FDA CDRH 510(k) External Infusion Pumps

“Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion Pumps”

This document was issued in draft form in August of 1994. Section II.G requires a hazard analysis and references the now obsolete reviewer guidance document for computer controlled medical devices, “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review,” the current FDA software submission guidance, “Guidance for theContent of Premarket Submissions for Software Contained in MEdical Devices,” should be used in place of the obolete document referenced.

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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