About this document
Infusion Pump Premarket Notification Guidance by Matteo Ageno is a document available to read on EtoBox.
FDA has developed this guidance document to assist industry in preparing premarket notification submissions for infusion pumps and to identify device features that manufactures should address throughout the total product life cycle. The device, as defined in 21 CFR 880.5725, is intended for use in a health care facility to pump fluids into a patient in a controlled manner.1 The recommendations in this guidance are intended to improve the quality of infusion pumps in order to reduce the number of recalls an
- Author
- Matteo Ageno
- Language
- EN