美国FDA《联邦规章典集》（CFR）第21篇目录翻译

美国FDA《联邦规章典集》（CFR）第21篇目录翻译 美国《联邦规章典集》(CFR)第21篇“食品与药品”总目 概述:美国《联邦规章典集》(Code of Federal Regulations，CFR)第21篇“食品与药品”(Title 21―Food and Drugs)共有9卷(Volume)、3章(Chapter)、1499部(Parts)。其中:第1―8卷第1章第1―1299部，为健康与人类服务部食品与药品管理局(Food and Drug Administration，Department of Health and Human Services)的规章;第9卷第2章第1300―1399部，为司法部毒品强制执行局(Drug Enforcement Administration，Department of Justice)的规章;第9卷第3章第1400―1499部，为毒品控制政策办公室(Office of National Drug Control Policy)的规章。 第21篇“食品与药品”(Title 21―Food and Drugs)的概况 卷(Volume) 章(Chapter) 部(Parts) 规制机关(Regulatory Entity) 1 1-99 健康与人类服务部食品与药品管理局(FOOD AND DRUG ADMINISTRATION, 2 100-169 DEPARTMENT OF HEALTH AND HUMAN 3 170-199 SERVICES) 4 200-299 ? 5 300-499 6 500-599 7 600-799 8 800-1299 9 司法部毒品强制执行局(Drug Enforcement ? 1300-1399 Administration，Department of Justice) 毒品控制政策办公室(Office of National Drug ? 1400-1499 Control Policy) 第21篇“食品与药品”(Title 21―Food and Drugs)的章、部目录 部(Part) 中译文 原英文 第?章―健康与人类服务部食品与药品管理局(CHAPTER ?―FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES) 第A分章―总则(SUBCHAPTER A―GENERAL) 1 GENERAL ENFORCEMENT REGULATIONS 一般强制执行规章 GENERAL ADMINISTRATIVE RULINGS AND 一般行政规则与决定 2 DECISIONS 3 PRODUCT JURISDICTION 产品管辖权 5 ORGANIZATION 组织 7 ENFORCEMENT POLICY 强制执行政策 ADMINISTRATIVE PRACTICES AND 行政规范与程序 10 PROCEDURES ELECTRONIC RECORDS; ELECTRONIC 电子化记录;电子化签名 11 SIGNATURES 12 FORMAL EVIDENTIARY PUBLIC HEARING 正式证据的公众听证 PUBLIC HEARING BEFORE A PUBLIC BOARD 在公众质询委员会前的公众听 13 OF INQUIRY 证 PUBLIC HEARING BEFORE A PUBLIC 在公众咨询委员会前的公众听 14 ADVISORY COMMITTEE 证 PUBLIC HEARING BEFORE THE 在FDA局长前的公众听证 15 COMMISSIONER REGULATORY HEARING BEFORE THE FOOD 在FDA前的规制性听证 16 AND DRUG ADMINISTRATION 17 CIVIL MONEY PENALTIES HEARINGS 行政罚款听证 STANDARDS OF CONDUCT AND CONFLICTS 行为标准与利益冲突 19 OF INTEREST 20 PUBLIC INFORMATION 公共信息 21 PROTECTION OF PRIVACY 隐私保护 25 ENVIRONMENTAL IMPACT CONSIDERATIONS 环境影响考虑 MUTUAL RECOGNITION OF 药品良好制造规范报告、医疗器 PHARMACEUTICAL GOOD MANUFACTURING 械质量体系核查报告以及某些 PRACTICE REPORTS, MEDICAL DEVICE 医疗器械产品评价报告的互认: 26 QUALITY SYSTEM AUDIT REPORTS, AND 美国与欧共体 CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY 