Regulatory Open Forum

Hi,

Does anyone have any ideas on how to manage changes on your website?  Currently, we digitize every webpage, radio button selection etc, and route it through the ECO process.  As the website becomes more complex and savvy, this gets increasingly difficult.  A change to a single page, could be a 55 page screen shot.  

How are others managing reviewing, approving and documenting changes to the content on your website?

Thanks,
Jessica

------------------------------
Jessica Staub
Thorndale PA
United States
------------------------------

HI there, 

My experience has been that it's the  content of the material posted on the website that is strictly controlled. Advertising/promotional material requires a regulatory review before implementing the changes in the QMS. ECO changes are more applicable to technical documents such as DHFs, DMRs and other engineering documents. Changes to a website can fall under general change management  (e.g. a Document Change Notification or DCN). You can put a box on the change control form for the section related to website material and check it off any time you are making a change to website content related to advertising and/or promotion.  Hope it helps.

------------------------------
Karen Zhou
------------------------------

Original Message:
Sent: 28-Feb-2019 13:13
From: Jessica Staub
Subject: Website Change Control

Hi,

Does anyone have any ideas on how to manage changes on your website?  Currently, we digitize every webpage, radio button selection etc, and route it through the ECO process.  As the website becomes more complex and savvy, this gets increasingly difficult.  A change to a single page, could be a 55 page screen shot.

How are others managing reviewing, approving and documenting changes to the content on your website?

Thanks,
Jessica

------------------------------
Jessica Staub
Thorndale PA
United States
------------------------------

Karen is right (doesn't really matter if you call it ECN or DCN so long as it's controlled - if it has technical information, have the engineering team sign off). Just don't forget that pictures, videos, sound bytes, can also count as "content." It is also important that you use these as guidances:

https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm401087.pdf
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm155480.pdf

------------------------------
Clarisa Tate
VP, Product Development and Regulatory Affairs
Medical Devices Professional, RA/QA/Engineering
Bay Area, CA
USA
------------------------------

Original Message:
Sent: 28-Feb-2019 13:46
From: Karen Zhou
Subject: Website Change Control

HI there,

My experience has been that it's the  content of the material posted on the website that is strictly controlled. Advertising/promotional material requires a regulatory review before implementing the changes in the QMS. ECO changes are more applicable to technical documents such as DHFs, DMRs and other engineering documents. Changes to a website can fall under general change management  (e.g. a Document Change Notification or DCN). You can put a box on the change control form for the section related to website material and check it off any time you are making a change to website content related to advertising and/or promotion.  Hope it helps.

------------------------------
Karen Zhou

Original Message:
Sent: 28-Feb-2019 13:13
From: Jessica Staub
Subject: Website Change Control

Hi,

Does anyone have any ideas on how to manage changes on your website?  Currently, we digitize every webpage, radio button selection etc, and route it through the ECO process.  As the website becomes more complex and savvy, this gets increasingly difficult.  A change to a single page, could be a 55 page screen shot.

How are others managing reviewing, approving and documenting changes to the content on your website?

Thanks,
Jessica

------------------------------
Jessica Staub
Thorndale PA
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Interesting discussion.  I'm fairly new to regulatory, and in a small company.  I respect Karen and Julie's input, but where I work the Marketing Dept. believes the website, and marketing materials in general, are outside the "quality system" and therefore not subject to regulatory review.  Frankly, they prefer not to have the Regulatory folks involved.  Can someone point to an authoritative source that says marketing materials require regulatory review?  I've made the argument that these are all labeling, but with no real success.  Is it common that Marketing (as opposed to the Regulatory Dept.) is responsible for regulatory review of marketing materials?  It's fair to assume there is no one in Marketing at this location with a regulatory background.

Thanks to all.

