federal_register: 2020-21463
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020-21463 | Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use." This guidance describes studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems (BGMSs) that are for prescription point-of-care use. | 2020-09-29 | 2020 | 9 | https://www.federalregister.gov/documents/2020/09/29/2020-21463/blood-glucose-monitoring-test-systems-for-prescription-point-of-care-use-guidance-for-industry-and | https://www.govinfo.gov/content/pkg/FR-2020-09-29/pdf/2020-21463.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use." This guidance describes studies and information that FDA recommends... |