General hospital and personal use devices; premarket approval of the infant radiant warmer--FDA. Proposed rule.
The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the infant radiant warmer, a medical device. The agency is also summarizing its proposed findings regarding: (1) the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements and (2) the benefits to the public from the use of the device. In addition, FDA is announcing an opportunity for interested persons to request the agency to change the classification of the device based on new information.
D004869:Equipment Safety / Q000592:standards*; D006801:Humans; D007186:Incubators, Infant / Q000592:standards*; D007231:Infant, Newborn; D014481:United States; D014486:United States Food and Drug Administration