August 5, 2021
Intended Use vs. Indications For Use: What’s the Difference?
Successful premarket regulatory strategy and authorizations weigh heavily on proper understanding between the term “Intended Use” as distinguished from “Indications for Use”. That said, it can be difficult to find clearly defined explanations of these terms. For the U.S. FDA jurisdiction, I have given FDA’s approach hereinafter.
In guidance and in 21 CFR §801.4, the FDA has defined the term “Intended Use” as the objective intent of the persons legally responsible for the labeling of the device. The intent is determined by their expressions or may be shown by the circumstances surrounding the distribution of the device. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such representatives. Moreover, it may be shown by the offering or the using of the device, with the knowledge of such persons or their representatives, for a purpose for which it is neither labeled nor advertised. These provisions are driven by the definition in U.S. medical device law at Section 513(i)(1)(E)(i) of the FD&C Act. Accordingly, the device labeling as well as known uses are primary focal points when determining a device’s Intended Use.
In contrast, the term ‘Indications for Use’ describes the disease or condition the device will diagnose, treat, prevent, cure or mitigate, including a description of the patient population for which the device is intended. For example, see FDA’s 21 CFR §814.20(b)(3)(i).
But distinguishing these terms can get a bit tricky sometimes. A device’s Intended Use isn’t necessarily the same as its Indications for Use, yet not necessarily different. But they will always be intrinsically related. In practice, the Intended Use of a subject device may either be inherently general, or more specific. Yet a very specific Indication for Use could be one and the same with the Intended Use. Indeed, FDA says that for devices with general indications for use that do not specify a disease, condition, or population (or an anatomical site from which a disease state or population may be inferred), the indications for use and intended use are the same. Such indications for use are referred to as “tool type” indications for use. And there can also of course be a general Intended Use plus a specific Indication(s) for Use under the general Intended Use.
Ultimately, FDA reminds us that consistency between the Indications for Use statement and the proposed labeling (which, remember, is used to determine the Intended Use) will facilitate the review of premarket submissions.