federal_register: 99-20140
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 99-20140 | Global Harmonization Task Force; Draft Document on Proposal for Reporting of Use Errors with Medical Devices; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a Global Harmonization Task Force (GHTF) draft document entitled ``Proposal for Reporting of Use Errors with Medical Devices.'' The draft guidance includes information for regulatory authorities about reporting of adverse events that result in death or serious injury or certain types of near incidents. This draft document has been prepared by members of the GHTF Study Group 2 (SG2) on Medical Devices Vigilance/Postmarket Surveillance Reporting Systems. The draft document represents a harmonized proposal. Elements of the approach set forth in this draft document may not be consistent with current U.S. regulatory requirements. FDA is requesting comments on this draft document. | 1999-08-05 | 1999 | 8 | https://www.federalregister.gov/documents/1999/08/05/99-20140/global-harmonization-task-force-draft-document-on-proposal-for-reporting-of-use-errors-with-medical | https://www.govinfo.gov/content/pkg/FR-1999-08-05/pdf/99-20140.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a Global Harmonization Task Force (GHTF) draft document entitled ``Proposal for Reporting of Use Errors with Medical Devices.'' The draft guidance includes information for... |