Original Message:
Sent: 28-Feb-2019 13:46
From: Karen Zhou
Subject: Website Change Control

HI there,

My experience has been that it's the  content of the material posted on the website that is strictly controlled. Advertising/promotional material requires a regulatory review before implementing the changes in the QMS. ECO changes are more applicable to technical documents such as DHFs, DMRs and other engineering documents. Changes to a website can fall under general change management  (e.g. a Document Change Notification or DCN). You can put a box on the change control form for the section related to website material and check it off any time you are making a change to website content related to advertising and/or promotion.  Hope it helps.

------------------------------
Karen Zhou

Original Message:
Sent: 28-Feb-2019 13:13
From: Jessica Staub
Subject: Website Change Control

Hi,

Does anyone have any ideas on how to manage changes on your website?  Currently, we digitize every webpage, radio button selection etc, and route it through the ECO process.  As the website becomes more complex and savvy, this gets increasingly difficult.  A change to a single page, could be a 55 page screen shot.

How are others managing reviewing, approving and documenting changes to the content on your website?

Thanks,
Jessica

------------------------------
Jessica Staub
Thorndale PA
United States
------------------------------

I'm not aware of any source, authoritative or otherwise, that says ANYTHING requires Regulatory review, including the quality system.

Decide how far you are comfortable pushing this.  Even in a small company, somewhere up the reporting structure, both RA and Marketing report to someone.  THAT is the person who should make this call, not Marketing, not you. Take the issue to them (or to whomever you report to that reports to them).

Provide them with the definition of "labeling" for the applicable jurisdiction(s) (US, EU).  Some folks here keep a close eye on warning letters; they may be able to provide you with a couple that cite website promotions. (Ideally from the same industry...pharma, devices, food).  ASK if they would like you to review website content for regulatory compliance. If they say no, make sure you document their lack of interest.  Then your job is done.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 01-Mar-2019 18:26
From: Anonymous Member
Subject: Website Change Control

This message was posted by a user wishing to remain anonymous

Interesting discussion.  I'm fairly new to regulatory, and in a small company.  I respect Karen and Julie's input, but where I work the Marketing Dept. believes the website, and marketing materials in general, are outside the "quality system" and therefore not subject to regulatory review.  Frankly, they prefer not to have the Regulatory folks involved.  Can someone point to an authoritative source that says marketing materials require regulatory review?  I've made the argument that these are all labeling, but with no real success.  Is it common that Marketing (as opposed to the Regulatory Dept.) is responsible for regulatory review of marketing materials?  It's fair to assume there is no one in Marketing at this location with a regulatory background.

Thanks to all.

Original Message:
Sent: 28-Feb-2019 13:46
From: Karen Zhou
Subject: Website Change Control

HI there,

My experience has been that it's the  content of the material posted on the website that is strictly controlled. Advertising/promotional material requires a regulatory review before implementing the changes in the QMS. ECO changes are more applicable to technical documents such as DHFs, DMRs and other engineering documents. Changes to a website can fall under general change management  (e.g. a Document Change Notification or DCN). You can put a box on the change control form for the section related to website material and check it off any time you are making a change to website content related to advertising and/or promotion.  Hope it helps.

------------------------------
Karen Zhou

Original Message:
Sent: 28-Feb-2019 13:13
From: Jessica Staub
Subject: Website Change Control

Hi,

Does anyone have any ideas on how to manage changes on your website?  Currently, we digitize every webpage, radio button selection etc, and route it through the ECO process.  As the website becomes more complex and savvy, this gets increasingly difficult.  A change to a single page, could be a 55 page screen shot.

How are others managing reviewing, approving and documenting changes to the content on your website?

Thanks,
Jessica

------------------------------
Jessica Staub
Thorndale PA
United States
------------------------------
​

This message was posted by a user wishing to remain anonymous

​Great advice Julie.  Thanks.
Original Message:
Sent: 04-Mar-2019 09:29
From: Julie Omohundro
Subject: Website Change Control

I'm not aware of any source, authoritative or otherwise, that says ANYTHING requires Regulatory review, including the quality system.

