Indications for Use
General Statement of Indications for Use
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"
http://www.fda.gov/RegulatoryInformation/Guidances/ucm081368...