Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories
fda-device · Food and Drug Administration · Rule · Published 2018-05-18 · Effective 2018-06-18 · 83 FR 23212
Document
Document number
2018-10610
Federal Register citation
83 FR 23212
CFR reference
21 CFR 864
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
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).