Decide how far you are comfortable pushing this.  Even in a small company, somewhere up the reporting structure, both RA and Marketing report to someone.  THAT is the person who should make this call, not Marketing, not you. Take the issue to them (or to whomever you report to that reports to them).

Provide them with the definition of "labeling" for the applicable jurisdiction(s) (US, EU).  Some folks here keep a close eye on warning letters; they may be able to provide you with a couple that cite website promotions. (Ideally from the same industry...pharma, devices, food).  ASK if they would like you to review website content for regulatory compliance. If they say no, make sure you document their lack of interest.  Then your job is done.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 01-Mar-2019 18:26
From: Anonymous Member
Subject: Website Change Control

This message was posted by a user wishing to remain anonymous

Interesting discussion.  I'm fairly new to regulatory, and in a small company.  I respect Karen and Julie's input, but where I work the Marketing Dept. believes the website, and marketing materials in general, are outside the "quality system" and therefore not subject to regulatory review.  Frankly, they prefer not to have the Regulatory folks involved.  Can someone point to an authoritative source that says marketing materials require regulatory review?  I've made the argument that these are all labeling, but with no real success.  Is it common that Marketing (as opposed to the Regulatory Dept.) is responsible for regulatory review of marketing materials?  It's fair to assume there is no one in Marketing at this location with a regulatory background.

Thanks to all.

Original Message:
Sent: 28-Feb-2019 13:46
From: Karen Zhou
Subject: Website Change Control

HI there,

My experience has been that it's the  content of the material posted on the website that is strictly controlled. Advertising/promotional material requires a regulatory review before implementing the changes in the QMS. ECO changes are more applicable to technical documents such as DHFs, DMRs and other engineering documents. Changes to a website can fall under general change management  (e.g. a Document Change Notification or DCN). You can put a box on the change control form for the section related to website material and check it off any time you are making a change to website content related to advertising and/or promotion.  Hope it helps.

------------------------------
Karen Zhou

Original Message:
Sent: 28-Feb-2019 13:13
From: Jessica Staub
Subject: Website Change Control

Hi,

Does anyone have any ideas on how to manage changes on your website?  Currently, we digitize every webpage, radio button selection etc, and route it through the ECO process.  As the website becomes more complex and savvy, this gets increasingly difficult.  A change to a single page, could be a 55 page screen shot.

How are others managing reviewing, approving and documenting changes to the content on your website?

Thanks,
Jessica

------------------------------
Jessica Staub
Thorndale PA
United States
------------------------------
​

Certainly advertising and promotion are labeling, and this is clearly done on a website, hard copy brochures, etc. It is not outside of the Quality System, as it becomes a part of your Design History File for devices. It is retained for drugs and biologics. (Though unlike drugs/biologics, promotional advertising does not have to be cleared by FDA in advance for Class 1 and 2 devices thar I know of). 

It certainly has to be approved by FDA for drugs/biologics, via a promotional labeling submission.

While I agree there is no specific wording saying "RA" or "QA" has to review and approve promotional content, including website , most companies have that internal requirement to ensure laws, regulations, guidance regarding truthfulness, accuracy, fair balance are contained in it.  I have mostly seen only RA  and legal sign off, without QA signoff.   (QA did signoff on claims, since they were mostly based on bench testing)

At my last company, during review legal focused mostly on liability and FTC compliance while RA focused mostly on accuracy, claims support, and fair balance; but it was all reviewed with formal signoff. 

It would have the appearance of conflict of interest to most regulators if only marketing and business signed off on promotional pieces, including websites.  Just, as Julie says, look yourself at any website Warning Letters, or go to FDA DDMAC (for drugs) and look there.

Best regards,


------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 04-Mar-2019 09:29
From: Julie Omohundro
Subject: Website Change Control

I'm not aware of any source, authoritative or otherwise, that says ANYTHING requires Regulatory review, including the quality system.

