Part 11 Presentation by Paul Motise of FDA

Presentation slides for “Part 11:Electronic Records; Electronic Signatures Answers to Frequently Asked Questions” given by Paul Motise in January of 1999. Paul transferred to the FDA’s Office of Regulatory Affairs from CDER during 1999 and is leading inspector training and enforcement efforts for this rule.

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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