50 PROTECTION OF HUMAN SUBJECTS 人类受试者的保护 FINANCIAL DISCLOSURE BY CLINICAL 临床试验者的财务公开 54 INVESTIGATORS 56 INSTITUTIONAL REVIEW BOARDS 机构审查委员会 GOOD LABORATORY PRACTICE FOR 对非临床实验室研究的良好实 58 NONCLINICAL LABORATORY STUDIES 验室规范 60 PATENT TERM RESTORATION 专利期恢复 70 COLOR ADDITIVES 色素添加剂 71 COLOR ADDITIVE PETITIONS 色素添加剂申请 LISTING OF COLOR ADDITIVES EXEMPT 免除认证的色素添加剂的列表 73 FROM CERTIFICATION LISTING OF COLOR ADDITIVES SUBJECT TO 适用认证的色素添加剂的列表 74 CERTIFICATION 80 COLOR ADDITIVE CERTIFICATION 色素添加剂认证 GENERAL SPECIFICATIONS AND GENERAL 用于食品、药品和化妆品的临时 RESTRICTIONS FOR PROVISIONAL COLOR 性色素添加剂的一般规范和一 81 ADDITIVES FOR USE IN FOODS, DRUGS, AND 般限制 COSMETICS LISTING OF CERTIFIED PROVISIONALLY 经认证的临时性列表的色素和 82 LISTED COLORS AND SPECIFICATIONS 规范的列表 83-98 [Reserved] [预留的] DISSEMINATION OF INFORMATION ON 已上市的药品、生物制品和器械99 UNAPPROVED/NEW USES FOR MARKETED 的未经批准的/新的用途的信息 DRUGS, BIOLOGICS, AND DEVICES 的发布 第B分章―用于人类消费的食品(SUBCHAPTER B―FOOD FOR HUMAN CONSUMPTION) 100 GENERAL 总则 101 FOOD LABELING 食品标识 COMMON OR USUAL NAME FOR 非标准化食品的普通的或者通102 NONSTANDARDIZED FOODS 常的名称 NUTRITIONAL QUALITY GUIDELINES FOR 食品的营养质量指南 104 FOODS 105 FOODS FOR SPECIAL DIETARY USE 特殊膳食用途的食品 INFANT FORMULA QUALITY CONTROL 婴儿配方母乳替代食品质量控106 PROCEDURES 制程序 107 INFANT FORMULA 婴儿配方母乳替代食品 108 EMERGENCY PERMIT CONTROL 紧急许可控制 UNAVOIDABLE CONTAMINANTS IN FOOD 在人类食品与食品-包装材料中109 FOR HUMAN CONSUMPTION AND 的不可避免的污染物 FOOD-PACKAGING MATERIAL CURRENT GOOD MANUFACTURING 在制造、包装或者保存人类食品110 PRACTICE IN MANUFACTURING, PACKING, OR 中的现行良好制造规范 HOLDING HUMAN FOOD THERMALLY PROCESSED LOW-ACID FOODS 装在密封容器中的热加工低酸113 PACKAGED IN HERMETICALLY SEALED 食品 CONTAINERS 114 ACIDIFIED FOODS 酸化食品 115 SHELL EGGS 带壳蛋 DIETARY SUPPLEMENTS THAT PRESENT A 存在显著或者不合理风险的膳119 SIGNIFICANT OR UNREASONABLE RISK 食补充剂 HAZARD ANALYSIS AND CRITICAL CONTROL 危害与关键控制点120 POINT (HACCP) SYSTEMS (HACCP)体系 123 FISH AND FISHERY PRODUCTS 鱼与渔业产品 PROCESSING AND BOTTLING OF BOTTLED 饮用水加工与装瓶 129 DRINKING WATER 130 FOOD STANDARDS: GENERAL 食品标准:总则 131 MILK AND CREAM 乳与奶油 133 CHEESES AND RELATED CHEESE PRODUCTS 乳酪与相关乳酪产品 135 FROZEN DESSERTS 