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2010-09-24
article
Medical Devices; Global Harmonization Task Force; Study Group 1; Working Draft “Medical Devices Classification;” Availability
Notices
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D09002ee1bdf8a934
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
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.
66 FR 27150
https://www.govinfo.gov/app/details/FR-2001-05-16/01-12226
01-12226
fr16my01-123
4160-01-S
Docket No. 01N-0191
https://www.govinfo.gov/app/details/FR-2001-05-16/01-12226
https://www.govinfo.gov/content/pkg/FR-2001-05-16/html/01-12226.htm
https://www.govinfo.gov/content/pkg/FR-2001-05-16/pdf/01-12226.pdf
2 p.
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66 FR 27150
Medical Devices; Global Harmonization Task Force; Study Group 1; Working Draft “Medical Devices Classification;” Availability; Federal Register Vol. 66, Issue
NOTICE
01-12226
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. 01N-0191
4160-01-S
01-12226
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.
Submit written comments concerning this at any time. FDA must submit its comments on this draft to GHTF by July 1, 2001. FDA will consider any comments that it receives after it prepares its comments for GHTF in future discussions with GHTF on this issue.
Kathy M. Poneleit, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-3084.
Reports and guidance documents; availability, etc.:
Medical devices
Medical devices classification,
http://www.fda.gov/cdrh
Federal Register
Vol. 66, no. 95
Office of the Federal Register, National Archives and Records Administration
2001-05-16
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Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2001-05-16
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https://www.govinfo.gov/content/pkg/FR-2001-05-16/xml/FR-2001-05-16.xml
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