Decide how far you are comfortable pushing this.  Even in a small company, somewhere up the reporting structure, both RA and Marketing report to someone.  THAT is the person who should make this call, not Marketing, not you. Take the issue to them (or to whomever you report to that reports to them).

Provide them with the definition of "labeling" for the applicable jurisdiction(s) (US, EU).  Some folks here keep a close eye on warning letters; they may be able to provide you with a couple that cite website promotions. (Ideally from the same industry...pharma, devices, food).  ASK if they would like you to review website content for regulatory compliance. If they say no, make sure you document their lack of interest.  Then your job is done.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com

Original Message:
Sent: 01-Mar-2019 18:26
From: Anonymous Member
Subject: Website Change Control

This message was posted by a user wishing to remain anonymous

Interesting discussion.  I'm fairly new to regulatory, and in a small company.  I respect Karen and Julie's input, but where I work the Marketing Dept. believes the website, and marketing materials in general, are outside the "quality system" and therefore not subject to regulatory review.  Frankly, they prefer not to have the Regulatory folks involved.  Can someone point to an authoritative source that says marketing materials require regulatory review?  I've made the argument that these are all labeling, but with no real success.  Is it common that Marketing (as opposed to the Regulatory Dept.) is responsible for regulatory review of marketing materials?  It's fair to assume there is no one in Marketing at this location with a regulatory background.

Thanks to all.

Original Message:
Sent: 28-Feb-2019 13:46
From: Karen Zhou
Subject: Website Change Control

HI there,

My experience has been that it's the  content of the material posted on the website that is strictly controlled. Advertising/promotional material requires a regulatory review before implementing the changes in the QMS. ECO changes are more applicable to technical documents such as DHFs, DMRs and other engineering documents. Changes to a website can fall under general change management  (e.g. a Document Change Notification or DCN). You can put a box on the change control form for the section related to website material and check it off any time you are making a change to website content related to advertising and/or promotion.  Hope it helps.

------------------------------
Karen Zhou

Original Message:
Sent: 28-Feb-2019 13:13
From: Jessica Staub
Subject: Website Change Control

Hi,

Does anyone have any ideas on how to manage changes on your website?  Currently, we digitize every webpage, radio button selection etc, and route it through the ECO process.  As the website becomes more complex and savvy, this gets increasingly difficult.  A change to a single page, could be a 55 page screen shot.

How are others managing reviewing, approving and documenting changes to the content on your website?

Thanks,
Jessica

------------------------------
Jessica Staub
Thorndale PA
United States
------------------------------
​

There is no explicit regulation that requires Regulatory review of marketing materials, or, for that matter, of many other documents. There is not, in fact, a requirement to have a Regulatory group or function. The reason most people do so is because it is a good business practice to have experts ensuring the company is no unwittingly violating regulations around labeling, intended use, FDA/FTC rules etc. This is because cleaning up after Warning Letters, Untitled Letters, Consent Decrees etc is a large resource suck that adds no value to your customers.

I have worked at organizations that at one time or another had no regulatory review of such documents, or had marketing/engineering determine when regulatory review was needed, and they typically ended up with a mess at the end. If there is a legal reviewer, they can sometimes be trained enough on the regulatory side to make such a system work, but usually these organizations don't have a legal reviewer either, because they either

1) are trying to get away with something and thus the review is a hindrance, or
2) have so little experience in a regulated industry that they actually don't know the problems they are creating

The best way to break through if no one is listening to you is to try and get them to attend an Ad/Promo conference or training somewhere. The old adage that "the outside expert is always deemed more credible than the inside expert" usually appears to be true.

g-

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

Original Message:
Sent: 01-Mar-2019 18:26
From: Anonymous Member
Subject: Website Change Control

This message was posted by a user wishing to remain anonymous

Interesting discussion.  I'm fairly new to regulatory, and in a small company.  I respect Karen and Julie's input, but where I work the Marketing Dept. believes the website, and marketing materials in general, are outside the "quality system" and therefore not subject to regulatory review.  Frankly, they prefer not to have the Regulatory folks involved.  Can someone point to an authoritative source that says marketing materials require regulatory review?  I've made the argument that these are all labeling, but with no real success.  Is it common that Marketing (as opposed to the Regulatory Dept.) is responsible for regulatory review of marketing materials?  It's fair to assume there is no one in Marketing at this location with a regulatory background.

