The FDA published on Monday, June 27, 2011 two guidance documents concerning the regulation of medical devices. See Classification of Products as Drugs and Devices and Additional Product Classification Issues; Interpretation of the Term “Chemical Action” in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act.
Section 201(h) of the Federal Food Drug and Cosmetic Act defines the term “device” to include a product that is, inter alia, “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.” (emphasis added).
If a product is intended to affect the structure or any function of the body through chemical action, the product is generally a drug. In its latest guidance on medical devices, the FDA explains that “chemical action” includes a product that “through either chemical reaction or intermolecular forces or both, the product: mediates a bodily response at the cellular or molecular level, or combines with or modifies and entity so as to alter that entity’s interaction with the body of man or other animals.”
In most cases, the product’s intended effect is readily apparent. The FDA’s recent guidance documents, however, underscore the need to classify properly a product that may be subject to drug regulations. Products may satisfy both the device and (more expansive) drug definitions. To complicate matters further, some products may overlap the definition of biologic in 42 U.S.C. § 262(i). Manufacturers or practitioners with products used in blood therapies, chelation, or transfusions should determine whether the devices used are primarily intended to perform physical or chemical alterations.
Do not hesitate to contact us with any questions concerning device regulation.