federal_register: 2018-10610

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2018-10610 Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories Rule The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to classify blood establishment computer software (BECS) and BECS accessories (regulated under product code MMH) into class II (special controls). FDA has identified 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 (FD&C Act). 2018-05-18 2018 5 https://www.federalregister.gov/documents/2018/05/18/2018-10610/medical-devices-hematology-and-pathology-devices-classification-of-blood-establishment-computer https://www.govinfo.gov/content/pkg/FR-2018-05-18/pdf/2018-10610.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to classify blood establishment computer software (BECS) and BECS accessories (regulated under product code MMH) into class II (special controls). FDA has identified special...

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