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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.