Thanks to all.

Original Message:
Sent: 28-Feb-2019 13:46
From: Karen Zhou
Subject: Website Change Control

HI there,

My experience has been that it's the  content of the material posted on the website that is strictly controlled. Advertising/promotional material requires a regulatory review before implementing the changes in the QMS. ECO changes are more applicable to technical documents such as DHFs, DMRs and other engineering documents. Changes to a website can fall under general change management  (e.g. a Document Change Notification or DCN). You can put a box on the change control form for the section related to website material and check it off any time you are making a change to website content related to advertising and/or promotion.  Hope it helps.

------------------------------
Karen Zhou

Original Message:
Sent: 28-Feb-2019 13:13
From: Jessica Staub
Subject: Website Change Control

Hi,

Does anyone have any ideas on how to manage changes on your website?  Currently, we digitize every webpage, radio button selection etc, and route it through the ECO process.  As the website becomes more complex and savvy, this gets increasingly difficult.  A change to a single page, could be a 55 page screen shot.

How are others managing reviewing, approving and documenting changes to the content on your website?

Thanks,
Jessica

------------------------------
Jessica Staub
Thorndale PA
United States
------------------------------

100% agree but wanted to add that sometimes it is easier to bring the mountain to Mohammed.  You may be hard pressed to get them to attend training, but you may be able to bring some online training inhouse.​  Doesn't necessarily have to be a day-long workshop.   I've had success with some of the relatively inexpensive one-hour webinars.

It's an interesting psychology...although absolutely nobody in the company may be especially motivated about the matter, once everybody knows that everybody else knows, things sometimes change.  It's also a lot easier to get senior management to sit in on something relatively short and inhouse, and their mere presence can make a dent.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 05-Mar-2019 08:32
From: Ginger Glaser
Subject: Website Change Control

There is no explicit regulation that requires Regulatory review of marketing materials, or, for that matter, of many other documents. There is not, in fact, a requirement to have a Regulatory group or function. The reason most people do so is because it is a good business practice to have experts ensuring the company is no unwittingly violating regulations around labeling, intended use, FDA/FTC rules etc. This is because cleaning up after Warning Letters, Untitled Letters, Consent Decrees etc is a large resource suck that adds no value to your customers.

I have worked at organizations that at one time or another had no regulatory review of such documents, or had marketing/engineering determine when regulatory review was needed, and they typically ended up with a mess at the end. If there is a legal reviewer, they can sometimes be trained enough on the regulatory side to make such a system work, but usually these organizations don't have a legal reviewer either, because they either

1) are trying to get away with something and thus the review is a hindrance, or
2) have so little experience in a regulated industry that they actually don't know the problems they are creating

The best way to break through if no one is listening to you is to try and get them to attend an Ad/Promo conference or training somewhere. The old adage that "the outside expert is always deemed more credible than the inside expert" usually appears to be true.

g-

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

Original Message:
Sent: 01-Mar-2019 18:26
From: Anonymous Member
Subject: Website Change Control

This message was posted by a user wishing to remain anonymous

Interesting discussion.  I'm fairly new to regulatory, and in a small company.  I respect Karen and Julie's input, but where I work the Marketing Dept. believes the website, and marketing materials in general, are outside the "quality system" and therefore not subject to regulatory review.  Frankly, they prefer not to have the Regulatory folks involved.  Can someone point to an authoritative source that says marketing materials require regulatory review?  I've made the argument that these are all labeling, but with no real success.  Is it common that Marketing (as opposed to the Regulatory Dept.) is responsible for regulatory review of marketing materials?  It's fair to assume there is no one in Marketing at this location with a regulatory background.

