Hello <g class="gr_ gr_5 gr-alert gr_spell gr_disable_anim_appear ContextualSpelling ins-del multiReplace" id="5" data-gr-id="5">Shiven</g>,
Take a look at FDA's
2001 Guidance on Medical Device Patient Labeling. Here are some excerpts:
Contraindications are conditions under which the device should not be used because the risk of use clearly outweighs any possible benefit.
Warnings and precautions tell the reader about hazards, other than those that are contraindications to <g class="gr_ gr_860 gr-alert gr_spell gr_run_anim ContextualSpelling" id="860" data-gr-id="860">device</g> use. Warnings and precautions provide information on how to avoid these hazards, i.e., sources of harm in the use of the device.
A warning alerts the reader about a situation which, if not avoided, could result in death or serious injury. It may also describe potential serious adverse reactions and safety hazards. The designation of a hazard alert as a “warning” is reserved for the most significant problems. The term WARNING is generally used as the signal word for this type of hazard alert. If a problem may lead to death or serious injury, FDA may expect you to highlight the warning by placing it in a box.
The term precaution is used for the statement of a hazard alert that warns the reader of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property. It may also be used to alert against unsafe practices. This includes the special care necessary for the safe and effective use of the device and the care necessary to avoid damage to a device that may occur as a result of use or misuse. The word CAUTION is generally used as the signal word for a precaution statement.
The distinction between warnings and precautions is a matter of degree of likelihood and seriousness of the hazard. The target audience for medical device labeling (health care practitioners and lay users of home use devices) generally recognize a hierarchy of hazard alerts, with warnings being those of a more serious nature and precautions being of a less serious, but important, nature.
What is appropriate content of an effective warning or precaution?
There are four elements generally recognized by the courts and research as necessary for an effective warning or precaution:
• a signal word (WARNING, CAUTION) to alert the reader that what follows is important hazard information. A symbol or icon may emphasize the effect of the signal word. Additional enhancement, such as bolding, larger type, underlining, italics, or color may help the information stand out from the rest of the text. However, studies have demonstrated that a large difference in font size between the signal word and the text may de-emphasize the importance of the text and therefore reduce the likelihood that the text will be read.
• a hazard avoidance directive in the form: Do Not, Never, Avoid...” (or Do, if more appropriate) followed by the action to avoid (or perform). The objective of this directive is to give clear instructions to the user on how to avoid the hazard.
• a clear statement of the nature of the hazard associated with the warning (e.g., allergic reaction to <g data-gr-id="512" id="512" class="gr_ gr_512 gr-alert gr_gramm gr_disable_anim_appear Grammar only-ins replaceWithoutSep">material</g>, strong magnetic field) or precaution (e.g., environmental effect, damage from resterilization) that characterizes the severity and the likelihood.
• the consequences, specifying the serious adverse events, potential safety hazards and limitations in device use that result if users do not follow instructions.
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Sam Lazzara
http://www.lazzara.netsam@lazzara.net------------------------------
Original Message:
Sent: 26-Jan-2017 18:30
From: Shiven Gandhi
Subject: Warnings vs. Precaution vs. Contraindications
Hello,
My understanding of the terms 'Contraindication' is that it is known situation under which a device should not be used because the risk of use clearly outweighs any possible benefits while 'Warnings' are potential safety hazards when there is a lack of valid scientific evidence.
I would like to understand the difference between Warnings and Precaution. It will be helpful if you share examples of each of them.
Thank you
Shiven
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[Shiven]
[Regulatory Affairs]
[San Francisco] [CA]
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