August 30, 2000
Failure to maintain accurate, complete, and current records of device accountability [21 CFR 812.140(b)(2)]. There is no documentation of the number of_____ and _____ manufactured and distributed, the number of copies of the controlling software made, or the disposition of each copy of the software. There are no records showing to which sites the device...
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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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