A guidance document titled, "Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices" has recently been posted.
This document recommends studies for establishing the performance characteristics of HMMDs.
FDA considers these recommended studies to be relevant for premarket notifications (e.g., 510(k) or de novo) that may be required for a particular device.
To view the guidance, please CLICK HERE
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