Intended Use Based on Actual Use
One of the most important regulatory concepts in the FDCA is that of “intended use.” That term plays a pivotal role in establishing the applicable regulatory requirements. Historically, intended use has been determined by the conduct of the manufacturer.
The intended use of a product is not based only on what words appear on the label, but what the manufacturer says about its product. A product would be regulated as a device if the manufacturer made diagnostic claims about it, even if the product itself was labeled RUO. The intended use of a product, though, has not been altered by the conduct of the purchaser. A manufacturer whose drug or device was approved for treating X does not face charges of off-label promotion because physicians use it to treat condition Y.
The draft document, however, states that the intended use of a product is altered by the conduct of its purchasers. According to FDA, “intended use may be shown by the circumstances surrounding the distribution of the product and the manufacturer's knowledge that its product is offered and used for a purpose for which it is neither labeled nor advertised.”
Under the draft guidance, a company selling an RUO or IUO product that learns a customer is using a product for diagnostic purposes should “halt” sales of that product. This termination of sales to customers should take place even in the absence of actual knowledge, i.e., if the manufacturer has reason to know of the diagnostic usage.
This element of the draft guidance, if adopted, would have major repercussions for companies selling RUO or IUO products. Read literally, the policy would require the immediate cessation of sales to an RUO or IUO laboratory customer based on any diagnostic usage. No transition period is currently permitted under the draft guidance. This could be very disruptive to the manufacturer, the laboratory, and patients.
More broadly, this approach potentially represents a shift in FDA's approach to offlabel use for FDA-regulated products. Drugs and devices are routinely used off-label. It is unclear what impact, if any, the approach adopted here toward RUOs and IUOs would have if applied to other FDA-regulated products in which off-label use occurs.