federal_register: 2015-27197

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2015-27197 Medical Devices; Immunology and Microbiology Devices; Classification of Autosomal Recessive Carrier Screening Gene Mutation Detection System Rule The Food and Drug Administration (FDA) has classified an autosomal recessive carrier screening gene mutation detection system into class II (special controls). The special controls that apply to this device are identified in this order and will be part of the codified language for the autosomal recessive carrier screening gene mutation detection system classification. The Agency has classified the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. 2015-10-27 2015 10 https://www.federalregister.gov/documents/2015/10/27/2015-27197/medical-devices-immunology-and-microbiology-devices-classification-of-autosomal-recessive-carrier https://www.govinfo.gov/content/pkg/FR-2015-10-27/pdf/2015-27197.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) has classified an autosomal recessive carrier screening gene mutation detection system into class II (special controls). The special controls that apply to this device are identified in this order and will be part...  

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