冷冻点心 136 BAKERY PRODUCTS 烘焙产品 137 CEREAL FLOURS AND RELATED PRODUCTS 谷物粉与相关产品 139 MACARONI AND NOODLE PRODUCTS 通心粉与面条产品 145 CANNED FRUITS 罐装水果 146 CANNED FRUIT JUICES 罐装水果汁 FRUIT BUTTERS, JELLIES, PRESERVES, AND 水果黄油、果冻、防腐剂以及相 150 RELATED PRODUCTS 关产品 152 FRUIT PIES 水果馅饼 155 CANNED VEGETABLES 罐装蔬菜 156 VEGETABLE JUICES 蔬菜汁 158 FROZEN VEGETABLES 冷冻蔬菜 160 EGGS AND EGG PRODUCTS 蛋与蛋制品 161 FISH AND SHELLFISH 鱼与有壳的水生动物 163 CACAO PRODUCTS 可可制品 164 TREE NUT AND PEANUT PRODUCTS 树坚果与花生制品 165 BEVERAGES 饮料 166 MARGARINE 人造黄油 168 SWEETENERS AND TABLE SIRUPS 增甜剂与餐桌糖浆 169 FOOD DRESSINGS AND FLAVORINGS 食品敷料与调味料 170 FOOD ADDITIVES 食品添加剂 171 FOOD ADDITIVE PETITIONS 食品添加剂申请 FOOD ADDITIVES PERMITTED FOR DIRECT 允许直接加入用于人类消费食172 ADDITION TO FOOD FOR HUMAN 品的食品添加剂 CONSUMPTION SECONDARY DIRECT FOOD ADDITIVES 在用于人类消费的食品中允许173 PERMITTED IN FOOD FOR HUMAN 的次直接的食品添加剂 CONSUMPTION 174 INDIRECT FOOD ADDITIVES: GENERAL 间接食品添加剂:总则 INDIRECT FOOD ADDITIVES: ADHESIVES AND 间接食品添加剂:胶粘剂与涂层175 COMPONENTS OF COATINGS 的组分 INDIRECT FOOD ADDITIVES: PAPER AND 间接食品添加剂:纸与纸板组分 176 PAPERBOARD COMPONENTS 177 INDIRECT FOOD ADDITIVES: POLYMERS 间接食品添加剂:聚合体 INDIRECT FOOD ADDITIVES: ADJUVANTS, 间接食品添加剂:辅剂、生产助178 PRODUCTION AIDS, AND SANITIZERS 剂和消毒剂 IRRADIATION IN THE PRODUCTION, 在食品生产、加工和处理中的辐179 PROCESSING AND HANDLING OF FOOD 照 FOOD ADDITIVES PERMITTED IN FOOD OR IN 在额外试验期间临时在食品或180 CONTACT WITH FOOD ON AN INTERIM BASIS 者在与食品接触中被允许的食 PENDING ADDITIONAL STUDY 品添加剂 181 PRIOR-SANCTIONED FOOD INGREDIENTS 先前核准的食品配料 SUBSTANCES GENERALLY RECOGNIZED AS 一般认为安全的物质 182 SAFE DIRECT FOOD SUBSTANCES AFFIRMED AS 被确认为一般认为安全的直接184 GENERALLY RECOGNIZED AS SAFE 食品物质 186 INDIRECT FOOD SUBSTANCES AFFIRMED AS 被确认为一般认为安全的间接 GENERALLY RECOGNIZED AS SAFE 食品物质 SUBSTANCES PROHIBITED FROM USE IN 禁止用于人类食品的物质 189 HUMAN FOOD 190 DIETARY SUPPLEMENTS 膳食补充剂 191-199 [Reserved] [预留的] 第C分章―药品:总则(SUBCHAPTER C―DRUGS: GENERAL) 200 GENERAL 总则 201 LABELING 标识 202 PRESCRIPTION DRUG ADVERTISING 处方药广告 203 PRESCRIPTION DRUG MARKETING 处方药销售 GUIDELINES FOR STATE LICENSING OF 对批发处方药销售商颁发州执 205 WHOLESALE PRESCRIPTION DRUG 照的指南 DISTRIBUTORS