How to control marketing documents in a medical device company

S

sardonyx

#1
How do you control marketing documents in a medical device company? Do you also issue part number with revision number? Do you require approval by responsible people involved in the marketing documents?:confused:
 
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S

sardonyx

#2
In addition to my questions, do we need to put the part number and revision number on the brochures if we need to control it? Since we are in medical device, this is more critical to just issue flyers or marketing brochures without any approval from the management or QA and RA (regulatory affairs). And I hope I would get answers with more knowldege in FDA compliance. Right now, we are controlling the marketing documents including brochures and flyers and we even put our internal part number on each pages so we can track them if those are the latest version. Are we doing the right things in FDA compliance? or are we so strict that we even put our part numbers on the brochures/flyers? Thanks in advance.:frust:
 
C

C Logan

#3
I am also in the same situation and could use some advice. Our Research deptarment is prodigious at creating new documents for a variety of diseases. I can not keep up!
 

amjadrana

Involved - Posts
#4
We are manufacturers of a medical device as well. We are keeping track of our brochures and flyers through document numbers and revision status. Appropriate persons from marketing, QA, and engineering have to approve these documents. All advertising material is part of labeling.

Even the website has to be controlled.

Amjad Rana
 

chris1price

Trusted Information Resource
#5
I would suggest that any document that falls under the category of labeling by the FDA requires formal change controls. FDA's definition of labeling is very broad and covers much of what Marketing may produce:

Section 201(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) accompanying 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.

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."
Taken from FDA web-site.


Whilst in theory it is possible to do this without a part number and revision level, it will quickly get very difficult.

Have a look at: http://www.fda.gov/cdrh/devadvice/33.html for further advise.
 
S

sardonyx

#6
Thank you all for your inputs! :thanx:
I think I'm on the right track then, controlling all marketing documents with revision number.
I will suggest the idea of controlling the website too.
 

chris1price

Trusted Information Resource
#7
You should certainly try to include web-sites, however this can be more difficult still as they are so easily changed. FDA do examine the claims made on web-sites and compare them to 510(k) claims. You need to be especially careful if your clains in USA are different from those in Europe or elsewhere!
 
S

sardonyx

#8
I initiated this post and my question was mentioned already above but wasn't received any clear response yet on whether is it possible to put the part number and revision number on the brochure or flyer itself. I know now that it's better to control the marketing documents but in what ways? Can I put part number and rev# on a flyer that has a dimension of 2"x2"? Like the flyer only says, The "medical device name" gives a peace of mind. What is the limitation and if this is not possible, how we will be able to control this flyer?
 
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