March 6, 1997
Medical Information Technology 3/6/97 Blood Bank Software Manufacturer c. Quality Assurance audits do not cover any quality assurance activities associated with the software customization program. 4. Failure to establish an adequate complaint handling program for the [purged text] as required by 21 CFR 820.198 in that complaints are not reviewed by a formally designated unit...
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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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