$SoftwareCPR Premarket Submission Presentation $

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Slides from a presentation by Molly Ray of SoftwareCPR are at the link provided as a pdf. These slides provide an introduction to pre-market submissions for devices that are, or contain, software.

SoftwareCPR Presentation-510k

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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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