Microbiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection
Information
Type
Proposed Rule
Regulated products
IVDMD
Published
May 18, 2011
Last updated
May 18, 2011
Description
Document number 2011-12088. The Food and Drug Administration (FDA) is proposing to classify in vitro diagnostic devices for Bacillus species (spp). detection into class II (special controls), in accordance with the recommendation of the Microbiology Devices Advisory Panel (the Panel). In addition, the proposed rule would establish as a special control limitations on the distribution of this device. FDA is publishing in this document the recommendations of the Panel regarding the classification of this device. After considering public comments on the proposed classification, FDA will publish a final regulation classifying this device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability for comment of the draft guidance document that FDA proposes to designate as a special control for this device.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)