Medical devices; invitation for offers to submit or to develop a performance standard for breathing frequency monitor (neonatal apnea monitor)--FDA. Proposed rule.
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 breathing frequency monitor intended for use on infants (also called the neonatal apnea monitor), 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 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.
D001049:Apnea / Q000628:therapy*; D004864:Equipment and Supplies / Q000592:standards*; D006761:Hospitals; D006801:Humans; D007231:Infant, Newborn; D008991:Monitoring, Physiologic / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration