Medical devices; invitation for offers to submit or to develop a performance standard for cardiac monitor (including cardiotachometer and rate alarm)--FDA. Notice of inquiry.
The Food and Drug Administration (FDA) is issuing this notice to invite interested persons, including any Federal agency, to submit any existing standard as a proposed performance standard for the cardiac monitor (including cardiotachometer and rate alarm) for use in measuring heart rate, or to submit an offer to develop such a proposed standard. If FDA does not receive any response to this notice, or receives a response to but does not accept any existing standard or offer to develop a standard, the agency will proceed to develop a performance standard or take other appropriate action to facilitate the development of a performance standard for the device.
D004562:Electrocardiography / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D008991:Monitoring, Physiologic / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration