FDA Draft Guidance Flow Cytometry Devices

The FDA issued a draft gudance entitled “Flow Cytometric Devices” dated 14-Oct-2014. Section 5 of this guidance addresses softwrae used in the device and discusses regualtory clearance with the associated reagents and instrumentation as well as other information needed. The full guidance is at the link provided and was issues jointly by the Office of In Vitro Diagnositcs Division of Immunology and Hematology and the Center for Biologics Evaluation and Research.

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
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.