## Facts

- Federal medical-device law classifies devices into Classes I–III based on the level of regulation needed to provide reasonable assurance of safety and effectiveness.
- Devices previously regulated as “new drugs” became “transitional” Class III devices, subject to later reclassification only upon “valid scientific evidence” of safety and effectiveness.
- Soft contact lenses had been treated as new drugs before the statutory amendments and thus became transitional Class III devices.
- Rigid gas permeable (RGP) lenses share characteristics of hard and soft lenses and were treated as transitional Class III devices, requiring premarket approval (PMA) before marketing.
- The FDA proposed reclassifying RGP lenses to a less restrictive class, but later withdrew that proposal by published order, leaving RGP lenses in Class III.
- The Contact Lens Manufacturers Association petitioned for review, arguing the FDA unjustifiably rejected clinical studies and failed to recognize the safety and effectiveness of RGP lenses already on the market.

## Issues

1. Whether the FDA had statutory authority and discretion to withdraw its reclassification proposal and keep RGP lenses as transitional Class III devices.
2. Whether the FDA’s decision and treatment of the scientific record were arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.

## Decision

- The court denied the petition for review and affirmed the FDA’s order.
- The court held the FDA acted within its discretion under the transitional-device provisions in maintaining Class III status for RGP lenses.
- The court concluded the FDA’s determination that the record lacked “valid scientific evidence” supporting class-wide reclassification was rational and adequately explained.
- The court deferred to the FDA’s scientific judgment that variations among RGP lenses (materials, designs, manufacturing processes) limited the generalizability of existing studies.
- The court held the agency’s change in evaluation of prior studies was permissible because the FDA explained why it no longer found the evidence sufficient for generic reclassification.

## Legal Principles

- A transitional medical device may remain in Class III until the FDA concludes, based on “valid scientific evidence,” that safety and effectiveness can be reasonably assured under less stringent controls.
- Courts give substantial deference to the FDA’s scientific and technical judgments in device-classification decisions when the agency explains its reasoning and stays within statutory bounds.
- Under arbitrary-and-capricious review, an agency may reassess the weight or applicability of existing evidence; a change in position is lawful if accompanied by a reasoned explanation grounded in the record.
- The FDA may require product-specific PMA evidence for Class III devices when class-wide evidence is insufficient to support reclassification.

## Conclusion

The D.C. Circuit upheld the FDA’s withdrawal of its proposed reclassification and its decision to keep RGP contact lenses in Class III, finding the agency’s evidence-based assessment of the scientific record reasonable and not arbitrary or capricious.


Contact Lens Mfrs. Ass’n v. Food & Drug Admin., 766 F.2d 592 (D.C. Cir. 1985)