FDA Draft Infusion Pump Guidance

The Food and Drug Administration (FDA) has posted a draft revised guidance for infusion pumps. This guidance is part of a major FDA initiative to enhance infusion pump safety. It has many references to software and software hazards. It also indicates an assurance/safety case should be provided rather than just a risk analysis. Although this guidance is for infusion pumps it may be indicative of the FDA’s future expectations for other devices and their software as well.

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