IMPRINTING OF SOLID ORAL DOSAGE FORM 人用固体口服剂型药品的印码 206 DRUG PRODUCTS FOR HUMAN USE REGISTRATION OF PRODUCERS OF DRUGS 药品生产者的登记与商业销售 207 AND LISTING OF DRUGS IN COMMERCIAL 的药品的列表 DISTRIBUTION MEDICATION GUIDES FOR PRESCRIPTION 处方药的药物治疗指导 208 DRUG PRODUCTS CURRENT GOOD MANUFACTURING 制造、加工、包装或者保存药品 210 PRACTICE IN MANUFACTURING, PROCESSING, 的现行良好制造规范;总则 PACKING, OR HOLDING OF DRUGS; GENERAL CURRENT GOOD MANUFACTURING 对完成的药品的现行良好制造 211 PRACTICE FOR FINISHED 规范 PHARMACEUTICALS 216 PHARMACY COMPOUNDING 药房配药 225 CURRENT GOOD MANUFACTURING 对含药饲料的现行良好制造规 PRACTICE FOR MEDICATED FEEDS 范 CURRENT GOOD MANUFACTURING 对A型含药物品的现行良好制 226 PRACTICE FOR TYPE A MEDICATED 造规范 ARTICLES SPECIAL REQUIREMENTS FOR SPECIFIC 对特殊人用药品的特殊要求 250 HUMAN DRUGS 290 CONTROLLED DRUGS 管制的药品 DRUGS; OFFICIAL NAMES AND ESTABLISHED 药品;正式名称与已确定的名称 299 NAMES 第D分章―人用药品(SUBCHAPTER D―DRUGS FOR HUMAN USE) 300 GENERAL 总则 310 NEW DRUGS 新药 312 INVESTIGATIONAL NEW DRUG APPLICATION 试验用新药申请 APPLICATIONS FOR FDA APPROVAL TO 为FDA批准上市新药的申请 314 MARKET A NEW DRUG 315 DIAGNOSTIC RADIOPHARMACEUTICALS 诊断用放射性药品 316 ORPHAN DRUGS 罕见病药 BIOAVAILABILITY AND BIOEQUIVALENCE 生物利用度与生物等效性要求 320 REQUIREMENTS OVER-THE-COUNTER DRUG PRODUCTS 含有酒精的预期用于口部摄入 328 INTENDED FOR ORAL INGESTION THAT 的非处方药品 CONTAIN ALCOHOL OVER-THE-COUNTER (OTC) HUMAN DRUGS 一般认为安全与有效以及不错 WHICH ARE GENERALLY RECOGNIZED AS 误标识的非处方人用药品 330 SAFE AND EFFECTIVE AND NOT MISBRANDED ANTACID PRODUCTS FOR 用于非处方的人类使用的抗酸 331 OVER-THE-COUNTER (OTC) HUMAN USE 产品 ANTIFLATULENT PRODUCTS FOR 用于非处方的人类使用的抗胃332 OVER-THE-COUNTER HUMAN USE 肠气胀产品 TOPICAL ANTIMICROBIAL DRUG PRODUCTS 用于非处方的人类使用的局部333 FOR OVER-THE-COUNTER HUMAN USE 抗菌药品 ANTIDIARRHEAL DRUG PRODUCTS FOR 用于非处方的人类使用的止泻335 OVER-THE-COUNTER HUMAN USE 药品 ANTIEMETIC DRUG PRODUCTS FOR 用于非处方的人类使用的止吐336 OVER-THE-COUNTER HUMAN USE 药品 NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR 用于非处方的人类使用的帮助338 OVER-THE-COUNTER HUMAN USE 夜间睡眠的药品 STIMULANT DRUG PRODUCTS FOR 用于非处方的人类使用的兴奋340 OVER-THE-COUNTER HUMAN USE 药品 COLD, COUGH, ALLERGY, BRONCHODILATOR, 用于非处方的人类使用的感冒、341 AND ANTIASTHMATIC DRUG PRODUCTS FOR 