Should Product Website Content be treated as Labeling?

E

esalsan

#1
Dear covers,

I have a dilema regarding the applicable controls over the content of a product website.

Reading the FDA Guidance on "Labeling", published in August 1989 (text quoted below in italics), and the "Device Labeling" website from the FDA "Device Advice" site, I understand that the website content related to a product falls under the definition of labeling, in the same way that their paper equivalents (brochures, posters, etc.) do.

If the assumption is correct, 21 CFR 801 and 820 are applicable to them and the content needs to be reviewed and therefore the Device History Record (DHR) updated with the reviewer and the date of the review. It seems to me a little unpractical to update the DHR when the product website is updated (although I understand the reasons for it). How do other people deal with this issue?

As an additional note, probably irrelevant to this post, We "manufacture" standalone software that is classified as a class II medical device.

Thank you in advance for your response,

esalsan

-------------------
Section 201 of the FD&C Act distinguishes between label and labeling. Certain provisions in Chapter V of the FD&C Act apply specifically to the "label" of the device, others are related to its "labeling." These terms are related, but not interchangeable. Of the two, the term "label" is more restricted. Generally, it consists of that art of the display confined to the device itself. On the other hand, "labeling" deals wit the label on the device, and descriptive and informational literature that accompanies the device.
Section 201 (k) defines "label" as a:
* "display of written, printed, or graphic matter upon the immediate container of any article.. . "
The term "immediate container" does not include package liners. Any word, statement, or other information appearing on the immediate contamer must also appear "on the outside container or wrapper, lf any there be, of the retail package of such article, or is easily legible through the outside container or wrapper."
Section 20 1 (m) defines "labeling" as:
* "all labels and other written, printed, or graphic matter
(1) upon any article or any of its containers or wrappers, or
(2) accompanyin such article" at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.
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.
 
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2

20130523

#2
Without getting into the technical pieces of what is included in the CFR (I'll let someone else lead you there, I would hate to stray you incorrectly), I would ask why information would be different on the product website?

I am not Class II, I am in Class I, so certainly I have less FDA intervention, however, with that being said, I do host product information on my website and it is considered Marketing Collateral, which falls under labeling. Labeling is primarily concerned with packaging, but I have had to review spec sheets and hand outs before to make sure we have proper use of the labeling requirements.

I do not have to update the DHR or technical file, because it is just a revision of information published, not a change to the product. In the event the product is changed, then my Technical file is updated, and that triggers the review of collateral and media for the product on a companywide level.

Hope that helped.
 
L

lynchoid - 2012

#3
The FDA definitely considers website product content to be labeling. However, the DHR does not need to be changed, nor the DHF unless the product itself changes. You may want to consider printing out pages from the website (or PDFing them) and saving them with an approval signature to document that the labeling has been reviewed for appropriateness.
 
G

George Weiss

#4
There is a good question in this website comment.
I am betting there are wiggle methods to solve everything when viewed from the right angle.
I read this earlier, and was also saying to my self now what would I do?
I am guessing that a website does not have to be controlled as your question, questioned.
It is the product information, which is looking for control of revision.
SO: As is done a great deal, be sure your website information is contained in a PDF secured document.
I am sure you can reasonably control the PDF posted revision and let the website operate.
I am sure to be missing something.
PLEASE someone correct me ! ! ! !
 
E

esalsan

#5
Thank you all for your valuable input.

My major concern was about the DHR, as it should contain (or reference to) "[FONT=&quot]The primary identification label and labeling used for each production unit".[/FONT]
Ambir775, your question is a valid one as well: most of the product information in the website is already in the brochure, but marketing always want to add some more (which requires me to check it).

Thanks again!
 

yodon

Staff member
Super Moderator
#6
This is, indeed, an interesting question... and one I'm trying to deal with as well.

In theory, a web page could be dynamically constructed and specific information presented. That would be a more customer-centric approach than offering up entire PDF images and telling the user to go find it in there somewhere. Yet another concern is blogs. I believe I've already heard of cases where FDA cited claims made in blogs that weren't substantiated. So the static model of document approval really falls short with this (and other so-called social media; e.g., Facebook, Twitter, etc.).

We're trying the print-a-shapshot-and-approve approach as we don't currently have much in the way of dynamic content. We do have a blog and I'm going to get it set up as an RSS feed so I can be notified when an update is made and be able to take appropriate actions if something inappropriate is posted. I'm going ostrich mode (burying my head in the sand) on other social media for now. I'll probably try to push a policy of "just don't" for these.

If someone has thoughts on managing dynamic content, I would really appreciate some feedback.
 
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