FDA CDRH OSEL Software Analysis Tools

Brian Fitzgerald Deputy Division Director, Division of Electrical and Software Engineering, FDA CDRH, Office of Science & Engineering Laboratories, provided a list of software analysis tools FDA’s laboratory uses in evaluating medical device code. This was in response to a question posed at a recent AAMI Webinar that John Murray of FDA and Alan Kusinitz of SoftwareCPR presented.

FDA OSEL is using the following static analysis tools to a greater or lesser extent depending on the specific situation;
Polyspace C and C++
Ensure++
Coverity
Codesonar
Codesurfer
OSEL is also using a dynamic analysis tool which has some static analysis capabilities called LDRA.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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