Medical devices; gastroenterology and urology devices; classification of the electrogastrography system. Food and Drug Administration, HHS. Final rule.
The Food and Drug Administration (FDA) is classifying the electrogastrography system (EGG) into class II (special controls). The special controls that will apply to the EGG system are restriction to prescription use, certain labeling requirements, design requirements, and data collection requirements. The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the 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. The agency is classifying the EGG system into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
D018795:Device Approval; D004864:Equipment and Supplies / Q000145:classification*; D005762:Gastroenterology / Q000145:classification / Q000295:instrumentation*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration