Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection
Information
Type
Proposed Rule
Regulated products
IVDMD
Published
November 17, 2015
Last updated
November 17, 2015
Description
Document number 2015-29275. The Food and Drug Administration (FDA) is re-proposing to classify in vitro diagnostic devices for Bacillus species (spp.) detection into class II (special controls) after considering, among other information, the recommendations of the Microbiology Devices Advisory Panel (the Panel). FDA is re-proposing to establish special controls in a draft special controls guideline that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the devices. In addition, FDA is re-proposing to restrict use and distribution of the devices. FDA is publishing in this proposed rule the recommendations of the Panel regarding the classification of the devices.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)