United States Government Publishing Office
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Regulatory Information
2014_register
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2014-03-25
article
Medical Device Classification Procedures
Proposed Rules
D09002ee1bdc64e62
D09002ee1bdc64f32
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is proposing to amend its regulations governing classification and reclassification of medical devices to conform to the applicable provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA is also proposing changes unrelated to the new FDASIA requirements to update its regulations governing classification and reclassification of medical devices. FDA is taking this action to codify the procedures and criteria that apply to classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation.
79 FR 16252
https://www.govinfo.gov/app/details/FR-2014-03-25/2014-06364
2014-06364
fr25mr14-24
4160-01-P
Docket No. FDA-2013-N-1529
https://www.govinfo.gov/app/details/FR-2014-03-25/2014-06364
https://www.govinfo.gov/content/pkg/FR-2014-03-25/html/2014-06364.htm
https://www.govinfo.gov/content/pkg/FR-2014-03-25/pdf/2014-06364.pdf
Administrative Practice and Procedure
Medical Devices
14 p.
16252
16265
79 FR 16252
Code of Federal Regulations
Title 21 Part 860
21 CFR Part 860
Medical Device Classification Procedures; Federal Register Vol. 79, Issue
PRORULE
2014-06364
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2014-06-23
Docket No. FDA-2013-N-1529
4160-01-P
2014-06364
Proposed rule.
The Food and Drug Administration (FDA) is proposing to amend its regulations governing classification and reclassification of medical devices to conform to the applicable provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA is also proposing changes unrelated to the new FDASIA requirements to update its regulations governing classification and reclassification of medical devices. FDA is taking this action to codify the procedures and criteria that apply to classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation.
Submit either electronic or written comments on the proposed rule by June 23, 2014. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by April 24, 2014.
Marjorie Shulman, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1536, Silver Spring, MD 20993, 301-796- 6572; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-6210.
Administrative Practice and Procedure
Medical Devices
Medical Device Classification Procedures
,
oira_submission@omb.eop.gov
http://www.regulations.gov
Federal Register
Vol. 79, no. 57
Office of the Federal Register, National Archives and Records Administration
2014-03-25
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488 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2014-03-25
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https://www.govinfo.gov/content/pkg/FR-2014-03-25/xml/FR-2014-03-25.xml
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