The FDA is proposing updates to its regulations in order to clarify the types of evidence that it considers when determining the "intended use" of a product. This proposal, if finalized, will amend the FDA's regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act (PHS Act), and the FDA's implementing regulations.
The FDA is proposing to amend its existing regulations (§§ 201.128 and 801.4 (21 CFR 201.128 and 801.4)) describing the types of evidence relevant to determining a product's intended uses, including whether a product meets the definition of a drug or device and whether an approved or cleared medical product is intended for a new use. Although the FDA issued a final rule in 2017 revising the language of the intended use amendments, on March 18, 2018, the FDA delayed the effective date of the intended use amendments. The FDA's amendments seek to clarify, for example, that a firm's knowledge that health care providers are prescribing or using its approved or cleared medical product for an unapproved use would not, by itself, automatically trigger obligations for the firm to provide labeling for that unapproved use. In addition, the FDA intends to clarify the types of evidence that are relevant to determining a product's intended uses.
The FDA's longstanding position is that, in evaluating a product's intended use, any relevant source of evidence may be considered. Evidence of intended use may include but is not limited to, the product's labeling, promotional claims, and advertising. For example, any claim or statement made by or on behalf of a firm that explicitly or implicitly promotes a product for a particular use may be taken into account. However, a firm's subjective claims of intent are not necessarily determinative of a product's intended use.
The FDA's proposed rule clarifies the types of evidence relevant to determining a product's intended uses, which includes the following:
- Express claims and representations: Any claim or statement made by or on behalf of a firm that explicitly represents a product for a particular use is relevant. This can include, but is not limited to, labeling claims and representations, advertising matter, and oral or written statements by persons responsible for the labeling, or their representatives.
- Implied claims: Any claim or statement made by or on behalf of a firm that implicitly represents a product for a particular use is also relevant to intended use. This can include, but is not limited to, suggestive product names, statements that imply an intended use, and representations that the product contains a particular ingredient to imply a physiological effect.
- Product characteristics and design: The characteristics of the product and its design are relevant to establishing intended use.
- Circumstances of the sale or distribution: The types of evidence relevant to establishing intended use also include circumstances surrounding the distribution of the product and the context in which it is sold.
The proposed rule clarifies the FDA's existing interpretation of the determination of the intended use of drugs and devices. Such clarity and consistency in the FDA's regulatory approach allows parties to understand their regulatory obligations and that the FDA can exercise effective oversight responsibility.
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