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Guidance on Infusion Pumps

12/02/2014

Federal Register Notice: FDA is making available 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. It also describes considerations in preparing premarket submissions for infusion pumps and identifies device features that manufacturers should address throughout the total product life cycle. To download this guidance, click here. To view this notice, click here.

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