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2018-11-06
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Metal Expandable Biliary Stents-Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Notices
D09002ee1bdb8b502
D09002ee1bdb8b553
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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Metal Expandable Biliary Stents--Premarket Notification (510(k)) Submissions.'' This draft guidance provides recommendations for information and testing that should be included in 510(k) submissions for metal expandable biliary stents and their associated delivery systems intended to provide luminal patency of malignant strictures in the biliary tree. This draft guidance is not final nor is it in effect at this time.
83 FR 33940
https://www.govinfo.gov/app/details/FR-2018-07-18/2018-15294
2018-15294
fr18jy18-44
4164-01-P
Docket No. FDA-2018-D-1771
https://www.govinfo.gov/app/details/FR-2018-07-18/2018-15294
https://www.govinfo.gov/content/pkg/FR-2018-07-18/html/2018-15294.htm
https://www.govinfo.gov/content/pkg/FR-2018-07-18/pdf/2018-15294.pdf
2 p.
33940
33941
83 FR 33940
Metal Expandable Biliary Stents-Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Federal Register Vol. 83, Issue
NOTICE
2018-15294
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2018-09-17
Docket No. FDA-2018-D-1771
4164-01-P
2018-15294
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Metal Expandable Biliary Stents--Premarket Notification (510(k)) Submissions.'' This draft guidance provides recommendations for information and testing that should be included in 510(k) submissions for metal expandable biliary stents and their associated delivery systems intended to provide luminal patency of malignant strictures in the biliary tree. This draft guidance is not final nor is it in effect at this time.
Submit either electronic or written comments on the draft guidance by September 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
April Marrone, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G218, Silver Spring, MD 20993-0002, 240-402-6510.
Guidance:
Metal Expandable Biliary StentsPremarket Notification (510(k)) Submissions
,
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. 83, no. 138
Office of the Federal Register, National Archives and Records Administration
2018-07-18
continuing
daily
deposited
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233 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2018-07-18
P0b002ee19da427c5
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr18jy18
https://www.govinfo.gov/app/details/FR-2018-07-18
https://www.govinfo.gov/content/pkg/FR-2018-07-18/pdf/FR-2018-07-18.pdf
https://www.govinfo.gov/content/pkg/FR-2018-07-18/xml/FR-2018-07-18.xml
fdlp
33795
34020
DGPO
2018-11-06
2023-04-28
FR-2018-07-18
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eng
FR
FR-2018-07-18
83
138