With devices, the premarket review process is generally more manageable: FDA classifies new devices according to the risks they pose.
The U.S. Food and Drug Administration is tasked by federal law with regulating a number of medical products including drugs, devices, biologics and dietary supplements. And FDA regulates each of these products—all of which are defined in the Federal Food, Drug and Cosmetics Act (FDCA)—differently. But what happens when a product fits the definition of more than one type of medical product?
As recently as April 2021, FDA has taken the position that where a product satisfies the statutory definition of both a drug and a device, the agency has the discretion to regulate the product as a drug. But in its recent opinion in Genus Medical Technologies LLC v. FDA—a decision with important consequences for medical device manufacturers—the District of Columbia Circuit Court of Appeals rejected FDA’s theory, finding that the agency lacks the authority to simply choose to regulate a product as a drug when it also satisfies the definition of a device.
Drug or Device—or Both?
The Genus Medical case concerned FDA’s regulation of Genus Medical’s Vanilla SilQ line of diagnostic contrast agents—specifically, whether the agency had the choice to regulate the contrast agents as drugs even though FDA acknowledged that the products seemed to meet the definition of devices. “Drugs” as defined in the FDCA include “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals,” 21 U.S.C. § 321(g)(1)(B) (emphasis added); “devices” include:
[A]n instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is… 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… 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.
Id. at § 321(h)(1) (Emphasis added.)
The D.C. Circuit Court of Appeals recognized that, as a result of the overlap in the definitions, a product that satisfies the “device” definition also necessarily satisfies the “drug” definition because both share the “intended for use” provision and the “drug” definition contains no further limitations. (The opposite is not true; something that satisfies the definition of a drug does not necessarily fall within the definition of a device where, for instance, it is not an instrument, apparatus, implement, machine, etc., or where it achieves its primary intended purpose through chemical action within or on the body and which is not dependent upon being metabolized for achievement of its primary intended purpose.)
A Distinction with a (Potentially Significant) Difference
The fact that a single medical product such as Genus Medical’s Vanilla SilQ contrast agent may be both a drug and a device according to the definitions in the FDCA is more than a distinction without a difference; as the Genus Medical litigation made clear, the distinction is sometimes worth filing a federal lawsuit over. As noted above, drugs and devices are subject to different regulatory requirements. For instance, before a new drug (i.e., one that is not sufficiently similar to one that FDA has already approved) may be brought to market, it must go through a rigorous, lengthy and expensive premarket approval process. With devices, the premarket review process is generally more manageable: FDA classifies new devices according to the risks they pose. To market products deemed to pose the (relative) highest risk of illness or injury (Class III products), FDA must be given detailed information on the safety and efficacy of the product and have “reasonable assurance” that the device is safe and effective. As a result, it is typically more expensive to develop and market a new drug than it is to do the same for a device. In Genus Medical, the manufacturer quantified the problem, estimating that while it would cost approximately $60,000 to seek device clearance for Vanilla SilQ, it would cost more than $500,000 to obtain premarket approval for the product as a drug—in addition to an annual recurring cost of more than $186,000 to continue marketing the product as a drug.
Products Satisfying the Definition of Devices Must Be Regulated As Such
Genus Medical argued that Vanilla SilQ—an oral contrast solution used in combination with X-ray exams or other radiology procedures in order to enhance the view of the gastrointestinal tract for diagnostic purposes—should have been classified as a device because it satisfied the definition of a device described above. FDA disagreed, stating that, although the product “appear[ed]” to satisfy the “device” definition, it also satisfied the “drug” definition. Moreover, FDA reasoned that because not all contrast agents meet the definition of a device, its practice has been to regulate all contrast agents as drugs for purposes of consistency.
Applying the interpretive principle that “the specific must govern the general,” the D.C. Circuit sided with Genus Medical, finding that because the definition of a device in the FDCA is drawn more narrowly than the definition of a drug, to the extent that Vanilla SilQ satisfied the definition of a device (something FDA appeared to acknowledge), it should be regulated as a device rather than a drug given the differences in regulatory regimes. In other words, FDA had no basis under the FDCA or any other statute to simply decide to regulate the product as a drug even though it satisfied the definition of a device.
For More Information
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