Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices; Public Meeting; Reopening of Comment Period

The Food and Drug Administration (FDA) is reopening the comment period for the notice announcing a public meeting for the "Advancing Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices" that published in the Federal Register of August 8, 2011 (76 FR 48169). In the notice, FDA requested public comments regarding matters to be discussed at the October 13, 2011, meeting, including the performance evaluation of highly multiplexed microbiology/medical countermeasure (MCM) devices, their clinical application and public health/clinical needs, and quality criteria for establishing the accuracy of reference databases. FDA is reopening the comment period to receive comment updates or any new information on the concept paper entitled "Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices," for FDA's proposed evaluation approach for assessing the performance of highly multiplexed microbiology/MCM devices.