21 CFR Part 11 Selected References

This topic contains selected references for electronic records and signatures compliance. It is NOT an exhaustive set and MORE can be found by searching the document library on this website. Paid subscribers have access to all items listed while others have limited access. Other training aides may be provided to paid subscribers on request if they can not find what they are looking for on the site and if we have them available.

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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