|Footnotes for this article are available at the end of this page.
In 1970, Gordon Lightfoot released the classic song “If You Could Read My Mind,” where he sings, “If you could read my mind, love, what a tale your thoughts could tell.” Fifty-one years later, the Food and Drug Administration issued a Final Rule to amend its regulations that define “intended use.”1 The Rule is effective September 1, 2021.
This Bulletin summarizes many of the key provisions of the Final Rule and some of the FDA’s responses to comments from the industry.
Some Industry Comments and FDA Responses
- FDA stated several times in the Federal Register that its policies were not new.
- The agency rejected a comment that evidence of intended use is limited to promotional claims. FDA responded: “Nothing in the statute requires the narrow scope that the comment suggested… The fact that intended use can be established through promotional claims does not preclude the possibility that other evidence may be relevant as well.”
- FDA said that it “may look to any relevant source of evidence,” “including a variety of direct and circumstantial evidence” (e.g., product formulation, method of intake, actual use of product).
- The agency noted that it might consider a product’s design and composition when evaluating “intended use.” “For example, FDA may consider the design or composition of a product, which includes product characteristics, when determining whether the product is intended to affect the structure or any function of the body,” which could make the product a “device” under the Federal Food, Drug, and Cosmetic Act.
- FDA stated that it did not believe its Final Rule raised First Amendment concerns because the “intended use regulations describe evidence that may be relevant to establishing intended use; they do not in themselves directly regulate speech.” The agency also concluded that the intended use regulations are not unconstitutionally vague in violation of the Fifth Amendment.
- The agency clarified that the intended use regulation for medical devices (21 C.F.R. 801.4) applies to devices that are exempt from pre-market notification (i.e., 510(k)-exempt) and devices that are granted marketing authorization through De Novo classification.
- FDA decided not to establish a “safe harbor” for scientific exchange of information, where such exchange would be excluded from determinations of intended use. The agency recognized the value of sharing certain types of off-label information with doctors, but also had concerns about the promotion of new intended uses “based on incomplete or otherwise flawed data.” FDA ultimately decided that the Final Rule was not the appropriate forum to resolve the “scientific exchange” issue.
- FDA made clear throughout the Final Rule that it did not think its revisions to the intended use regulations were significant, and there was no change in its policies and practices. Perhaps, any change was the finality and clarity of the message. The agency is making clear that it will evaluate a number of factors, not merely promotional claims, when determining intended use. FDA is reminding the industry that it is the sole arbiter of “intended use,” but to some extent, that has always been FDA’s position.
- FDA acknowledged the benefits of certain types of scientific exchange but, then again, does not want to wade into the potential constitutional quagmire where it has often sunk (although it doesn’t think this Final Rule raises First Amendment issues). In addition, companies should keep in mind that the agency might look to scientific exchange as evidence of intended use.
- FDA reminded us that the agency does not intend to consider a firm’s knowledge that a healthcare provider has used or prescribed the firm’s product for an unapproved use, by itself, as sufficient to establish intended use (i.e., FDA may consider such knowledge, in addition to other relevant evidence).
- As companies continue to develop promotional and marketing materials, as well as design and composition development, among other things, they must recognize that FDA will evaluate all of these factors, but not only these factors. When the FDA tries to read your company’s mind, what type of tale does the agency think it will tell?
 See 86 Fed. Reg. 41383 (August 2, 2021), amending 21 C.F.R. §§ 201.128 and 801.4.