E- xmatch FDA Reviewer Checklist

FDA CBER “Computer Cross match reviewers checklist”. We’re not sure of the date of issue of this checklist. It is intended for use by FDA reviewers reviewing blood establishment Blood Bank applications for approval to use electronic cross matching. of primary used to reviewers and to blood establishments it provides blood bank Computer System manufacturers insight into what their customers must provide to obtain approval to use the electronic cross matching features oficomputer systems.

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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