咳嗽、过敏症药、支气管扩张以 OVER-THE-COUNTER HUMAN USE 及平喘药品 INTERNAL ANALGESIC, ANTIPYRETIC, AND 用于非处方的人类使用的内服343 ANTIRHEUMATIC DRUG PRODUCTS FOR 的止痛、退热以及抗风湿药品 OVER-THE-COUNTER HUMAN USE TOPICAL OTIC DRUG PRODUCTS FOR 用于非处方的人类使用的局部344 OVER-THE-COUNTER HUMAN USE 的耳部药品 ANORECTAL DRUG PRODUCTS FOR 用于非处方的人类使用的肛肠346 OVER-THE-COUNTER HUMAN USE 药品 SKIN PROTECTANT DRUG PRODUCTS FOR 用于非处方的人类使用的皮肤347 OVER-THE-COUNTER HUMAN USE 保护药品 EXTERNAL ANALGESIC DRUG PRODUCTS 用于非处方的人类使用的外部348 FOR OVER-THE-COUNTER HUMAN USE 的止痛药品 OPHTHALMIC DRUG PRODUCTS FOR 用于非处方的人类使用的眼科349 OVER-THE-COUNTER HUMAN USE 药品 ANTIPERSPIRANT DRUG PRODUCTS FOR 用于非处方的人类使用的止汗 350 OVER-THE-COUNTER HUMAN USE 药品 SUNSCREEN DRUG PRODUCTS FOR 用于非处方的人类使用的遮光 352 OVER-THE-COUNTER HUMAN USE [STAYED 药品 INDEFINITELY] ANTICARIES DRUG PRODUCTS FOR 用于非处方的人类使用的防龋 355 OVER-THE-COUNTER HUMAN USE 药品 MISCELLANEOUS INTERNAL DRUG 用于非处方的人类使用的其他 357 PRODUCTS FOR OVER-THE-COUNTER 内服药品 HUMAN USE MISCELLANEOUS EXTERNAL DRUG 用于非处方的人类使用的其他 358 PRODUCTS FOR OVER-THE-COUNTER 外用药品 HUMAN USE PRESCRIPTION DRUGS FOR HUMAN USE 一般认为安全与有效以及不错 GENERALLY RECOGNIZED AS SAFE AND 误标识的处方人用药品:用于研 361 EFFECTIVE AND NOT MISBRANDED: DRUGS 究的药品 USED IN RESEARCH INTERPRETATIVE STATEMENTS RE 在用于非处方销售的药品与器 369 WARNINGS ON DRUGS AND DEVICES FOR 械上关于警告的解释性声明 OVER-THE-COUNTER SALE 370-499 [Reserved] [预留的] 第E分章―动物药品、饮料和相关产品(SUBCHAPTER E―ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS) 500 GENERAL 总则 501 ANIMAL FOOD LABELING 动物食品标识 COMMON OR USUAL NAMES FOR 非标准化的动物食品的普通的 502 NONSTANDARDIZED ANIMAL FOODS 或通常的名称 509 UNAVOIDABLE CONTAMINANTS IN ANIMAL 在动物食品与食品-包装材料中 FOOD AND FOOD-PACKAGING MATERIAL 的不可避免的污染物 510 NEW ANIMAL DRUGS 新动物药 NEW ANIMAL DRUGS FOR INVESTIGATIONAL 作为试验用途的新动物药 511 USE 514 NEW ANIMAL DRUG APPLICATIONS 新动物药申请 515 MEDICATED FEED MILL LICENSE 含药饲料厂执照 520 ORAL DOSAGE FORM NEW ANIMAL DRUGS 口服剂型的新动物药 IMPLANTATION OR INJECTABLE DOSAGE 植入或者注射剂型的新动物药 522 FORM NEW ANIMAL DRUGS OPHTHALMIC AND TOPICAL DOSAGE FORM 眼科和局部剂型的新动物药 524 NEW ANIMAL DRUGS 526 INTRAMAMMARY DOSAGE FORMS 乳房内的剂型 CERTAIN OTHER DOSAGE FORM NEW 某些其他剂型的新动物药 529 ANIMAL DRUGS 530 