By FDA regulation, 21 C.F.R. § 801.4, the intended use of a device refers “to the objective intent of the persons legally responsible for the labeling of device.” Thus, the intended use is controlled by the company’s own words.
The definition does go on to say that the intended use can be established by known off-label use of the device. That portion of the regulation, which has created considerable confusion, can essentially be ignored.
The intended use is determined by the applicant, not by subsequent third party use. If FDA believes that a device that is the subject of a 510(k) premarket notification is likely to be used off-label and that a particular use may present health risks, FDA can mandate a warning against that use. FDA cannot, however, reject a 510(k) because of anticipated off-label use.
The intended use will delineate and circumscribe the company’s ability to promote its IVD. All “labeling” must be consistent with the intended use.
Labeling is broadly defined by law, and covers virtually all promotional materials created or distributed by the company or its agents. Oral communications, such as statements by sales representatives, must also be consistent with the intended use statement. Claims that go beyond the labeled intended use are deemed off-label and can result in FDA enforcement action.
Thus, submitting an application for a narrow, unmarketable intended use simply to obtain FDA clearance can result in a commercial dead end. The product may lawfully be sold, but the ability to promote it would be fatally constrained.
Intended use should not be drafted solely with the input of regulatory personnel. Sales and marketing personnel should provide guidance, as well. Companies must consider the potential impact of the intended use on the commercial success of the product.
The FDA regulatory process will culminate in an approval or clearance for a clearly defined intended use. The final labeling will explicitly state the product’s intended use.
For 510(k) notices, the intended use (or, more precisely, “Statement of Indications for Use”) is actually recited in a special, publicly available form submitted by the company to the FDA. While the meaning of the intended-use statement can be ambiguous, there is no uncertainty as to the words themselves. These words constrain product promotion. As an FDA guideline says, the intended use “must be consistent with your labeling, advertising, and instructions for use.”
They also play a pivotal role in the ability to secure adequate insurance coverage. Therefore, they need to be consistent with the company’s long-term commercial objectives.