"Labeling" vs "Accompanying Documentation" - FDA Definitions

[frivolas]

Hi all!

This morning I got in a philosophical discussion with one of my colleagues about the meanings of and differences between the terms "Labeling" and "Accompanying Documentation".

We've been indiscriminately using Labeling and Accompanying Documentation when we refer to the instructions for use, user manuals, quick guides, troubleshooting guides and labels. And we'd like to get to an agreement of what is the right term.

The 62366 makes a somewhat good job in defining what "Accompanying Documentation" is. It only mentions the term "labeling" in a couple of examples, and those times it can be interpreted (from the context) that they are talking about the labels only.

Then the FDA has a definition for both Label and Labeling, and the one for Labeling may also be used to include any other document provided with the product.

So, looking forward to keep this conversation going, or eventually end it, what term do you use? Does the FDA prefers one over the other? Would we be in troubles if we use one or the other in our design control documents? Or does it matter at all how we call it?

Thanks!
Oscar

 

[frivolas]

Re: "Labeling" vs "Accompanying Documentation"

These are the FDA definitions I'm talking about (as I can't post links yet):

The Federal Food, Drug and Cosmetic Act (FFDCA) is the law under which the FDA takes action against regulated products. Specifically:

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 container must also appear 'on the outside container or wrapper, if any there be, of the retain package of such article, or is easily legible through the outside container of wrapper.'

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.

Thanks!

 

[yodon]

Re: "Labeling" vs "Accompanying Documentation"

I don't guess it matters too much what you call it as long as you meet the regulations in terms of content and control. Straying from the definitions may lead you into trouble (e.g., "we don't consider the website as labeling even though the claims are stated" would be incorrect).