Control of Promotional/Advertising Materials

tebusse

Involved In Discussions
Greetings,

I work for a small, start-up medical device and we're just starting to generate promotional/advertising materials. I understand the basics of controlling these items, but am a bit lost on how to control our company website, landing pages, or other digital activities.

How are your digital promotional/advertising controlled? For videos, I think placement of a unique identifier with the boilerplate at the end of the video for a pre-determined amount of time would be sufficient (~3 seconds).

However, I'm stuck on determining identifiers and controls for the other items I've mentioned (company website, landing pages, etc.).

Any assistance would be greatly appreciated.

Tonia
 

yodon

Leader
Super Moderator
The way I've approached it is through segregation. You really only need to show control over information regarding claims. Keep those isolated and you can even include an identifier on the page with a version number. Those pages should be static and not change all that much (e.g., your IFU). I would avoid trying to control dynamic content (hence the segregation). If you have a blog site, avoid claims - only allow reviewed content to be posted. If you allow users to post, you need to monitor for off-label use, misuse, false claims, etc. I would avoid that. If you feel a need for allowing users to post blog entries, again, monitor and pull down posts that don't comply.

I do take a conservative approach; others may be not so anal. :)
 

mihzago

Trusted Information Resource
In my opinion, it depends on how conservative you are and how broad your definition of labeling accompanying your product.
As far as I know, but may be wrong, there is not a specific requirement for medical devices to place promotional and advertising information under document controls. I searched through the 21 CFR 800 and the Pre-Amble to QSR, and definitions in section 201(k) of the Federal Food, Drug, and Cosmetic Act, and did not find this requirement.
21CFR820.120 addressed labeling shipped with the product or accompanying the product, but it includes materials such as instructions for use.
I also searched Warning Letters, though not very extensively, but could not find any citations for lack of process for controlling advertising materials.


I think this requirement came from pharma, where specific requirements for promotional materials exist (e.g. balanced presentation), and from larger medical device companies with very formal quality systems that have written procedures to control every single activity.
It may also be that companies extend the requirement to control promo materials based on the definition of "Sec. 801.4 Meaning of intended uses" and misbranding in Sec. 801.6 Medical devices; misleading statements.

If your marketing or sales team tends to by slick and crafty, then placing your website and other promotional materials under strict control may make sense. Otherwise, again in my "less anal" than Yodon's opinion, controlling a website is an overkill for a start-up.
 

Mark Meer

Trusted Information Resource
...As far as I know, but may be wrong, there is not a specific requirement for medical devices to place promotional and advertising information under document controls...

I don't know...
According to this FDA page, Introduction to Medical Device Labeling:

The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. 'Accompanying' also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.
...
According to an appellate court decision: "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."

True, it doesn't speak of electronic/dynamic mediums specifically, but presumably these would fall under advertising, and hence labelling (and hence subject to controls).

To the OP's question though, a couple thoughts:
- Could you put an ID & revision in the page footer?
- Do you even need to have the ID & revision accessible to public? What's important is that you can identify and control, so perhaps putting the info into meta-data, or even something as simple as your file naming conventions might suffice?
 

mihzago

Trusted Information Resource
thanks for that info, Mark.
I thought I saw this before, but that it applies only to pharma.
 

mihzago

Trusted Information Resource
One thing i can add is a statement from the Guidance Document "Labeling - Regulatory Requirements for Medical Device"


"When reviewing or auditing labeling operations, it is wise to keep in mind that the GMP regulation contains flexigle requirements and thus allows flexibility in a quality assurance program. The degree of labeling control needed to satisfy the GMP regulation varies considerably for different devices and operations. In order to avoid wasting money and increasin the cost of health care, manufacturers need to give considerable and prudent thought to the appropriate level of control needed for their operations as allowed by 820.5. "
 
J

Jnks_Meddev

Can you please share their control of marketing/ promotional material procedure- especially for EU. We have one for US but I need to make sure that has the EU articles covered as well.
 

Mark Meer

Trusted Information Resource
Can you please share their control of marketing/ promotional material procedure- especially for EU. We have one for US but I need to make sure that has the EU articles covered as well.

If you have one for US it likely applies to EU as well - same principles.
Unless you have a good reason to have a specific procedure for control of US marketing materials, then I might suggest you are over-burdening yourself. Better approach is to have a generalized document control procedure that includes marketing material (irrespective of region) in the scope.
 
J

Jnks_Meddev

Apparently my manager likes the over burden. She wants me to create a procedure specific to EU.
Any help will be appreciated! Thanks.
 

sarushka

Registered
Hi ,
Has anybody here from Medical devices industry (not pharma) ever got cited by FDA ( on a 483 letter) for their misleading information on their marketing and promotional material? I want to know what level of RA/QA review and approval is required on these documents, some of our promotional and marketing material don't even have health-related claims on them , so I really don't think RA/QA review and approval is needed on such documents?
I appreciate your input. Thanks
 
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