EXTRALABEL DRUG USE IN ANIMALS 在动物中的特别标签药品使用 TOLERANCES FOR RESIDUES OF NEW 在食品中新动物药残留的容许556 ANIMAL DRUGS IN FOOD 量 NEW ANIMAL DRUGS FOR USE IN ANIMAL 用于动物饲料的新动物药 558 FEEDS 564 [Reserved] [预留的] 570 FOOD ADDITIVES 食品添加剂 571 FOOD ADDITIVE PETITIONS 食品添加剂申请 FOOD ADDITIVES PERMITTED IN FEED AND 在动物饲料与饮用水中允许的573 DRINKING WATER OF ANIMALS 食品添加剂 IRRADIATION IN THE PRODUCTION, 在动物饲料和宠物食品的生产、579 PROCESSING, AND HANDLING OF ANIMAL 加工和处理中的辐照 FEED AND PET FOOD 582 SUBSTANCES GENERALLY RECOGNIZED AS 一般认为安全的物质 SAFE FOOD SUBSTANCES AFFIRMED AS 在动物饲料与饮用水中被确认 584 GENERALLY RECOGNIZED AS SAFE IN FEED 为一般认为安全的食品物质 AND DRINKING WATER OF ANIMALS SUBSTANCES PROHIBITED FROM USE IN 禁止用于动物食品或者饲料的 589 ANIMAL FOOD OR FEED 物质 590-599 [Reserved] [预留的] 第F分章―生物制品(SUBCHAPTER F―BIOLOGICS) 600 BIOLOGICAL PRODUCTS: GENERAL 生物制品:总则 601 LICENSING 颁发执照 CURRENT GOOD MANUFACTURING 对血液与血液组分的现行良好 606 PRACTICE FOR BLOOD AND BLOOD 制造规范 COMPONENTS ESTABLISHMENT REGISTRATION AND 对人类血液与血液制品的制造 607 PRODUCT LISTING FOR MANUFACTURERS OF 者的机构登记与产品列表 HUMAN BLOOD AND BLOOD PRODUCTS GENERAL BIOLOGICAL PRODUCTS 普通生物制品标准 610 STANDARDS GENERAL REQUIREMENTS FOR BLOOD, 对血液、血液组分和血液衍生物 630 BLOOD COMPONENTS, AND BLOOD 的一般要求 DERIVATIVES ADDITIONAL STANDARDS FOR HUMAN 对人类血液和血液制品的附加 640 BLOOD AND BLOOD PRODUCTS 标准 ADDITIONAL STANDARDS FOR DIAGNOSTIC 对用于实验室检测的诊断物质 660 SUBSTANCES FOR LABORATORY TESTS 的附加标准 ADDITIONAL STANDARDS FOR 对其他产品的附加标准 680 MISCELLANEOUS PRODUCTS 第G分章―化妆品(SUBCHAPTER G―COSMETICS) 700 GENERAL 总则 701 COSMETIC LABELING 化妆品标识 VOLUNTARY REGISTRATION OF COSMETIC 化妆品机构的自愿登记 710 PRODUCT ESTABLISHMENTS VOLUNTARY FILING OF COSMETIC PRODUCT 化妆品配料构成声明的自愿存 720 INGREDIENT COMPOSITION STATEMENTS 档 COSMETIC PRODUCT WARNING 化妆品警告声明 740 STATEMENTS 741-799 [Reserved] [预留的] 第H分章―医疗器械(SUBCHAPTER H―MEDICAL DEVICES) 800 GENERAL 总则 801 LABELING 标识 803 MEDICAL DEVICE REPORTING 医疗器械报告 MEDICAL DEVICES; REPORTS OF 医疗器械;改正与移动的报告 806 CORRECTIONS AND REMOVALS ESTABLISHMENT REGISTRATION AND 对器械的制造者与首次进口者 807 DEVICE LISTING FOR MANUFACTURERS AND 的机构登记与器械列表 INITIAL IMPORTERS OF DEVICES EXEMPTIONS FROM FEDERAL