Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,

I would like to learn what are the best practices which the Industry follows for the regulatory review of the medical device promotional material.
Is there a FDA guidance which I can follow?

Thanks!

For FDA, Internet/Social Media Platforms with Character Space Limitations- Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices and Presenting Risk Information in Prescription Drug and Medical Device Promotion are great places to start.

Something also to consider in the US, is the FTC. They aren't as involved in this sector as much as FDA but you'll want to make sure all claims are substantiated (with documentation) before any promotional material is released. 

RAPS also offers a book about this called Promotion of FDA-Regulated Medical Products (Hardcover)

None of these are have a step-by-step guidance or a flowchart of how to handle each piece of material but it at least gives you some criteria to build upon.

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Nicolas Garrett
Regulatory Affairs Associate
Norman OK
United States
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Original Message:
Sent: 12-Aug-2019 13:51
From: Anonymous Member
Subject: Medical device advertisement - Regulatory review of Promotional material

This message was posted by a user wishing to remain anonymous

Hi,

I would like to learn what are the best practices which the Industry follows for the regulatory review of the medical device promotional material.
Is there a FDA guidance which I can follow?

Thanks!

Just to follow on what Nicolas provided which is an excellent source - internally make sure you have a process defined for advertising approval.  We typically had a procedure describing quite similar to what is in the guidance document, what is allowed, not allowed, etc.  There was a form completed for the advertising or promotional material with the last approval being regulatory.  In a couple companies this was a very easy process, the Marketing person provided the promotional material, filled out the form, and signed.  Then me as the Regulatory person reviewed and approved.  Done.  It does not have to be complicated process, but definitely integrate into your quality system for a process like this.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 12-Aug-2019 17:57
From: Nicolas Garrett
Subject: Medical device advertisement - Regulatory review of Promotional material

For FDA, Internet/Social Media Platforms with Character Space Limitations- Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices and Presenting Risk Information in Prescription Drug and Medical Device Promotion are great places to start.

Something also to consider in the US, is the FTC. They aren't as involved in this sector as much as FDA but you'll want to make sure all claims are substantiated (with documentation) before any promotional material is released.

RAPS also offers a book about this called Promotion of FDA-Regulated Medical Products (Hardcover)

None of these are have a step-by-step guidance or a flowchart of how to handle each piece of material but it at least gives you some criteria to build upon.

------------------------------
Nicolas Garrett
Regulatory Affairs Associate
Norman OK
United States

Original Message:
Sent: 12-Aug-2019 13:51
From: Anonymous Member
Subject: Medical device advertisement - Regulatory review of Promotional material

This message was posted by a user wishing to remain anonymous

Hi,

I would like to learn what are the best practices which the Industry follows for the regulatory review of the medical device promotional material.
Is there a FDA guidance which I can follow?

Thanks!