June 30, 1999
Prucka 30-June-99 Multi-channel electrocardiographic amplifiers, CardioLab EP System and CardioCath Catheterization Lab System software 2. Failure to establish and maintain procedures for validation of the device design, including software validation, and documentation of the validation, as required by 21 CFR 820.30(g). For example: a. Standard operating procedures have not been established for software validation. b....
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30-June-99 C30-June-99 Kavo Dental 7 units. Class III. AC powered dental drilling device. Software error may cause unit to shutdown prior to reaching preset torque limit. Z-1215-9
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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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