June 22, 2000
Failure to establish and maintain procedures for validating the device design to include validation and to perform design validation under defined operating conditions on initial production units, lots, or batches, or their equivalents; and failure to ensure that devices conform to defined user needs and intended uses and to include testing of production units under...
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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:

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