Infusion pump tracking
This article was originally published in The Gray Sheet
Disposable infusion pumps will not require tracking under an amendment currently being drafted to FDA's Feb. 19 final tracking guidance, FDA staffers say. The modification would nullify the risk-based differentiation of infusion pumps in the current guidance, which exempts pumps from tracking if they are "designated and labeled for use exclusively for fluids with low potential risks," such as enteral feeding and anti-infectives. Following the amendment, tracking would only be required for electromechanical infusion pumps
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