federal_register: 2015-21237
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2015-21237 | Medical Devices; Immunology and Microbiology Devices; Classification of Clostridium Difficile Toxin Gene Amplification Assay | Rule | The Food and Drug Administration (FDA) is classifying Clostridium difficile (C. difficile) toxin gene amplification assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. | 2015-08-27 | 2015 | 8 | https://www.federalregister.gov/documents/2015/08/27/2015-21237/medical-devices-immunology-and-microbiology-devices-classification-of-clostridium-difficile-toxin | https://www.govinfo.gov/content/pkg/FR-2015-08-27/pdf/2015-21237.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is classifying Clostridium difficile (C. difficile) toxin gene amplification assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a... |