Does the change affect the indications for use?
The general statement of the “Indications for Use” identifies the target population in a significant portion of which sufficient 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.12 Changes in the indications for use section of labeling raise more agency concern than any other aspect of labeling. In fact, most changes in this part of the labeling will require the submission of a 510(k). Any change in the indications for use that limits use to within the currently cleared indication may occur without the submission of a 510(k). For example, the device was cleared for use with three specific indications and the firm decides to market the device for only two of those indications, would not require submission of a new 510(k). Another example would be further limiting the patient population by age or weight e.g., if y
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- Does the change affect the indications for use?
