federal_register: 2012-27340

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2012-27340 Draft Guidance for Industry and Food and Drug Administration Staff; Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices." This draft guidance is to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of highly multiplexed microbiological/medical countermeasures in vitro nucleic acid based diagnostic devices (HMMDs) intended to simultaneously detect and identify multiple pathogen nucleic acids extracted from a single appropriate human specimen or culture. This draft guidance is not final nor is it in effect at this time. 2012-11-09 2012 11 https://www.federalregister.gov/documents/2012/11/09/2012-27340/draft-guidance-for-industry-and-food-and-drug-administration-staff-highly-multiplexed https://www.govinfo.gov/content/pkg/FR-2012-11-09/pdf/2012-27340.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices." This draft guidance is to provide industry...

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