FDA CDRH 510(k) Urea Nitrogen Test System

“Guidance for Industry In Vitro Diagnostic Urea Nitrogen Test System”

This document was issued on July 6, 1998. It has a short section on software information where it requires validation information and a certification information in the submission. In section III on specific performance characteristics it talks about performance data to be provided in the submission in terms of method comparison, the statistics, percision information and linearity. Although it does not specifically state software in this section, certainley software is involved in the data aquisition and calculations and relevant to coming up with this performance information.

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

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