Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello

I am new to website advertising and promotion review.  For a company product that is not approved in the US, but approved in other countries, can the US website have links that allow US customers to view the labeling, use video, or test performance of the company's approved product? Any other considerations?

The general rule of thumb is to be sure the ad/promo information for the uncleared/unapproved device has its own separate weblink and page(s) on the site, and that when clicking on the link, a warning message pop-up appears to remind visitors that they are about to view device information for a device not yet cleared/approved by the U.S. FDA.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 13-Jun-2022 09:15
From: Anonymous Member
Subject: US website links to unapproved product

This message was posted by a user wishing to remain anonymous

Hello

I am new to website advertising and promotion review.  For a company product that is not approved in the US, but approved in other countries, can the US website have links that allow US customers to view the labeling, use video, or test performance of the company's approved product? Any other considerations?

This message was posted by a user wishing to remain anonymous

Hello Mr. Randall, 
I would like to follow up on this question. Is there a clear requirement by FDA about separating content of the website geographically and making sure that intended use and indications for different countries are accessible only to users from that country?
Thanks for your input.
Best
Original Message:
Sent: 13-Jun-2022 11:59
From: Kevin Randall
Subject: US website links to unapproved product

The general rule of thumb is to be sure the ad/promo information for the uncleared/unapproved device has its own separate weblink and page(s) on the site, and that when clicking on the link, a warning message pop-up appears to remind visitors that they are about to view device information for a device not yet cleared/approved by the U.S. FDA.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 13-Jun-2022 09:15
From: Anonymous Member
Subject: US website links to unapproved product

This message was posted by a user wishing to remain anonymous

Hello

I am new to website advertising and promotion review.  For a company product that is not approved in the US, but approved in other countries, can the US website have links that allow US customers to view the labeling, use video, or test performance of the company's approved product? Any other considerations?

Great question; thanks for circling back.

FDA's approach to regulating website representations of a subject device that isn't cleared, approved, or otherwise legally marketed for the U.S. jurisdiction, is governed by U.S. medical device misbranding law. Specifically, the misbranding provision at section 502 of the FD&C Act (U.S.C. section 352) stating that a device is deemed to be misbranded if its labeling is false or misleading in any particular.  A website is considered by FDA to be labeling.

Yet I know of no FDA law or regulation that specifically/directly prescribes how we must design our websites for compliance with section 502.  But we could probably find corresponding FDA guidance on the matter which would echo general "rules of thumb" like that which I mentioned before, and/or emphasizing that ultimately, whatever labeling solution you choose, such solution must result in a device whose risk is within corresponding risk acceptance criteria prescribed in the device's Risk Management Plan.

In practice, FDA would generally look for greater website risk controls regarding a higher risk-class device than for a lower risk-class device.  If it is reasonably foreseeable that the safety of the U.S. use of the subject device could be undermined by your website's accessibility to a version of the device that has different intended use / indications for different jurisdictions, then corresponding website risk controls are needed commensurate with the risk.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 29-Nov-2022 11:16
From: Anonymous Member
Subject: US website links to unapproved product

This message was posted by a user wishing to remain anonymous

Hello Mr. Randall,
I would like to follow up on this question. Is there a clear requirement by FDA about separating content of the website geographically and making sure that intended use and indications for different countries are accessible only to users from that country?
Thanks for your input.
Best
Original Message:
Sent: 13-Jun-2022 11:59
From: Kevin Randall
Subject: US website links to unapproved product

The general rule of thumb is to be sure the ad/promo information for the uncleared/unapproved device has its own separate weblink and page(s) on the site, and that when clicking on the link, a warning message pop-up appears to remind visitors that they are about to view device information for a device not yet cleared/approved by the U.S. FDA.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 13-Jun-2022 09:15
From: Anonymous Member
Subject: US website links to unapproved product

This message was posted by a user wishing to remain anonymous

Hello

I am new to website advertising and promotion review.  For a company product that is not approved in the US, but approved in other countries, can the US website have links that allow US customers to view the labeling, use video, or test performance of the company's approved product? Any other considerations?

Forgot to mention the additional insights given by section 201(n) of the Act.  It (my paraphrase) says that, if an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is actually misleading, there shall be taken into account (among other things) not only representations made or suggested by statement, word, design [e.g., website design], device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations...[emphasis added].

This legal parameter should be given careful consideration when deciding specifically how you will design your website risk controls (e.g., via different webpage address vs. the same webpage; pop-up warning windows vs. fine-print disclaimers on the same all-inclusive page, etc., etc.).

Please note also that this is not meant to be legal advice for your particular scenario.  For such legal advice, you need to consult with qualified legal counsel.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 29-Nov-2022 13:46
From: Kevin Randall
Subject: US website links to unapproved product

Great question; thanks for circling back.

FDA's approach to regulating website representations of a subject device that isn't cleared, approved, or otherwise legally marketed for the U.S. jurisdiction, is governed by U.S. medical device misbranding law. Specifically, the misbranding provision at section 502 of the FD&C Act (U.S.C. section 352) stating that a device is deemed to be misbranded if its labeling is false or misleading in any particular.  A website is considered by FDA to be labeling.

