FDA Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document

标准简介

标准截图

标准文档说明

标准部分原文

Draft — Not for Implementation 1

1 Guidance for Industry

2 Coronary Drug-Eluting Stents — Companion Document 3 4 5 6 This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current 7 thinking on this topic.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 8 bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements 9 of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA 10 staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call 11 the appropriate number listed on the title page of this guidance. 12 13 14 15 16 INTRODUCTION 17 18 This guidance is intended to be used as a companion document to the guidance Coronary Drug 19 Eluting Stents — Nonclinical and Clinical Studies, which provides recommendations to sponsors 2

20 or applicants planning to develop, or to submit to FDA, a marketing application for a coronary 21 drug eluting stent (DES). This companion document provides additional and more detailed 22 guidance on some of the recommendations in the Coronary Drug Eluting Stents guidance, 23 including details on premarket approvals (PMAs), investigational device exemptions (IDEs), DRAFT

24 examples of various tables that may be submitted, and information on labeling a DES. 25 26 FDA's guidance documents, including this guidance, do not establish legally enforceable 27 responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should 28 be viewed only as recommendations, unless specific regulatory or statutory requirements are 29 cited. The use of the word should in Agency guidances means that something is suggested or 30 recommended, but not required. 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) submissions and applicant is used primarily in relation to premarket approval (PMA) submissions. 6255companion.doc

网盘链接

百度网盘：https://pan.baidu.com/s/1cj13QKFnbqy5meguQb_dCw
提取码：251k