您可以查阅FDA官方网站上的相关资料,例如《食品法典》(Food Code)、《药物法典》(Drug Code)、医疗器械分类数据库(Medical Device Classification Database)等,来了解产品的分类依据。 产品功能和用途:考虑产品的主要功能和用途是确定其分类的重要因素。例如,如果产品是一种食品补充剂,那么它可能属于食品类别;如果产品是...
U.S. Code: Table Of Contents | U.S. Code | US Law | LII / Legal Information Institute (cornell.edu) 美国联邦食品、药品和化妆品法案(FD & C Act)入口 https://www.law.cornell.edu/uscode/text/21/chapter-9 FD&C Act Chapter V:药品和器械入口 https://www.law.cornell.edu/uscode/text/...
Device Description In your 510(k) submission, you should identify the regulation, the product code(s), and a legally marketed predicate device. We recommend that you include a table that outlines the similarities and differences between the predicate device and your device. You should include the...
点击Patent and Exclusivity Info for this product:?Click Here? 大功告成: /scripts/cder/ob/docs/patexcl.cfm?Appl_No=020702Product_No=001table1=Rx FDA宝库之一? List of Orphan Designations and Approvals? Drug Lists--A cumulative list of designated orphan products, updated monthly, includes ...
Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) June 2008 Electronic Submissions Revision 1 TABLE OF CONTENTS I. INTRODUCTION 1 II. BACKGROUND 1 A. When Did the Use of SPL ...
确保LBSTRESC 和 LBTEST 中的受控术语扩展不包含字节值 160-191 [译注:扩展字节的编码见ASCII Code - The extended ASCII table] ,因为该范围内的某些字符映射可能会干扰代理流程。3.3.6 Variable and Dataset Names 变量和数据集名称Variable names should contain only uppercase letters, numbers, and must start...
168 增甜剂与餐桌糖浆SWEETENERS AND TABLE SIRUPS 169 食品敷料与调味料FOOD DRESSINGS AND FLAVORINGS 170 食品添加剂FOOD ADDITIVES 171 食品添加剂申请FOOD ADDITIVE PETITIONS 172 允许直接加入用于人类消费食品的食品添加剂FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION 173 在用于人类...
CHANGE CONTROL TABLE...10 PURPOSE This MAPP describes the new drug application (NDA) classification code assigned by the Center for Drug Evaluation and Research (CDER) to an NDA based on characteristics of the product in the application. This code was previously referred to as “Chemistry Classif...
DIRECTION OF GMP (GOOD MANUFACTURING PRACTICE )OF RAW MATERIALS BY FDA 美国 FDA 原料药生产质量管理规范( 中英文) Table of Contents 目录 1. INTRODUCTION 简介 Objective 目的 Regulatory Applicability 法规的适用性 Scope 范围 2. QUALITY MANAGEMENT .质量管理 Principles 总则 Responsibilities of the Quality ...
FDA认证（FDA certification）是指由美国食品药品监督管理局（Food and Drug Administration）所颁发的认证...