General hospital and personal use devices; classification of the Apgar timer, lice removal kit, and infusion stand--FDA. Proposed rule.
The Food and Drug Administration (FDA) is proposing to classify the Apgar timer, lice removal kit, and infusion stand into class I. FDA is also publishing the recommendations of the General Hospital and Personal Use Devices Panel (the panel) regarding the classification of the devices. After considering public comments on the proposed classification, FDA will publish a final regulation classifying the devices. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA).
D000818:Animals; D001034:Apgar Score; D003257:Consumer Product Safety; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D006801:Humans; D007231:Infant, Newborn; D007262:Infusions, Intravenous / Q000295:instrumentation; D007300:Insect Control / Q000295:instrumentation; D008003:Phthiraptera; D014481:United States; D014486:United States Food and Drug Administration