Is my product regulated by the FDA?
Under the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA regulates medical devices that are marketed and sold to consumers on the interstate market. Before diving into the regulations to determine the type of FDA requirements applicable to your product, you should consider a more preliminary question: Is my product a “device” regulated by the FDA?
For some products (like pacemakers, catheters, replacement heart valves, etc.), the answer is obvious: yes! But for other products, it is not as clear.
Section 201(h) of the FDCA (21 U.S.C. § 321(h) defines “device” as follows:
“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is-
(1) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
(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 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. The term ‘device’ does not include [certain software functions].”
When considering whether your product is a “device,” you should look to its intended use, which may be gleaned from labeling, advertising, oral or written statements, or other circumstances indicating that your product is offered or used for a certain purpose. Beware that devices cannot eschew FDA regulation simply by the avoidance of certain words or messages in its marketing.
You may also search the FDA database to see if similar products have been classified and regulated.
Originally published at https://www.lawbylevin.com on October 29, 2020.
