Regulatory Controls Over Software Used in Blood Establishment | FDA
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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). This rule is effective June 18, 2018. 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).
The purpose is that FDA is classifying BECS and BECS accessories into class II (special controls). The Agency believes that the special controls established and imposed by this final rule, together with the general controls, will provide reasonable assurance of the safety and effectiveness of these devices. In this final rule, FDA is also revising the definition of BECS accessories from the definition in the proposed rule and responding to comments received on the proposed rule. Lastly, FDA is giving notice that the Agency does not intend to exempt BECS and BECS accessories from the premarket notification requirements of the FD&C Act.
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