FDA Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies

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Draft — Not for Implementation 1

1 Guidance for Industry 2 Coronary Drug-Eluting Stents —Nonclinical and Clinical Studies 3 4 5 6 This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current 7 thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind 8 FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the 9 applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff 10 responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the 11 appropriate number listed on the title page of this guidance. 12 13 14 15 I. INTRODUCTION 16 2

17 This guidance is intended to provide recommendations to sponsors or applicants planning to 18 develop, or to submit to FDA, a marketing application for a coronary drug eluting stent (DES). The 19 guidance discusses the data and clinical studies needed to support such an application. This guidance 20 does not discuss noncoronary DESs (e.g., peripheral drug-eluting, nonvascular biliary stents) or 21 stents that contain biological product components such as cell or gene therapy or therapeutic 22 biological products such as monoclonal antibodies. The guidance makes recommendations for stents 23 made from metallic stent substrates, but does not provide complete information for degradable stents DRAFT

24 or stents made from other material substrates (e.g., polymer or ceramics). 25 26 The associated companion document provides additional information that may be useful, including 27 suggested contents of investigational and premarket approval applications; various examples (e.g., 28 example of a DES clinical study summary, a commitment table, test article certification); 29 information on good animal husbandry, biocompatibility considerations, and issues related to U.S. 30 and OUS (outside the U.S.) studies; and labeling recommendations. The companion document is 31 intended to be used together with this guidance. 32 33 FDA's guidance documents, including this guidance, do not establish legally enforceable 34 responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be 35 viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The 1

This guidance has been prepared by a working group that included members of the Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation and Research (CDER), and Office of Combination Products (OCP) in the Office of the Commissioner at the Food and Drug Administration. 2

For purposes of this guidance, sponsor refers to any person who takes the responsibility for and initiates a clinical investigation; applicant refers to any person who submits an application, amendment, or supplement to obtain FDA approval of a new medical product or any other person who owns an approved application. Sponsor is used primarily in relation to investigational device exemption (IDE) applications and applicant is used primarily in relation to premarket approval (PMA) submissions. 3/26/2008

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