F
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
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