Opportunity to request change in classification of continuous ventilator--FDA. Notice; final rule-related.
The Food and Drug Administration (FDA) is issuing this notice to allow interested persons an opportunity to submit a request for a change in the classification of the continuous ventilator based on new information relevant to the classification of the device. If FDA receives no request for a change in classification or if FDA receives a request but denies it, the agency will proceed to develop a performance standard for this device. FDA also is announcing its intent to publish in the Federal Register in the near future additional notices of this type for several other generic types of devices.
D004865:Equipment and Supplies, Hospital / Q000592:standards; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration; D012122:Ventilators, Mechanical / Q000592:standards*