PREEMPTION 对州和地方医疗器械要求的联 808 OF STATE AND LOCAL MEDICAL DEVICE 邦优先权的豁免 REQUIREMENTS IN VITRO DIAGNOSTIC PRODUCTS FOR 人用体外诊断产品 809 HUMAN USE 810 MEDICAL DEVICE RECALL AUTHORITY 医疗器械召回权 812 INVESTIGATIONAL DEVICE EXEMPTIONS 试验用器械豁免 813 [Reserved] [预留的] PREMARKET APPROVAL OF MEDICAL 医疗器械的上市前批准 814 DEVICES 820 QUALITY SYSTEM REGULATION 质量体系规章 MEDICAL DEVICE TRACKING 医疗器械跟踪要求 821 REQUIREMENTS 822 POSTMARKET SURVEILLANCE 上市后监视 MEDICAL DEVICE CLASSIFICATION 医疗器械分类程序 860 PROCEDURES PROCEDURES FOR PERFORMANCE 性能标准制定程序 861 STANDARDS DEVELOPMENT CLINICAL CHEMISTRY AND CLINICAL 临床化学与临床毒理学器械 862 TOXICOLOGY DEVICES 864 HEMATOLOGY AND PATHOLOGY DEVICES 血液学与病理学器械 IMMUNOLOGY AND MICROBIOLOGY 免疫学与微生物学器械 866 DEVICES 868 ANESTHESIOLOGY DEVICES 麻醉学器械 870 CARDIOVASCULAR DEVICES 心血管器械 872 DENTAL DEVICES 牙科器械 874 EAR, NOSE, AND THROAT DEVICES 耳、鼻和咽器械 876 GASTROENTEROLOGY-UROLOGY DEVICES 胃肠病学-泌尿学器械 878 GENERAL AND PLASTIC SURGERY DEVICES 普通与整形外科器械 GENERAL HOSPITAL AND PERSONAL USE 普通医院与个人使用器械 880 DEVICES 882 NEUROLOGICAL DEVICES 神经学器械 OBSTETRICAL AND GYNECOLOGICAL 产科与妇科学器械 884 DEVICES 886 OPHTHALMIC DEVICES 眼科器械 888 ORTHOPEDIC DEVICES 矫形外科器械 890 PHYSICAL MEDICINE DEVICES 内科学器械 892 RADIOLOGY DEVICES 放射学器械 895 BANNED DEVICES 禁止的器械 PERFORMANCE STANDARD FOR ELECTRODE 电极铅线与患者电缆的性能标 898 LEAD WIRES AND PATIENT CABLES 准 第I分章―乳房造影质量标准法(SUBCHAPTER I―MAMMOGRAPHY QUALITY STANDARDS ACT) 900 MAMMOGRAPHY 乳房造影法 第J分章―放射学的健康(SUBCHAPTER J―RADIOLOGICAL HEALTH) 1000 GENERAL 总则 1002 RECORDS AND REPORTS 记录与报告 NOTIFICATION OF DEFECTS OR FAILURE TO 缺陷与未能守法的通报 1003 COMPLY REPURCHASE, REPAIRS, OR REPLACEMENT 电子产品的回购、修理或者置换 1004 OF ELECTRONIC PRODUCTS 1005 IMPORTATION OF ELECTRONIC PRODUCTS 电子产品的进口 PERFORMANCE STANDARDS FOR 电子产品的性能标准:总则 1010 ELECTRONIC PRODUCTS: GENERAL PERFORMANCE STANDARDS FOR IONIZING 电离辐射发生产品的性能标准 1020 RADIATION EMITTING PRODUCTS PERFORMANCE STANDARDS FOR 微波与射电频率发生产品的性 1030 MICROWAVE AND RADIO FREQUENCY 能标准 EMITTING PRODUCTS PERFORMANCE STANDARDS FOR 发光产品的性能标准 1040 LIGHT-EMITTING PRODUCTS PERFORMANCE STANDARDS FOR SONIC, 声波、次声波和超声波发生产品 1050 INFRASONIC, AND ULTRASONIC 的性能标准 