November 12, 1999
Failure to validate the EtO sterilization process for ATI plasma exchange tubing setsand off-the-shelf software for compiling clinical trial data. Also there are no procedures established and maintained for monitoring and controlling the process parameters for the ATI plasma exchange tubing sets to ensure that specified requirements are met as required by 21 CFR 820.75....
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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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