November 16, 2000
As of 11/15/00 FDA CDRH formally recognizes “ANSI/UL 1998 Software in Programmable Components” for software submissions. Details of the recognition have not yet been posted by FDA as of 11/19/00 but the original intent was for this to be the first software standard to be recognized for devices with software of a MAJOR level of...
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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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