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2018-11-14
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Medical Devices; Exemptions From Premarket Notification: Class II Devices
Notices
D09002ee1bdbbe769
D09002ee1bdbbe7e6
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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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing a list of class II devices that the Agency has determined based on established factors to no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations. FDA is publishing this notice of that determination in accordance with procedures established by the 21st Century Cures Act. This notice represents FDA's final determination with respect to the list of class II devices proposed in a March 14, 2017, Federal Register document. The exemptions in this notice will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.
82 FR 31976
https://www.govinfo.gov/app/details/FR-2017-07-11/2017-14453
2017-14453
fr11jy17-73
4164-01-P
Docket No. FDA-2017-N-1129
https://www.govinfo.gov/app/details/FR-2017-07-11/2017-14453
https://www.govinfo.gov/content/pkg/FR-2017-07-11/html/2017-14453.htm
https://www.govinfo.gov/content/pkg/FR-2017-07-11/pdf/2017-14453.pdf
27 p.
31976
32002
82 FR 31976
Medical Devices; Exemptions From Premarket Notification: Class II Devices; Federal Register Vol. 82, Issue
NOTICE
2017-14453
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2017-N-1129
4164-01-P
2017-14453
Notice.
The Food and Drug Administration (FDA or Agency) is announcing a list of class II devices that the Agency has determined based on established factors to no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations. FDA is publishing this notice of that determination in accordance with procedures established by the 21st Century Cures Act. This notice represents FDA's final determination with respect to the list of class II devices proposed in a March 14, 2017, Federal Register document. The exemptions in this notice will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.
Bryce Bennett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, email: Gregory.Bennett@fda.hhs.gov.
Medical Devices:
Exemptions from Premarket Notification; Class II Devices
,
Gregory.Bennett@fda.hhs.gov
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf
https://www.regulations.gov
Federal Register
Vol. 82, no. 131
Office of the Federal Register, National Archives and Records Administration
2017-07-11
continuing
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245 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2017-07-11
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0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr11jy17
https://www.govinfo.gov/app/details/FR-2017-07-11
https://www.govinfo.gov/content/pkg/FR-2017-07-11/pdf/FR-2017-07-11.pdf
https://www.govinfo.gov/content/pkg/FR-2017-07-11/xml/FR-2017-07-11.xml
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2018-11-14
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FR-2017-07-11
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eng
FR
FR-2017-07-11
82
131