federal_register: E9-25315

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
E9-25315 Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Cardiac Allograft Gene Expression Profiling Test Systems Rule The Food and Drug Administration (FDA) is announcing the classification of cardiac allograft gene expression profiling test systems 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: Cardiac Allograft Gene Expression Profiling Test Systems." FDA classified 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. 2009-10-21 2009 10 https://www.federalregister.gov/documents/2009/10/21/E9-25315/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-cardiac https://www.govinfo.gov/content/pkg/FR-2009-10-21/pdf/E9-25315.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the classification of cardiac allograft gene expression profiling test systems into class II (special controls). The special control that will apply to the device is the guidance document entitled...

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