FDA Inspection Issue Terminology

FDA issues Field Management Directives on a number of subjects including #120 483s and #86Estabilishment Inspection Report Conclusions and Decisions. The latter is at the link provided and includes tables definings FDA’s terminology for rating inspectional issues and conclusion.

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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