Thanks to all.

Original Message:
Sent: 28-Feb-2019 13:46
From: Karen Zhou
Subject: Website Change Control

HI there,

My experience has been that it's the  content of the material posted on the website that is strictly controlled. Advertising/promotional material requires a regulatory review before implementing the changes in the QMS. ECO changes are more applicable to technical documents such as DHFs, DMRs and other engineering documents. Changes to a website can fall under general change management  (e.g. a Document Change Notification or DCN). You can put a box on the change control form for the section related to website material and check it off any time you are making a change to website content related to advertising and/or promotion.  Hope it helps.

------------------------------
Karen Zhou

Original Message:
Sent: 28-Feb-2019 13:13
From: Jessica Staub
Subject: Website Change Control

Hi,

Does anyone have any ideas on how to manage changes on your website?  Currently, we digitize every webpage, radio button selection etc, and route it through the ECO process.  As the website becomes more complex and savvy, this gets increasingly difficult.  A change to a single page, could be a 55 page screen shot.

How are others managing reviewing, approving and documenting changes to the content on your website?

Thanks,
Jessica

------------------------------
Jessica Staub
Thorndale PA
United States
------------------------------

Not sure if you are device or drugs but these are FDA links regarding device labeling requirements:

https://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/devicelabeling/default.htm. If you scroll to the middle of the first link it covers Advertising.




------------------------------
Susan Bush
CEO
Shamong NJ
United States
------------------------------

Original Message:
Sent: 01-Mar-2019 18:26
From: Anonymous Member
Subject: Website Change Control

This message was posted by a user wishing to remain anonymous

Interesting discussion.  I'm fairly new to regulatory, and in a small company.  I respect Karen and Julie's input, but where I work the Marketing Dept. believes the website, and marketing materials in general, are outside the "quality system" and therefore not subject to regulatory review.  Frankly, they prefer not to have the Regulatory folks involved.  Can someone point to an authoritative source that says marketing materials require regulatory review?  I've made the argument that these are all labeling, but with no real success.  Is it common that Marketing (as opposed to the Regulatory Dept.) is responsible for regulatory review of marketing materials?  It's fair to assume there is no one in Marketing at this location with a regulatory background.

Thanks to all.

Original Message:
Sent: 28-Feb-2019 13:46
From: Karen Zhou
Subject: Website Change Control

HI there,

My experience has been that it's the  content of the material posted on the website that is strictly controlled. Advertising/promotional material requires a regulatory review before implementing the changes in the QMS. ECO changes are more applicable to technical documents such as DHFs, DMRs and other engineering documents. Changes to a website can fall under general change management  (e.g. a Document Change Notification or DCN). You can put a box on the change control form for the section related to website material and check it off any time you are making a change to website content related to advertising and/or promotion.  Hope it helps.

------------------------------
Karen Zhou

Original Message:
Sent: 28-Feb-2019 13:13
From: Jessica Staub
Subject: Website Change Control

Hi,

Does anyone have any ideas on how to manage changes on your website?  Currently, we digitize every webpage, radio button selection etc, and route it through the ECO process.  As the website becomes more complex and savvy, this gets increasingly difficult.  A change to a single page, could be a 55 page screen shot.

How are others managing reviewing, approving and documenting changes to the content on your website?

Thanks,
Jessica

------------------------------
Jessica Staub
Thorndale PA
United States
------------------------------

TGA has an advertising code (Australia).

FDA has issue warning letters for claims outside of the ones reviewed during premarket submissions. This might be helpful to you.

