Regulatory Open Forum

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Annemarie   
Regulatory Affairs Project Manager
United States
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There was a qualified regulatory consultant that told us if the following statement was added to the US promotional materials for an upcoming product that does NOT have clearance, the promotional materials would not be considered false claims/misbranding:

'*Not to be distributed in the United States.'

This seems to oppose everything I know about false claims, but the person comes highly qualified and my company would like to be able to follow this (of course).  Has anyone else heard of this as being acceptable?

Thanks.  I am looking for more than my own interpretation and understanding of the regulations to provide my executive management.

Annemarie,

For FDA to determine whether the device is misbranded (for example, in response to consumer/competitors' complaints), they review everything available. 

Although it is best not to promote unapproved/uncleared devices, you may recommend the following to your management if they insist. 

"This device is not available in the US.  This is for demo purposes only."

If your device is available in EU, then you may state:

"This device is only available in EU.  This is for demo purposes only."


Original Message:
Sent: 03-12-2015 21:40
From: Annemarie Erickson
Subject: qualifying statement for pre-clearance promotion



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Annemarie   
Regulatory Affairs Project Manager
United States
-------------------------------------------

There was a qualified regulatory consultant that told us if the following statement was added to the US promotional materials for an upcoming product that does NOT have clearance, the promotional materials would not be considered false claims/misbranding:

'*Not to be distributed in the United States.'

This seems to oppose everything I know about false claims, but the person comes highly qualified and my company would like to be able to follow this (of course).  Has anyone else heard of this as being acceptable?

Thanks.  I am looking for more than my own interpretation and understanding of the regulations to provide my executive management.

Hi Annemarie, Difficult to answer without more details. Are the materials to be distributed at a U.S. trade show or a trade show that may have US attendees although it is being conducted outside of the U.S.? Is the product currently available outside of the U.S.? The statement provided is not adequate with the brief description in your message. There is other text depending on the stage of development that the medical device is at or whether the 510(k) submission is pending and if these materials are to be shown at a trade show. Carol ------------------------------------------- Carol Cooper RAC CM Cooper & Associates Libertyville IL United States -------------------------------------------
Original Message: Sent: 03-12-2015 21:40 From: Annemarie Erickson Subject: qualifying statement for pre-clearance promotion ------------------------------------------- Annemarie Regulatory Affairs Project Manager United States ------------------------------------------- There was a qualified regulatory consultant that told us if the following statement was added to the US promotional materials for an upcoming product that does NOT have clearance, the promotional materials would not be considered false claims/misbranding: '*Not to be distributed in the United States.' This seems to oppose everything I know about false claims, but the person comes highly qualified and my company would like to be able to follow this (of course). Has anyone else heard of this as being acceptable? Thanks. I am looking for more than my own interpretation and understanding of the regulations to provide my executive management.

In fact, there is an FDA compliance guide (FDA guide) available concerning "commercial distribution" for a pending 510(k) since 1978, the FDA guide of which is still valid and effective.   

Please refer to http://wp.me/P4xpOK-RC

Note: statements (as part of labeling) should be carefully considered before, during, or after device clearances/approvals.  

Original Message:
Sent: 03-12-2015 21:40
From: Annemarie Erickson
Subject: qualifying statement for pre-clearance promotion



-------------------------------------------
Annemarie   
Regulatory Affairs Project Manager
United States
-------------------------------------------

There was a qualified regulatory consultant that told us if the following statement was added to the US promotional materials for an upcoming product that does NOT have clearance, the promotional materials would not be considered false claims/misbranding:

'*Not to be distributed in the United States.'

This seems to oppose everything I know about false claims, but the person comes highly qualified and my company would like to be able to follow this (of course).  Has anyone else heard of this as being acceptable?

Thanks.  I am looking for more than my own interpretation and understanding of the regulations to provide my executive management.

With regard to false claims...  You will also need to consider that because FDA hasn't yet cleared the device, the claims and indications are still not known.  Therefore, you can't make clinical or performance claims regarding the device prior to clearance.  So, you could have a "coming soon" type ad that just identifies the product and indicates that its "pending FDA 510(k) clearance".  However, you shouldn't include any product claims or indications until you obtain FDA clearance...

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Brian Young RAC
Principal and Chief Regulator Consultant
Parenteau Bioconsultants LLC
Boerne TX
United States
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Original Message:
Sent: 03-14-2015 11:22
From: David Lim
Subject: qualifying statement for pre-clearance promotion

In fact, there is an FDA compliance guide (FDA guide) available concerning "commercial distribution" for a pending 510(k) since 1978, the FDA guide of which is still valid and effective.   

Please refer to http://wp.me/P4xpOK-RC

Note: statements (as part of labeling) should be carefully considered before, during, or after device clearances/approvals.  

Original Message:
Sent: 03-12-2015 21:40
From: Annemarie Erickson
Subject: qualifying statement for pre-clearance promotion



-------------------------------------------
Annemarie   
Regulatory Affairs Project Manager
United States
-------------------------------------------

There was a qualified regulatory consultant that told us if the following statement was added to the US promotional materials for an upcoming product that does NOT have clearance, the promotional materials would not be considered false claims/misbranding:

'*Not to be distributed in the United States.'

This seems to oppose everything I know about false claims, but the person comes highly qualified and my company would like to be able to follow this (of course).  Has anyone else heard of this as being acceptable?

Thanks.  I am looking for more than my own interpretation and understanding of the regulations to provide my executive management.