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This content is only available to Premium subscribers.  See our Subscribe page for information on subscriptions. As more "software as a medical device" (SaMD) applications are developed and marketed, there has been an increased focus on what activities and documentation are required for compliance with US medical device regulations and applicable ISO standards.  Along with...
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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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