Infusion Pumps Total Product Life Cycle Guidance for Industry and FDA Staff December 2014

GUIDANCE DOCUMENT

• Docket Number: FDA-2010-D-0194
• Issued by: Center for Devices and Radiological Health

FDA has developed this guidance document to assist industry in preparing premarket submissions for infusion pumps and to identify device features that manufacturers should address throughout the total product life cycle. Infusion pumps, as described in 21 CFR 880.5725, are intended for use in a health care facility to pump fluids into a patient in a controlled manner.

The recommendations in this guidance are intended to improve the quality of infusion pumps in order to reduce the number of recalls and adverse events associated with their use. The FDA believes that these recommendations will help mitigate current risk and reduce future risk associated with infusion pumps.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in Agency guidances means that something is suggested or recommended, but not required.

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