FDA Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus Draft
标准简介
Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus Draft[附网盘链接]由FDA于不久前发布，适用于美国。标准截图
![Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus Draft[附网盘链接]](/img/202109141036064ybhj.jpg)
标准文档说明
标准文档类型为Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus Draft[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Draft – Not for Implementation
1 Feasibility and Early Feasibility 2 Clinical Studies for Certain Medical 3 Devices Intended to Therapeutically 4 Improve Glycemic Control in Patients 5 with Type 2 Diabetes Mellitus
6 Draft Guidance for Industry and
7 Food and Drug Administration Staff
8
9 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 10 Administration (FDA or we) on this topic. It does not establish any rights for any person and 11 is not binding on FDA or the public. You can use an alternative approach if it satisfies the 12 requirements of the applicable statutes and regulations. To discuss an alternative approach, 13 contact the FDA staff or Office responsible for this guidance as listed on the title page. 14 I. Introduction
15 This draft guidance document provides recommendations for feasibility and early feasibility 16 clinical studies for certain medical devices intended to therapeutically improve glycemic control 17 in patients with Type 2 Diabetes Mellitus (T2DM). These medical devices are intended to 18 therapeutically reduce glycated hemoglobin (HbA1c) in T2DM patients independent of 19 medication (e.g., insulin) delivery. 20
21 The contents of this document do not have the force and effect of law and are not meant to bind the 22 public in any way, unless specifically incorporated into a contract. This document is intended only to 23 provide clarity to the public regarding existing requirements under the law. FDA guidance 24 documents, including this guidance, should be viewed only as recommendations, unless specific 25 regulatory or statutory requirements are cited. The use of the word should in Agency guidance 26 means that something is suggested or recommended, but not required. 27
28 II. Background
29 Type 2 Diabetes Mellitus (T2DM) is a metabolic disorder that is characterized by high blood 30 sugar levels, insulin resistance, and relative lack of insulin. In 2020, it is estimated that 10.5% of
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