Infusion Pumps Total Product Life Cycle; Guidance for Industry and Food and Drug Administration Staff; Availability

Streszczenie

Food and Drug Administration (FDA) is announcing the availability of the final guidance entitled, "Infusion Pumps Total Product Life Cycle; Guidance for Industry and FDA Staff." The recommendations in this guidance are intended to improve the safety and effectiveness of these devices. This guidance also describes considerations in preparing premarket submissions for infusion pumps and identifies device features that manufacturers should address throughout the total product life cycle.