------------------------------
Corey Jaseph RAC
Director of Regulatory Affairs
South Jordan UT
United States
------------------------------

Original Message:
Sent: 01-Mar-2019 18:26
From: Anonymous Member
Subject: Website Change Control

This message was posted by a user wishing to remain anonymous

Interesting discussion.  I'm fairly new to regulatory, and in a small company.  I respect Karen and Julie's input, but where I work the Marketing Dept. believes the website, and marketing materials in general, are outside the "quality system" and therefore not subject to regulatory review.  Frankly, they prefer not to have the Regulatory folks involved.  Can someone point to an authoritative source that says marketing materials require regulatory review?  I've made the argument that these are all labeling, but with no real success.  Is it common that Marketing (as opposed to the Regulatory Dept.) is responsible for regulatory review of marketing materials?  It's fair to assume there is no one in Marketing at this location with a regulatory background.

Thanks to all.

Original Message:
Sent: 28-Feb-2019 13:46
From: Karen Zhou
Subject: Website Change Control

HI there,

My experience has been that it's the  content of the material posted on the website that is strictly controlled. Advertising/promotional material requires a regulatory review before implementing the changes in the QMS. ECO changes are more applicable to technical documents such as DHFs, DMRs and other engineering documents. Changes to a website can fall under general change management  (e.g. a Document Change Notification or DCN). You can put a box on the change control form for the section related to website material and check it off any time you are making a change to website content related to advertising and/or promotion.  Hope it helps.

------------------------------
Karen Zhou

Original Message:
Sent: 28-Feb-2019 13:13
From: Jessica Staub
Subject: Website Change Control

Hi,

Does anyone have any ideas on how to manage changes on your website?  Currently, we digitize every webpage, radio button selection etc, and route it through the ECO process.  As the website becomes more complex and savvy, this gets increasingly difficult.  A change to a single page, could be a 55 page screen shot.

How are others managing reviewing, approving and documenting changes to the content on your website?

Thanks,
Jessica

------------------------------
Jessica Staub
Thorndale PA
United States
------------------------------

Read this: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/DeviceLabeling/ucm2005422.htm

"Most, if not all advertising, is labeling. The term 'labeling' is defined in the FFDCA as including all printed matter accompanying any article. Congress did not, and we cannot, exclude from the definition printed matter which constitutes advertising."

Kordel v. United States, 335 U. S. 345, 350 (1948):

• "accompanying such article" = includes any materials that supplement or explain an article
• Textual relationship that is significant
• No physical attachment to one another is necessary

So any product brochures, radio ad, tv ad, etc. that talks about product that is normally considered advertising is labeling. And now that we have websites and social media posts, that is labeling as well.

• Here's the Kim Kardashian promotional material warning letter due to her Social Media post extolling the virtues of a drug paid for by the company: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM457961.pdf
• Here are other warning letters for promotional material in 2015: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm432949.htm#OPDP
• Here are other warning letters of promotional material in 2016: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm482462.htm#OPDP
• Here's 2017: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm538552.htm#OPDP
• Here's 2018: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm594437.htm#OPDP

Here are the warning letters specific to medical devices. Unfortunately this isn't categorized as well as the drugs so you'll have to do your research yourself. https://www.accessdata.fda.gov/scripts/warningletters/wlSearchResult.cfm?office=Center%20for%20Devices%20and%20Radiological%20Health

In a different company many years ago, I once dodged a warning letter bullet on an advertising by showing how we have a process of controlling ALL marketing and sales materials through our document control process -- that we even have engineering sign off on technical portions. I was also supported by the FDA interview of the higher ups in marketing and sales that they are signers and that they even do their own change notices for promotional materials including website content. I've learned from that time that FDA can issue you a warning letter without stepping a foot into your facility. That they read the news about your product, that they are very specific with the wording regarding your claims and your product in ANY marketing/sales material, etc.

