Originally published in Healthcare Michigan, Volume 41,  No. 4

The Food and Drug Administration (FDA) regulates foods and beverages, drugs and medical devices, biologics, dietary supplements, tobacco products, veterinary products, and cosmetics. Although these various product categories may appear to be clearly cut, the fact of the matter is that a product can very easily cross over from one product category to a different one as a result of issues such as in intended use, composition, labeling content or other claims, or other such issues that may seem to be inconsequential. At the earliest possible stage of product development, it is important to evaluate the identity of the product based on these and other factors, and to anticipate the manner in which the product will be marketed and advertised including, most significantly, the claims that will be made in relation to the product and its capabilities.

Product Classification. There are specific statutory definitions that ultimately dictate the categorization of a given FDA-regulated product. Consulting the applicable definitions and evaluating the specifics of a given product under applicable laws and FDA guidance documents is a technical and fact-specific exercise. Portions of the “drug” and “medical device” definitions help to illustrate how easily the lines can be crossed and result in unanticipated product cross-over into a new and potentially more rigorously regulated product category. Section 201(g) of the Food Drug & Cosmetics Act (the “Act”) defines the term “drug” in relevant part for illustration purposes to mean:

… (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; …[.]

Similarly, Section 201(h) of the Act defines the term “device” in relevant part for illustration purposes to mean:

… an instrument … or other similar or related article, including any component, part, or accessory, which is … (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Application of just these excerpted definitions to everyday consumer products demonstrates how 1. a household cleansing wipe that is marketed as having the ability to kill flu or other viruses for the prevention of disease becomes a regulated medical device; 2. a mobile application that claims to diagnose the symptoms of a heart attack or other cardiac event becomes a medical device; and 3. a cosmetic advertised as an acne or wrinkle treatment becomes a drug product.

It is important to note that, although often one of the last items in production, product labeling is a critical element of the regulatory analysis and should be contemplated and assessed as early as possible. The product labeling requirements are specific to the product category and, in addition, can contain claims and other information that may impact the regulatory analysis. The content of product labeling should not be an after-thought, but should be planned and reviewed for compliance in advance.

Regulatory Pathway. The regulatory pathway required for a given product is determined by the categorization and classification of the product. For some categories, categorization is not the end of the analysis, and there are additional analyses to be undertaken. Within the medical device category, for example, there are three separate classifications based upon the product’s risk profile. As such, a product in the medical device category must be further analyzed to determine the classification into which it fits and, therefore, the applicable requirements for registration and listing, clearance, approval, or other steps that must be taken before the product can be commercialized in the marketplace. Specific additional requirements applicable to drugs and other products may, similarly, apply. Because the various regulatory pathways can require vastly different spans of time (up to many years in some instances) and other requirements (including completion of product testing and clinical research in some cases) for completion, and like the product classification analysis, consideration must be given to this analysis at the earliest stage possible. As such, product developers and others engaged in the product lifecycle are well-advised to engage with qualified FDA regulatory counsel as an early-stage step to ensure appropriate for research, consultation and analysis can be undertaken and completed on each of these issues.

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