RADIATION-EMITTING PRODUCTS 第K分章―[预留的](SUBCHAPTER K―[RESERVED]) 第L分章―根据由食品与药品管理局行政执行的某些其他法的规章(SUBCHAPTER L―REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION) REGULATIONS UNDER THE FEDERAL IMPORT 根据《联邦进口乳法》的规章 1210 MILK ACT REGULATIONS UNDER THE FEDERAL 根据《联邦腐蚀性毒物法》的规 1230 CAUSTIC POISON ACT 章 1240 CONTROL OF COMMUNICABLE DISEASES 传染病的控制 1250 INTERSTATE CONVEYANCE SANITATION 州际运输卫生 1251-1269 [Reserved] [预留的] HUMAN TISSUE INTENDED FOR 预期用于移植的人体组织 1270 TRANSPLANTATION HUMAN CELLS, TISSUES, AND CELLULAR 人体细胞、组织以及细胞的和基 1271 AND TISSUE-BASED PRODUCTS 于组织的产品 1272-1299 [Reserved] [预留的] 第?章―司法部毒品强制执行局(CHAPTER ?―DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE) 1300 DEFINITIONS 定义 REGISTRATION OF MANUFACTURERS, 管制物质的制造者、分销者和调 1301 DISTRIBUTORS, AND DISPENSERS OF 剂者的登记 CONTROLLED SUBSTANCES LABELING AND PACKAGING REQUIREMENTS 对管制物质的标识与包装要求 1302 FOR CONTROLLED SUBSTANCES 1303 QUOTAS 定额 1304 RECORDS AND REPORTS OF REGISTRANTS 登记者的记录与报告 1305 ORDER FORMS 令的格式 1306 PRESCRIPTIONS 处方 1307 MISCELLANEOUS 杂项 1308 SCHEDULES OF CONTROLLED SUBSTANCES 管制物质的表 REGISTRATION OF MANUFACTURERS, 表I化学品的制造者、分销者、 1309 DISTRIBUTORS, IMPORTERS AND EXPORTERS 进口者和出口者的登记 OF LIST I CHEMICALS RECORDS AND REPORTS OF LISTED 列入表的化学品和某些机器的 1310 CHEMICALS AND CERTAIN MACHINES 记录与报告 1311 [Reserved] [预留的] IMPORTATION AND EXPORTATION OF 管制物质的进口与出口 1312 CONTROLLED SUBSTANCES IMPORTATION AND EXPORTATION OF 前体与必要化学品的进口与出 1313 PRECURSORS AND ESSENTIAL CHEMICALS 口 1314-1315 [Reserved] [预留的] ADMINISTRATIVE FUNCTIONS, PRACTICES, 行政职能、规范和程序 1316 AND PROCEDURES 第?章―毒品控制政策办公室(CHAPTER ?―Office of National Drug Control Policy) 1400 [Reserved] [预留的] 1401 PUBLIC AVAILABILITY OF INFORMATION 信息的公众可及性 1402 MANDATORY DECLASSIFICATION REVIEW 强制性解密审查 UNIFORM ADMINISTRATIVE REQUIREMENTS 对给予州和地方政府资金和合 FOR GRANTS AND COOPERATIVE 作的统一行政要求 1403 AGREEMENTS TO STATE AND LOCAL GOVERNMENTS GOVERNMENTWIDE DEBARMENT AND 政府范围的排除与暂停(非获 1404 SUSPENSION (NONPROCUREMENT) 得) GOVERNMENTWIDE REQUIREMENTS FOR 对无毒品工作场所的政府范围 1405 DRUG-FREE WORKPLACE (FINANCIAL 的要求(财政援助) ASSISTANCE) 1406-1499 [Reserved] [预留的]