FDA CDRH 510(k) Creatinine Test System

“Guidance for Industry In Vitro Diagnostic Creatinine Test System”

This guidance was issued July 2, 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

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

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.