federal_register: E8-31213

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E8-31213 Medical Devices; Immunology and Microbiology Devices; Classification of Enterovirus Nucleic Acid Assay Rule The Food and Drug Administration (FDA) is classifying enterovirus nucleic acid assay into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA" (ribonucleic acid). The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device. 2009-01-02 2009 1 https://www.federalregister.gov/documents/2009/01/02/E8-31213/medical-devices-immunology-and-microbiology-devices-classification-of-enterovirus-nucleic-acid-assay https://www.govinfo.gov/content/pkg/FR-2009-01-02/pdf/E8-31213.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is classifying enterovirus nucleic acid assay into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document:...

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