U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. About FDA
  3. Reports, Manuals, & Forms
  4. Reports
  5. Economic Impact Analyses of FDA Regulations
  6. Summary: Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection (Proposed Rule)
  1. Economic Impact Analyses of FDA Regulations

Summary: Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection (Proposed Rule)

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 recommendations of the Microbiology Devices Advisory Panel (the Panel). FDA is also issuing a draft special controls guideline that the Agency believes is necessary to provide a reasonable assurance of the safety and effectiveness of the device. In addition, when final, the rule will establish restrictions on use and distribution of this device.

Regulatory Impact Analysis

Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection (Proposed Rule) (PDF - 44.5KB)

Federal Register: 80 FR 71756, November 17, 2015

Docket: FDA-2011-N-0103

   
Back to Top