Food and Drug Administration--General hospital and personal use devices; general provisions. Final rule.
Food and Drug Administration [FDA] is issuing a final rule regarding general provisions applicable to the classification of general hospital and personal use devices. The preamble to this rule responds to general comments received on the proposals regarding classification of general hospital and personal use devices. This action is being taken under the Medical Device Amendments of 1976.
D004865:Equipment and Supplies, Hospital / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000458:organization & administration