federal_register: 2014-12545
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2014-12545 | Medical Devices; Immunology and Microbiology Devices; Classification of Dengue Virus Serological Reagents | Rule | The Food and Drug Administration (FDA) is classifying dengue virus serological reagents into class II (special controls). The special controls that will apply to the device are identified in this order, and the codified language for the dengue serological reagents classification will include the identification of the special controls that will apply to this device. The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device. | 2014-05-30 | 2014 | 5 | https://www.federalregister.gov/documents/2014/05/30/2014-12545/medical-devices-immunology-and-microbiology-devices-classification-of-dengue-virus-serological | https://www.govinfo.gov/content/pkg/FR-2014-05-30/pdf/2014-12545.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is classifying dengue virus serological reagents into class II (special controls). The special controls that will apply to the device are identified in this order, and the codified language for the dengue... |