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GUIDANCE DOCUMENT

Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems Guidance for Industry and Food and Drug Administration Staff August 2015

Download the Final Guidance Document
Final
Docket Number:
FDA-2013-D-0920
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

FDA has developed this guidance to inform the coronary and peripheral stent industry about selected updates to FDA’s thinking regarding certain non-clinical testing for these devices. While FDA is in the process of making more substantial updates to the Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems guidance, we are issuing this guidance update on select sections in order to notify the industry in a timely manner of our revised recommendations.

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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-2013-D-0920.

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