Day

March 19, 1997
Fischer Imaging Corporation 3/19/97 X-ray and mammography systems (a) At least [purged word] systems observed with in-process component and system mis-assemblies such as miswired parts; incorrect or defective printed circuit boards (PCB); missing hardware; defective computer or monitor; incorrect labeling; and defective components such as hand switches, foot switches, collimators, radiation detectors, x-ray tube, cables,...
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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:  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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