FDA Letter to Infusion Pump Manufacturers

The Food and Drug Administration (FDA) has posted a letter is sent to infusion pump manufacturers as part of a major initiative to enhance infusion pump safety. In this letter FDA mentions software issues as a focus and offers to provide free static analysis of the software. It also strongly recommends early interaction with FDA prior to premarket submissions. The full letter is at the link provided

Upcoming Training

QSS Software Validation
Planned Instructors:  Brian Pate, John Murray
Location: Boston, MA, USA
Dates:  June 2-4, 2020
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