## Facts

- Genus Medical Technologies LLC manufactured “Vanilla SilQ,” a barium sulfate oral contrast agent used in radiological imaging to improve visualization of the gastrointestinal tract.
- Under the Federal Food, Drug, and Cosmetic Act (FDCA), “drugs” and “devices” are subject to distinct regulatory regimes; compliance with the drug regime is generally more burdensome.
- Genus sought to have Vanilla SilQ regulated as a “device,” asserting it met the statutory device definition because it achieves its intended purpose without chemical action and without being metabolized.
- FDA acknowledged Vanilla SilQ “appears” to satisfy the device definition but classified it as a “drug,” citing an agency policy of regulating all contrast agents as drugs to maintain uniformity.
- Genus pursued administrative reconsideration; FDA denied relief.
- Genus sued under the FDCA and the Administrative Procedure Act (APA). The district court granted summary judgment for Genus and vacated FDA’s classification decision.
- FDA appealed to the D.C. Circuit.

## Issues

1. Whether the FDCA permits FDA to classify a product that meets the statutory definition of a “device” as a “drug” based on definitional overlap and policy considerations.
2. Whether FDA’s classification decision was unlawful under the APA because it conflicted with unambiguous statutory text and structure.

## Decision

- The D.C. Circuit affirmed the district court’s summary judgment for Genus.
- The court held the FDCA unambiguously requires FDA to regulate products meeting the device definition as devices.
- Because the statute was unambiguous, FDA’s contrary interpretation received no deference.
- The court agreed that FDA’s drug classification was not in accordance with law under the APA and upheld vacatur of the classification decision with remand for further proceedings consistent with the opinion.

## Legal Principles

- When a statute creates distinct regulatory categories and a product satisfies the more specific statutory definition, the agency must apply that category and may not select a different regime based on policy preferences.
- Overlap between broad and specific definitional language does not, without clear statutory authorization, confer agency discretion to choose between mutually exclusive regulatory frameworks.
- Chevron step one applies where statutory text, structure, and context resolve the classification question; agency views cannot override unambiguous congressional choices.
- Agency consistency or uniformity rationales cannot justify action that conflicts with statutory limits; such action is unlawful under the APA as “not in accordance with law.”

## Conclusion

The court held that FDA lacked discretion to regulate Vanilla SilQ as a drug after concluding it met the FDCA’s definition of a device, and it affirmed vacatur of FDA’s classification decision because the FDCA’s text and structure foreclosed the agency’s policy-based approach.


Genus Medical Technologies LLC v. Food & Drug Administration, 994 F.3d 631 (D.C. Cir. 2021)