SoftwareCPR® Mobile App with Regs and Guidance

You can search the app stores for SoftwareCPR® to download on an iPhone or Android. The app provides key FDA regulations and Software Guidances for quick reference and is organized by section. Impress your friends by accessing the exact text of FDA documents wherever you go. We plan to add additional documents over time.

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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