If you're in a company that doesn't do a regulatory review of labeling/promotional materials such as websites, news ad, etc. Then I sincerely hope you're not the highest ranking regulatory person because this issue has been a known issue since 1948 court ruling in drugs and about a decade in devices now. FDA won't give leeway anymore, they'll just think your regulatory higher up doesn't know what they are doing... good luck.

------------------------------
Clarisa Tate
VP, Product Development and Regulatory Affairs
Medical Devices Professional, RA/QA/Engineering
Bay Area, CA
USA
------------------------------

Original Message:
Sent: 01-Mar-2019 18:26
From: Anonymous Member
Subject: Website Change Control

This message was posted by a user wishing to remain anonymous

Interesting discussion.  I'm fairly new to regulatory, and in a small company.  I respect Karen and Julie's input, but where I work the Marketing Dept. believes the website, and marketing materials in general, are outside the "quality system" and therefore not subject to regulatory review.  Frankly, they prefer not to have the Regulatory folks involved.  Can someone point to an authoritative source that says marketing materials require regulatory review?  I've made the argument that these are all labeling, but with no real success.  Is it common that Marketing (as opposed to the Regulatory Dept.) is responsible for regulatory review of marketing materials?  It's fair to assume there is no one in Marketing at this location with a regulatory background.

Thanks to all.

Original Message:
Sent: 28-Feb-2019 13:46
From: Karen Zhou
Subject: Website Change Control

HI there,

My experience has been that it's the  content of the material posted on the website that is strictly controlled. Advertising/promotional material requires a regulatory review before implementing the changes in the QMS. ECO changes are more applicable to technical documents such as DHFs, DMRs and other engineering documents. Changes to a website can fall under general change management  (e.g. a Document Change Notification or DCN). You can put a box on the change control form for the section related to website material and check it off any time you are making a change to website content related to advertising and/or promotion.  Hope it helps.

------------------------------
Karen Zhou

Original Message:
Sent: 28-Feb-2019 13:13
From: Jessica Staub
Subject: Website Change Control

Hi,

Does anyone have any ideas on how to manage changes on your website?  Currently, we digitize every webpage, radio button selection etc, and route it through the ECO process.  As the website becomes more complex and savvy, this gets increasingly difficult.  A change to a single page, could be a 55 page screen shot.

How are others managing reviewing, approving and documenting changes to the content on your website?

Thanks,
Jessica

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Jessica Staub
Thorndale PA
United States
------------------------------

​I would agree with Karen.  I would look at this is a labeling change, not an engineering change, and therefore focus on the content of the website, rather than on the website itself.


------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 28-Feb-2019 13:13
From: Jessica Staub
Subject: Website Change Control

Hi,

Does anyone have any ideas on how to manage changes on your website?  Currently, we digitize every webpage, radio button selection etc, and route it through the ECO process.  As the website becomes more complex and savvy, this gets increasingly difficult.  A change to a single page, could be a 55 page screen shot.

How are others managing reviewing, approving and documenting changes to the content on your website?

Thanks,
Jessica

------------------------------
Jessica Staub
Thorndale PA
United States
------------------------------

Hi, My company is quite small,  but we manage our website changes though our promotional review committee. The PRC process documents what the change is, the pages it impacts, and has the records of approvals. We do use an agency to do the actual changes, but we control the content and the submission for FDA-OPDP.

Hope this helps.

------------------------------
Susan Shockey RAC
Regulatory Affairs and Quality Management
Charleston SC
United States
------------------------------

Original Message:
Sent: 28-Feb-2019 13:13
From: Jessica Staub
Subject: Website Change Control

Hi,

Does anyone have any ideas on how to manage changes on your website?  Currently, we digitize every webpage, radio button selection etc, and route it through the ECO process.  As the website becomes more complex and savvy, this gets increasingly difficult.  A change to a single page, could be a 55 page screen shot.

How are others managing reviewing, approving and documenting changes to the content on your website?

Thanks,
Jessica

------------------------------
Jessica Staub
Thorndale PA
United States
------------------------------