FDA CDRH 510(k) Sodium Test System

“Guidance for Industry In Vitro Diagnostic Sodium Test System.”

This guidance was issued July 6, 1998. Like other guidance documents related to IVD tests issued in this time frame, there is a short software section that requires software validation information and a certification statement in the submission. And there is a section on other device validaton information related to the methods and percision and liniarity and the statisics and calculations involved.

SoftwareCPR Keyword: IVD

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