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GUIDANCE DOCUMENT

Metal Expandable Biliary Stents - Premarket Notification (510(k)) Submissions Guidance for Industry and Food and Drug Administration Staff July 2019

Download the Final Guidance Document
Final
Docket Number:
FDA-2018-D-1771
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance document provides recommendations for 510(k) submissions for metal expandable biliary stents and their associated delivery systems. These devices are intended to provide luminal patency of the biliary tree for palliation of malignant strictures. FDA updated this guidance to reflect current review practices.

For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, please refer to FDA guidance titled "Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices."

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2018-D-1771.

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