Genus Medical Technologies LLC v. FDA, 994 F.3d 631

The FDCA defines "drug" broadly (articles intended for diagnosis/treatment) and "device" more narrowly (instrument/apparatus/etc. that does not achieve its primary purpose through chemical action or metabolization).
Genus manufactured "Vanilla SilQ," an oral barium-sulfate contrast agent used to enhance gastrointestinal X-rays; FDA acknowledged Vanilla SilQ "appears" to meet the device definition.
In 2017 the FDA issued a warning letter and, via the Office of Combination Products (OCP), formally designated Vanilla SilQ as a drug, explaining it regulates contrast agents uniformly as drugs.
Genus filed an RFD and then sued, arguing the FDA lacked statutory authority to treat a product that meets the device definition as a drug; the district court granted summary judgment for Genus and vacated the FDA’s decision.
The D.C. Circuit reviewed de novo and held the FDCA’s text, structure, and legislative history unambiguously foreclose the FDA’s claimed discretion to classify as a drug any product that satisfies the device definition (except for combination products governed by 21 U.S.C. § 353(g)).
The court affirmed the district court, set aside the FDA’s device-as-drug classification, and reserved the separate factual question whether Vanilla SilQ actually satisfies the device definition’s instrument and mode-of-action clauses.

Issue	Plaintiff's Argument (Genus)	Defendant's Argument (FDA)	Held
Whether FDA has discretion to classify as a "drug" a product that also meets the device definition	No — if a product meets device definition it must be regulated as a device; specific device provisions control the general drug definition	Yes — overlapping definitions create ambiguity; Congress removed an exclusion in 1990, so FDA may choose either pathway	Held: No broad discretion; the FDCA requires devices (except combination products) be regulated as devices; FDA’s contrary interpretation unlawful
Effect of the 1990 SMDA amendment that removed an explicit device exclusion from the drug definition	The deletion did not give FDA sweeping reclassification power; it was aimed at enabling regulation of combination products	The deletion shows Congress intended to permit FDA to regulate overlapping products as either drugs or devices	Held: Deletion addressed combination products and did not grant near‑limitless agency authority to treat all devices as drugs
Whether FDARA provisions concerning contrast agents ratify FDA practice of treating contrast agents as drugs	Genus: FDARA does not broadly require or ratify treating all contrast agents as drugs	FDA: FDARA language (and practical considerations) indicates congressional approval of treating contrast agents as drugs	Held: FDARA’s narrow, subsection‑specific language does not evidence an intent to endorse a general rule classifying all contrast agents as drugs

Chevron U.S.A., Inc. v. Natural Resources Defense Council, 467 U.S. 837 (agency deference framework)
Medtronic, Inc. v. Lohr, 518 U.S. 470 (device classification and device classes)
Fourco Glass Co. v. Transmirra Prods. Corp., 353 U.S. 222 (specific governs the general within same statute)
United States v. Article of Drug, Bacto-Unidisk, 394 U.S. 784 (recognizing definitional overlap of drugs and devices)
Whitman v. American Trucking Ass'ns, 531 U.S. 457 (clear‑statement concerns; agencies do not get large grants via vague text)
Motor Vehicle Mfrs. Ass'n v. State Farm, 463 U.S. 29 (arbitrary and capricious review)
SEC v. Chenery Corp., 318 U.S. 80 (court may not uphold agency on new grounds not relied on by agency)
Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399 (start statutory interpretation with text)
RadLAX Gateway Hotel, LLC v. Amalgamated Bank, 566 U.S. 639 (application of general‑vs‑specific canon)