FDA Retains Three Medical Devices in Class III, Requires Premarket Approval

Summary

The FDA is issuing a final rule to retain three preamendment medical devices in Class III and require premarket approval for the suction antichoke device, tongs antichoke device, and implanted neuromuscular stimulator. The agency is taking this action under the Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997.