Yet I know of no FDA law or regulation that specifically/directly prescribes how we must design our websites for compliance with section 502.  But we could probably find corresponding FDA guidance on the matter which would echo general "rules of thumb" like that which I mentioned before, and/or emphasizing that ultimately, whatever labeling solution you choose, such solution must result in a device whose risk is within corresponding risk acceptance criteria prescribed in the device's Risk Management Plan.

In practice, FDA would generally look for greater website risk controls regarding a higher risk-class device than for a lower risk-class device.  If it is reasonably foreseeable that the safety of the U.S. use of the subject device could be undermined by your website's accessibility to a version of the device that has different intended use / indications for different jurisdictions, then corresponding website risk controls are needed commensurate with the risk.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 29-Nov-2022 11:16
From: Anonymous Member
Subject: US website links to unapproved product

This message was posted by a user wishing to remain anonymous

Hello Mr. Randall,
I would like to follow up on this question. Is there a clear requirement by FDA about separating content of the website geographically and making sure that intended use and indications for different countries are accessible only to users from that country?
Thanks for your input.
Best
Original Message:
Sent: 13-Jun-2022 11:59
From: Kevin Randall
Subject: US website links to unapproved product

The general rule of thumb is to be sure the ad/promo information for the uncleared/unapproved device has its own separate weblink and page(s) on the site, and that when clicking on the link, a warning message pop-up appears to remind visitors that they are about to view device information for a device not yet cleared/approved by the U.S. FDA.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 13-Jun-2022 09:15
From: Anonymous Member
Subject: US website links to unapproved product

This message was posted by a user wishing to remain anonymous

Hello

I am new to website advertising and promotion review.  For a company product that is not approved in the US, but approved in other countries, can the US website have links that allow US customers to view the labeling, use video, or test performance of the company's approved product? Any other considerations?

The way an FDA auditor explained this to me was labels for uncleared/approved by FDA may not interfere with the health choices of any patient, either perceived or real possible treatment. If a patient has a disease and sees an ad for a non FDA approved mitigation, that could influence their treatment decision process in a harmful way, either delaying proper treatment or waiting for a better treatment.

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 13-Jun-2022 09:15
From: Anonymous Member
Subject: US website links to unapproved product

This message was posted by a user wishing to remain anonymous

Hello

I am new to website advertising and promotion review.  For a company product that is not approved in the US, but approved in other countries, can the US website have links that allow US customers to view the labeling, use video, or test performance of the company's approved product? Any other considerations?

This message was posted by a user wishing to remain anonymous

Thank you both!
Original Message:
Sent: 29-Nov-2022 14:45
From: Ed Panek
Subject: US website links to unapproved product

The way an FDA auditor explained this to me was labels for uncleared/approved by FDA may not interfere with the health choices of any patient, either perceived or real possible treatment. If a patient has a disease and sees an ad for a non FDA approved mitigation, that could influence their treatment decision process in a harmful way, either delaying proper treatment or waiting for a better treatment.

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 13-Jun-2022 09:15
From: Anonymous Member
Subject: US website links to unapproved product

This message was posted by a user wishing to remain anonymous

Hello

I am new to website advertising and promotion review.  For a company product that is not approved in the US, but approved in other countries, can the US website have links that allow US customers to view the labeling, use video, or test performance of the company's approved product? Any other considerations?

Very well put Ed!

------------------------------
Beth Foster
Principle Regulatory Affairs Associate
Margate FL
United States
------------------------------

Original Message:
Sent: 29-Nov-2022 14:45
From: Ed Panek
Subject: US website links to unapproved product

The way an FDA auditor explained this to me was labels for uncleared/approved by FDA may not interfere with the health choices of any patient, either perceived or real possible treatment. If a patient has a disease and sees an ad for a non FDA approved mitigation, that could influence their treatment decision process in a harmful way, either delaying proper treatment or waiting for a better treatment.

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 13-Jun-2022 09:15
From: Anonymous Member
Subject: US website links to unapproved product

This message was posted by a user wishing to remain anonymous

Hello

I am new to website advertising and promotion review.  For a company product that is not approved in the US, but approved in other countries, can the US website have links that allow US customers to view the labeling, use video, or test performance of the company's approved product? Any other considerations?

I'm late to this conversation, but it wasn't clear to me whether the question was regarding a drug versus a device, as FDA enforcement is higher on the pharma side.   If someone is new to ad/prom, I often try to find a warning letter that is close to their scenario, and I would suggest that here.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters

At that free site, you can enter "website" under Search and get the total list of website-related warning letters, and then add, under Filter, the FDA office that corresponds to your area, such as typing in "center for devices" under "Issuing Office" and you'll have a list of medical device related warning letters with website claims.   If it's a drug, change the word devices to drugs so the filter reads "center for drugs" and you'll have the analogous list for drug website enforcement.    

You'll see the same laws that Kevin described in his answers, except that you'll have them applied to a specific situation in context, rather than in the abstract.

Roger


------------------------------
Roger Cepeda, JD, MBA, RAC
MedTech Law LLC
roger@medtech.law
Mobile: 847-421-8361
------------------------------

Original Message:
Sent: 13-Jun-2022 09:15
From: Anonymous Member
Subject: US website links to unapproved product

This message was posted by a user wishing to remain anonymous

Hello

I am new to website advertising and promotion review.  For a company product that is not approved in the US, but approved in other countries, can the US website have links that allow US customers to view the labeling, use video, or test performance of the company's approved product? Any other considerations?