2nd FDA video conference on Part 11

FDA’s biologic division sponsored the second video conference on 21 CFR 11 Electronic Records;electronic signatures on October 21, 1999. Speakers included Paul Motise, Christine Nelson and other FDA experts on this rule. FDA made available a videotape of this conference. Click on the link provided for ordering information direct from their provider. Subscribers to SoftwareCPR.com and consulting clients of SoftwareCPR may request a free loaner copy of the tape from our online store.

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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