Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories
Information
Type
Rule
Regulated products
Medical Devices
Published
May 18, 2018
Last updated
May 18, 2018
Description
Document number 2018-10610. 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).
Tags
Organization
Country / Region
United States
License
Other (Public Domain)