Medical devices; reclassification of three anesthesiology preamendments class III devices into class II. Final rule.
The Food and Drug Administration (FDA) is reclassifying three anesthesiology preamendments devices from class III (premarket approval) into class II (special controls). FDA is also identifying the special controls that the agency believes will reasonably ensure the safety and effectiveness of the devices. This reclassification is being undertaken on the agency's own initiative based on new information under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 and the FDA Modernization Act of 1997.
D000776:Anesthesiology / Q000145:classification / Q000295:instrumentation*; D001784:Blood Gas Analysis / Q000145:classification / Q000295:instrumentation*; D018795:Device Approval; D004867:Equipment Design; D004869:Equipment Safety; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration