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# FDA Proposes Blood Establishment Software into Class 2
- URL: https://www.fdaweb.com/fda-proposes-blood-establishment-software-into-class-2/
- Published: 2016-03-01T12:00:00.000Z
- Updated: 2026-09-15T02:39:37.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134931

*Federal Register* Proposed rule: FDA is proposing to classify the blood establishment computer software (BECS) and BECS accessories into Class 2 (special controls). The agency is also giving notice that the it does not intend to exempt BECS and BECS accessories from premarket notification requirements of the the FD&C Act. It is also publishing in this document the recommendations of the Blood Product Advisory Committee on the classification of these devices. To view this proposed rule, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-03-01/pdf/2016-04411.pdf?ref=fdaweb.com)