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FDA’s “Intended Use” and “Indications for Use”
....cont'd
“Intended Use” is therefore the “Objective Intent” for the device of the persons legally responsible for labeling the device. It is in fact a regulatory term that paints a distinctive and overall picture to define what the product is intended for. Unlike “Indications for Use” (which we’ll get to in a minute), the Intended Use does not necessarily come in a written paragraph form. It is constructed by several media including: labeling, word of mouth, and advertising.
A change to Intended Use is usually considered for a new submission when it could significantly affect the safety or effectiveness of the device. Such things as the change from prescription to over the counter use is one example when a device would require a new 510(k). Another example when a change is considered significant is when a device goes from single use to multi-use.
INDICATIONS FOR USE
Unlike Intended Use where the term is used in a very regulatory fashion and can be derived by several input avenues and is amorphous in nature, Indications for Use has a very definite structure.
Indications for Use is defined by the FDA as:
The general statement of the "Indications for Use" identifies the target population in a significant portion of which sufficient valid scientific evidence has demonstrated that the device as labeled will provide clinically significant results and at the same time does not present an unreasonable risk of illness or injury associated with the use of the device. As appropriate, the labeling should state that the device (trade name) is "indicated" or "intended for use"
(1) in the treatment, mitigation, prevention or diagnosis of a recognized disease or condition or an important manifestation of a disease or condition; and/or,
(2) in the relief or mitigation of symptoms associated with a disease or condition; and/or,
(3) as an aid or adjunct to a mode of therapy or diagnosis..