federal_register: 2016-14459
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 | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2016-14459 | Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non-Quantitative) Test System in a Reagent Tablet Format; Republication | Notice | The Food and Drug Administration (FDA) is republishing in its entirety a notice entitled "Medical Devices; Exemption from Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non- Quantitative) Test System in a Reagent Tablet Format" that published in the Federal Register on May 4, 2016 (81 FR 26802). FDA is republishing to correct an inadvertent error in the Docket Number and to announce a revised comment period. FDA is announcing that it has received a petition requesting exemption from the premarket notification requirements for a method, metallic reduction, glucose (urinary, non-quantitative) test system in a reagent tablet format that is intended to measure glucosuria (glucose in urine). Method, metallic reduction, glucose (urinary, non-quantitative) test systems in a reagent tablet format are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA). | 2016-06-20 | 2016 | 6 | https://www.federalregister.gov/documents/2016/06/20/2016-14459/medical-devices-exemption-from-premarket-notification-method-metallic-reduction-glucose-urinary | https://www.govinfo.gov/content/pkg/FR-2016-06-20/pdf/2016-14459.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is republishing in its entirety a notice entitled "Medical Devices; Exemption from Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Non- Quantitative) Test System in a Reagent Tablet Format"... |