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.

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Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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