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July 12, 2020
This content is only available to our Premium subscribers.  See our Subscribe page for information on subscriptions. You are likely aware of the CAPA process overall and how it fits in to the quality management system for a medical device manufacturer or supplier.  Just the name itself, corrective and preventive action, describes one of the...
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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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