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GUIDANCE DOCUMENT

Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies March 2008

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2008-D-0180
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health

This guidance is intended to provide recommendations to sponsors or applicants planning to develop, or to submit to FDA, a marketing application for a coronary drug eluting stent (DES). The guidance discusses the data and clinical studies needed to support such an application. This guidance does not discuss noncoronary DESs (e.g., peripheral drug-eluting, nonvascular biliary stents) or stents that contain biological product components such as cell or gene therapy or therapeutic biological products such as monoclonal antibodies. The guidance makes recommendations for stents made from metallic stent substrates, but does not provide complete information for degradable stents or stents made from other material substrates (e.g., polymer or ceramics).


Submit Comments

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-2008-D-0180.