Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories
Information
Type
Proposed Rule
Regulated products
Medical Devices
Published
March 1, 2016
Last updated
March 1, 2016
Description
Document number 2016-04411. The Food and Drug Administration (FDA, Agency, or we) is proposing to classify the blood establishment computer software (BECS) and BECS accessories into class II (special controls). FDA is identifying proposed 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 FD&C Act). FDA is publishing in this document the recommendations of the Blood Product Advisory Committee regarding the classification of these devices. After considering public comments on the proposed classification, FDA will publish a final regulation classifying these device types.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)