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2019-10-10
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Intravascular Catheters, Wires, and Delivery Systems With Lubricious Coatings-Labeling Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability
Notices
D09002ee1bdb6c249
D09002ee1bdb6c2c9
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 or Agency) is announcing the availability of a final guidance entitled ``Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings- Labeling Considerations.'' This guidance addresses labeling considerations for devices containing lubricious coatings used in the vasculature. The purpose of this guidance is to provide recommendations for information to be included in the device labeling, as submitted in premarket applications (PMAs) or premarket notification submissions (510(k)s) for Class III and Class II devices, to enhance the consistency of information across these product areas as well as to promote the safe use of these devices in the clinical setting.
84 FR 54608
https://www.govinfo.gov/app/details/FR-2019-10-10/2019-22192
2019-22192
fr10oc19-63
4164-01-P
Docket No. FDA-2018-D-1788
https://www.govinfo.gov/app/details/FR-2019-10-10/2019-22192
https://www.govinfo.gov/content/pkg/FR-2019-10-10/html/2019-22192.htm
https://www.govinfo.gov/content/pkg/FR-2019-10-10/pdf/2019-22192.pdf
2 p.
54608
54609
84 FR 54608
Intravascular Catheters, Wires, and Delivery Systems With Lubricious Coatings-Labeling Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability; Federal Register Vol. 84, Issue
NOTICE
2019-22192
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2018-D-1788
4164-01-P
2019-22192
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings- Labeling Considerations.'' This guidance addresses labeling considerations for devices containing lubricious coatings used in the vasculature. The purpose of this guidance is to provide recommendations for information to be included in the device labeling, as submitted in premarket applications (PMAs) or premarket notification submissions (510(k)s) for Class III and Class II devices, to enhance the consistency of information across these product areas as well as to promote the safe use of these devices in the clinical setting.
The announcement of the guidance is published in the Federal Register on October 10, 2019.
Leigh Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2656, Silver Spring, MD 20993-0002, 301-796-5613.
Guidance:
Intravascular Catheters, Wires, and Delivery Systems with Lubricious CoatingsLabeling Considerations
,
CDRH-Guidance@fda.hhs.gov
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 197
Office of the Federal Register, National Archives and Records Administration
2019-10-10
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307 p.
Table of Contents:
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KF70.A2
https://www.govinfo.gov/app/details/FR-2019-10-10
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https://www.govinfo.gov/app/details/FR-2019-10-10
https://www.govinfo.gov/content/pkg/FR-2019-10-10/pdf/FR-2019-10-10.pdf
https://www.govinfo.gov/content/pkg/FR-2019-10-10/xml/FR-2019-10-10.xml
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FR-2019-10-10
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