## Facts

- Inventive Products, Inc. manufactured and distributed the “Sensor Pad,” a flat circular latex bag filled with silicone lubricant intended to be placed over the breast during self-examination to improve detection of abnormalities.
- The product was marketed as aiding early detection of breast cancer by enhancing breast self-examination.
- Seeking confirmation that the product was not regulated, the company submitted a premarket notification (510(k)) to the FDA in 1985.
- In 1986, the FDA informed the company it viewed the Sensor Pad as a Class III medical device requiring premarket approval (PMA).
- Inventive Products submitted a PMA application that the FDA found incomplete or insufficient, but the company continued distributing the product in interstate commerce.
- The United States seized 25 cases of the Sensor Pad inventory and pursued an in rem forfeiture action on the ground that the goods were adulterated devices in interstate commerce.

## Issues

1. Whether the Sensor Pad is a “device” under 21 U.S.C. § 321(h)(2) as an article intended for use in the diagnosis of disease.
2. Whether a product intended to assist lay “screening” through self-examination falls outside “diagnosis” for purposes of the FDCA device definition.
3. Whether, given its Class III status and lack of an approved/complete PMA, the seized Sensor Pads were adulterated and subject to condemnation.

## Decision

- The Seventh Circuit affirmed summary judgment for the United States and upheld condemnation of the seized inventory.
- The court held the Sensor Pad is a “device” under 21 U.S.C. § 321(h)(2) because it is intended to aid detection of disease.
- The court rejected the argument that “screening” is meaningfully distinct from “diagnosis” under the statute for excluding the product from regulation.
- Because the Sensor Pad was a “new” Class III device lacking effective PMA and still marketed, it was adulterated under 21 U.S.C. § 351(f)(1)(A) and subject to forfeiture.

## Legal Principles

- The FDCA’s “device” definition includes articles intended for use in the diagnosis of disease; tools that materially assist detection or early recognition may qualify even if they do not yield a definitive physician diagnosis.
- “Screening” for disease through a product’s intended detection-related use can fall within “diagnosis of disease” under 21 U.S.C. § 321(h)(2).
- Courts give substantial weight to the FDA’s reasonable, consistent interpretation of ambiguous terms within the agency’s regulatory authority, including what constitutes a diagnostic device.
- A “new” Class III device marketed without an approved (or sufficiently complete) PMA is adulterated under 21 U.S.C. § 351(f)(1)(A), supporting seizure and condemnation when introduced into interstate commerce.

## Conclusion

The court treated a breast self-examination aid as a diagnostic-related medical device under the FDCA, deferred to the FDA’s classification, and upheld forfeiture because the Class III product was marketed without an effective PMA, making it adulterated as a matter of law.


United States v. 25 Cases, More or Less, of an Article of Device, 942 F.2d 1179 (7th Cir. 1991)