In a notice published in the Federal Register on August 9, 2021, the U.S. Food and Drug Administration (FDA) announced it will implement a recent court decision and will begin to reclassify as devices certain diagnostic imaging agents that had been approved as drugs.
In April, the U.S. Court of Appeals for the District of Columbia Circuit ruled in Genus Med. Techs., LLC v. FDA, 2021 U.S. App. Lexis 10928 that the FDA did not have regulatory authority to classify some diagnostic imaging contrast agents as drugs when they also met the definition of a device under the Federal Food, Drug, and Cosmetic Act. In the Genus litigation, both the District Court and the Court of Appeals disagreed with FDA’s view that the agency had the discretion to regulate products meeting the device definition as drugs. My Reed Smith partner, Eric Alexander, provided an excellent summary and analysis of the Genus decision in this blog post.
In the Federal Register notice, FDA said it will not appeal the ruling and will align "borderline" products with the court decision. “FDA intends to regulate products that meet both the device and drug definition as devices, except where the statute indicates that Congress intended a different classification, and we further intend to bring previously classified products into line with the Genus decision."
The notice marks a significant change by FDA, which had consistently regulated diagnostic imaging agents as drugs, rather than devices, even though some imaging agents meet the definition of both a drug and a device. Historically, FDA had regulated imaging agents as drugs regardless of whether they served as an enhancement for images produced by devices (like ultrasound, CT, and MRI scanners) or whether they were necessary to produce the image itself (like radiopharmaceuticals). The agency stated that, “Following the Genus decision, we intend to reexamine whether individual imaging agents meet the device definition, including whether they achieve their primary intended purposes through chemical action within or on the body or are dependent upon being metabolized for the achievement of their primary intended purposes.”
In its notice, FDA invited stakeholders to submit comments regarding categories of products currently regulated as drugs that may be required to transition to device status under Genus. FDA said comments are also welcome regarding statutory provisions other than the drug and device definitions that may indicate Congressional intention regarding the appropriate regulatory pathway (i.e., drug or device) for certain types of products.
FDA plans to publish in a future Federal Register notice a list of approved drug products that the agency has tentatively determined should transition to device status pursuant to the Genus decision. Stakeholders, the agency said, would then have an opportunity to comment on those tentative determinations before final classification determinations are announced.