federal_register: 2011-29937

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2011-29937 Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices; Public Meeting; Reopening of Comment Period Notice 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. 2011-11-21 2011 11 https://www.federalregister.gov/documents/2011/11/21/2011-29937/advancing-regulatory-science-for-highly-multiplexed-microbiologymedical-countermeasure-devices https://www.govinfo.gov/content/pkg/FR-2011-11-21/pdf/2011-29937.pdf Health and Human Services Department; Food and Drug Administration 221,199 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...

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