FDA John Murray Software Training & Part 11 Update

The link provided contains a pdf of a presentation prepared by FDA’s Device Center Software Compliance and Part 11 Expert. It is an update on the status of revision of the Part 11 regulation as of November 2007 and also an overview of the newly developed internal training on software regulation that John teaches to FDA staff. This information was publicly presented at an AAMI Webinar in December.

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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