of your device.   If you are not careful and either directly or in some implied way infer a new intended use inconsistent with your approval/clearance, then FDA can make a determination that your promotion creates a new intended use for your device and that would be a problem (i.e., misbrands your device).

My personal recommendation is NOT to submit such materials unless you have a specific request from the Agency to do so.

Sincerely,
Glenn Byrd

------------------------------
Glenn Byrd, MBA
President, GByrd Ad-Promo Solutions, LLC
President, RAPS Board of Directors
United States

Original Message:
Sent: 20-Nov-2020 14:43
From: Anonymous Member
Subject: Advertising/promotional material review by FDA

This message was posted by a user wishing to remain anonymous

Hello All,

For 510k, De Novo, and PMA, do you typically include advertising and promotional material in your Proposed Labeling section, meaning brochures, website screenshots, etc?

The PMA guidance lists advertising material as a section to be included, and I have sometimes had FDA ask for it, but generally we just include a draft product brochure, not all of our advertising. The CFR does list it as a PMA section, but gives absolutely no guidance as to what exactly that means, so this seems to address it without getting into trying to include all your launch materials (which you likely don't even have that far ahead of a launch).

You can also state "materials are not yet available" in that section, and it will get through filing review, but you do sometimes get a request for it later.

I never include A&P info in a 510(k) unless it is somehow needed to establish substantial equivalence or it is needed to show there isn't a "stealth" indication you are planning to promote.

g-

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

Original Message:
Sent: 20-Nov-2020 14:43
From: Anonymous Member
Subject: Advertising/promotional material review by FDA

This message was posted by a user wishing to remain anonymous

Hello All,

For 510k, De Novo, and PMA, do you typically include advertising and promotional material in your Proposed Labeling section, meaning brochures, website screenshots, etc?