# Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories
> **Food and Drug Administration** · Final rule. · Published 2018-05-18 · Effective 2018-06-18 · 83 FR 23212
## Document
- **Document number:** 2018-10610
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 83 FR 23212
- **CFR reference:** 21 CFR 864
- **Publication date:** 2018-05-18
- **Effective date:** 2018-06-18
- **HHS docket:** Docket No. FDA-2016-N-0406
## Abstract

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).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2018/05/18/2018-10610/medical-devices-hematology-and-pathology-devices-classification-of-blood-establishment-computer)
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