FDA Draft Guidance Flow Cytometry Devices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.

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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