Extensive Part 11 Erecs;esig Warning Letter

The document at the link listed is an excerpt from a warning letter issued to Linweld Inc. on 8/2/99. This excerpt cites Part 11 violations extensively. Its an example of detailed Part 11 enforcement.

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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