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

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

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