federal_register: 01-12226
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 01-12226 | Medical Devices; Global Harmonization Task Force; Study Group 1; Working Draft “Medical Devices Classification;” Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of the draft document entitled "Medical Devices Classification." Study Group 1 of the Global Harmonization Task Force (GHTF) has prepared this document on premarket regulation of medical devices. This document is intended to provide information only and represents a harmonized proposal that may be used by governments developing or updating their premarket regulation schemes for medical devices. This draft document is not being issued as an FDA guidance. Elements of the approach set forth in this document may not be consistent with current U.S. regulatory requirements. However, FDA is publishing the draft at this time to give the public an opportunity to comment on the document before the agency resumes discussions with other countries. Public comments will help FDA decide whether and how the agency can adapt these recommendations to our own regulatory requirements. | 2001-05-16 | 2001 | 5 | https://www.federalregister.gov/documents/2001/05/16/01-12226/medical-devices-global-harmonization-task-force-study-group-1-working-draft-medical-devices | https://www.govinfo.gov/content/pkg/FR-2001-05-16/pdf/01-12226.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of the draft document entitled "Medical Devices Classification." Study Group 1 of the Global Harmonization Task Force (GHTF) has prepared this document on premarket regulation of... |