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Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories (Final Rule) Regulatory Impact Analysis

The Food and Drug Administration is issuing a final rule to classify blood establishment computer software (BECS) and BECS accessories 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.

The special controls for these devices are necessary to provide a reasonable assurance of safety and effectiveness. Between 1996 and the time that FDA drafted the proposed rule in December 2015, FDA had cleared 220 BECS and BECS accessories under the 510(k) program, consistent with the recommendations in the FDA guidance, “Guidance for Industry and FDA Staff; Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” issued May 11, 2005. As current practice and as outlined in this guidance, manufacturers already conform to the risk mitigations that have been proposed as special controls for BECS and BECS accessories.  This rule would essentially formalize current practice and will not result in any additional associated costs. Likewise, this classification will not result in any significant changes in how 510(k) premarket notifications for the affected devices are submitted or prepared by manufacturers or in how they are reviewed by FDA. Therefore, compliance with the special controls for this device would not yield significant new costs for affected manufacturers.  Because the classification of these devices to Class II (special controls) would not impose significant new obligations on manufacturers, the Agency concludes that the rule will impose no additional regulatory burdens.

Federal Register: 83 FR 23212, May 18, 2018

Docket: FDA-2016-N-0406