federal_register: 2016-04411

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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
2016-04411 Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories Proposed Rule The Food and Drug Administration (FDA, Agency, or we) is proposing to classify the blood establishment computer software (BECS) and BECS accessories into class II (special controls). FDA is identifying proposed special controls for BECS and BECS accessories that are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also giving notice that the Agency does not intend to exempt BECS and BECS accessories from premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA is publishing in this document the recommendations of the Blood Product Advisory Committee regarding the classification of these devices. After considering public comments on the proposed classification, FDA will publish a final regulation classifying these device types. 2016-03-01 2016 3 https://www.federalregister.gov/documents/2016/03/01/2016-04411/medical-devices-hematology-and-pathology-devices-classification-of-blood-establishment-computer https://www.govinfo.gov/content/pkg/FR-2016-03-01/pdf/2016-04411.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, Agency, or we) is proposing to classify the blood establishment computer software (BECS) and BECS accessories into class II (special controls). FDA is identifying proposed special controls for BECS and BECS...  

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