Warnings and Cautions

Subject: Warnings and Cautions
From: Lynda Shindley <LShindley -at- ANGEION -dot- COM>
Date: Fri, 1 Aug 1997 13:13:34 -0500

This is an interesting thread. The FDA defines Cautions and Warnings in a booklet called Write it Right, and other regulatory documentation, as follows:

"Warning" is used . . .to alert the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the product.

"Caution" is used . . . to alert the user to the possibility of a problem with the product associated with its use or misuse. Problems can include product malfunctions, product failure, and/or damage to the product or damage to other property.

When using one of the above, we have to state the situation followed by a consequence if the user does not follow the instructions. Warnings and cautions must accompany the instructions, generally listed just before the instruction where the warning or caution applies.

Our company has gone to great lengths to present Warnings and Cautions correctly. If you need more info, contact me off the list.

Lynda Shindley
lshindley -at- angeion -dot- com
Minneapolis, MN

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