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2017-01-06
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Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh
Rules and Regulations
D09002ee1bdbfc9cd
D09002ee1bdbfca2d
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 the Agency) is reclassifying surgical instrumentation for use with urogynecologic surgical mesh from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and identifying them as ``specialized surgical instrumentation for use with urogynecologic surgical mesh.'' FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information.
82 FR 1598
https://www.govinfo.gov/app/details/FR-2017-01-06/2016-31862
2016-31862
fr06ja17-3
4164-01-P
Docket No. FDA-2014-N-0297
https://www.govinfo.gov/app/details/FR-2017-01-06/2016-31862
https://www.govinfo.gov/content/pkg/FR-2017-01-06/html/2016-31862.htm
https://www.govinfo.gov/content/pkg/FR-2017-01-06/pdf/2016-31862.pdf
Medical Devices
6 p.
1598
1603
82 FR 1598
Code of Federal Regulations
Title 21 Part 884
21 CFR Part 884
Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh; Federal Register Vol. 82, Issue
RULE
2016-31862
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2017-01-06
Docket No. FDA-2014-N-0297
4164-01-P
2016-31862
Final order.
The Food and Drug Administration (FDA or the Agency) is reclassifying surgical instrumentation for use with urogynecologic surgical mesh from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and identifying them as ``specialized surgical instrumentation for use with urogynecologic surgical mesh.'' FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information.
This order is effective January 6, 2017. See further discussion in section V, ``Implementation Strategy.''
Sharon Andrews, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. G110, Silver Spring, MD 20993, 301-796-6529, Sharon.Andrews@fda.hhs.gov.
Medical Devices
Medical Devices:
Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh
,
Sharon.Andrews@fda.hhs.gov
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM487224.pdf
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM490205.pdf
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/UCM491862.pdf
https://www.regulations.gov
Federal Register
Vol. 82, no. 4
Office of the Federal Register, National Archives and Records Administration
2017-01-06
continuing
daily
deposited
born digital
610 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2017-01-06
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https://www.govinfo.gov/app/details/FR-2017-01-06
https://www.govinfo.gov/content/pkg/FR-2017-01-06/pdf/FR-2017-01-06.pdf
https://www.govinfo.gov/content/pkg/FR-2017-01-06/xml/FR-2017-01-06.xml
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DGPO
2017-01-06
2023-04-28
FR-2017-01-06
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FR-2017-01-06
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