## Facts

- Norman Lake invented a nose clip called the “Inductive Nasal Device” (IND) and claimed it could cure colds and allergies.
- In 1979, Lake sought authorization from the Food and Drug Administration (FDA) to market the IND.
- Under the Food, Drug, and Cosmetic Act (FDCA) medical-device framework, the IND was automatically classified as a Class III device.
- Because it was Class III, the IND could be marketed only if the FDA granted a premarket-approval application (PMA).
- Lake submitted a PMA for the IND.
- The FDA denied the PMA because there were no clinical trials for the IND and the FDA was not persuaded that the IND was an effective cold and allergy treatment.
- After the PMA denial, Lake petitioned the FDA to reclassify the IND as a Class I device.
- Under the FDCA, Class I includes (1) devices for which general statutory controls provide reasonable assurance of safety and effectiveness, or (2) devices for which there is insufficient information to determine whether those controls provide such assurance, so long as the device is not intended to support or sustain human life and does not present a potential unreasonable risk of illness or injury.
- The FDA denied Lake’s reclassification petition, taking the position that the lack of scientific evidence about safety and effectiveness itself indicated a potential unreasonable risk.
- Lake sued in federal district court to challenge the FDA’s denial of reclassification, and the FDA moved for summary judgment.

## Issues

1. Whether the FDCA permits FDA to reclassify a device as Class I when the device’s safety and effectiveness have not been shown through adequate scientific evidence, based on the proponent’s claim that the device is not unreasonably risky.
2. Whether the FDA acted lawfully (and not arbitrarily or capriciously under APA review) in denying reclassification on the ground that the absence of adequate scientific evidence can constitute a potential unreasonable risk of illness or injury.

## Decision

- The court granted summary judgment for the FDA.
- The court upheld the FDA’s denial of Lake’s petition to reclassify the IND from Class III to Class I.
- The court accepted the FDA’s view that, for a device marketed with therapeutic claims, a lack of reliable scientific evidence regarding safety and effectiveness may itself amount to a potential unreasonable risk that bars Class I classification.

## Legal Principles

- Under the FDCA medical-device scheme, Class III devices generally require FDA premarket approval before they may be marketed.
- Class I classification is limited to devices for which general controls provide reasonable assurance of safety and effectiveness, or for which there is insufficient information to make that determination, provided the device is not life-sustaining and does not pose a potential unreasonable risk of illness or injury.
- FDA may treat the absence of adequate scientific evidence supporting a device’s claimed therapeutic effects as relevant to whether the device poses a potential unreasonable risk for classification purposes.
- A court reviewing FDA’s classification decision applies deferential APA review and will uphold the agency when its decision reflects a rational application of statutory criteria to the record.
- Summary judgment is appropriate where the dispute turns on the legality of the agency’s decision rather than on genuinely contested material facts.

## Conclusion

The court upheld the FDA’s refusal to reclassify Norman Lake’s Inductive Nasal Device as a Class I device, agreeing that the agency could view the lack of adequate scientific evidence of safety and effectiveness as creating a potential unreasonable risk that prevents Class I treatment and granting summary judgment to the FDA.


Lake v. FDA, 1989 WL 71554 (1989)