美国FDA《联邦规章典集》(CFR)第21篇目录中文版
美国FDA《联邦规章典集》（CFR）第21篇目录中文版
发布时间：2010-5-11 13:44:12 发布方：奥咨达医疗器械咨询
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”（Tit le 21―Food and Drugs）的概况
卷（Volume）章（Chapter）部（Parts）规制机关（Regulatory Entity）
1 Ⅰ1-99 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）
2 100-169
3 170-199
4 200-299
5 300-499
6 500-599
7 600-799
8 800-1299
9 Ⅱ1300-1399 司法部毒品强制执行局（Drug Enforcement Administration，Department of Justice）
Ⅲ1400-1499 毒品控制政策办公室（Office of National Drug 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Ⅰ章―健康与人类服务部食品与药品管理局（CHAPTER Ⅰ―FOOD AND DRUG ADMINIST RATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES）
第A分章―总则（SUBCHAPTER A―GENERAL）
1 一般强制执行规章GENERAL ENFORCEMENT REGULATIONS
2 一般行政规则与决定GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
3 产品管辖权PRODUCT JURISDICTION
5 组织ORGANIZATION
7 强制执行政策ENFORCEMENT POLICY
10 行政规范与程序ADMINISTRATIVE PRACTICES AND PROCEDURES
11 电子化记录；电子化签名ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
12 正式证据的公众听证FORMAL EVIDENTIARY PUBLIC HEARING
13 在公众质询委员会前的公众听证PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY
14 在公众咨询委员会前的公众听证PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
15 在FDA局长前的公众听证PUBLIC HEARING BEFORE THE COMMISSIONER
16 在FDA前的规制性听证REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
17 行政罚款听证CIVIL MONEY PENALTIES HEARINGS
19 行为标准与利益冲突STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST
20 公共信息PUBLIC INFORMATION
21 隐私保护PROTECTION OF PRIVACY
25 环境影响考虑ENVIRONMENTAL IMPACT CONSIDERATIONS
26 药品良好制造规范报告、医疗器械质量体系核查报告以及某些医疗器械产品评价报告的互认：美国与欧共体MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY
50 人类受试者的保护PROTECTION OF HUMAN SUBJECTS
54 临床试验者的财务公开FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
56 机构审查委员会INSTITUTIONAL REVIEW BOARDS
58 对非临床实验室研究的良好实验室规范GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
60 专利期恢复PATENT TERM RESTORATION
70 色素添加剂COLOR ADDITIVES
71 色素添加剂申请COLOR ADDITIVE PETITIONS
73 免除认证的色素添加剂的列表LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
74 适用认证的色素添加剂的列表LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
80 色素添加剂认证COLOR ADDITIVE CERTIFICATION
81 用于食品、药品和化妆品的临时性色素添加剂的一般规范和一般限制GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS
82 经认证的临时性列表的色素和规范的列表LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS
83-98 [预留的] [Reserved]
99 已上市的药品、生物制品和器械的未经批准的/新的用途的信息的发布DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
第B分章―用于人类消费的食品（SUBCHAPTER B―FOOD FOR HUMAN CONSUMPTION）
100 总则GENERAL
101 食品标识FOOD LABELING
102 非标准化食品的普通的或者通常的名称COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS
104 食品的营养质量指南NUTRITIONAL QUALITY GUIDELINES FOR FOODS
105 特殊膳食用途的食品FOODS FOR SPECIAL DIETARY USE
106 婴儿配方母乳替代食品质量控制程序INFANT FORMULA QUALITY CONTROL PROCEDURES
107 婴儿配方母乳替代食品INFANT FORMULA
108 紧急许可控制EMERGENCY PERMIT CONTROL
109 在人类食品与食品-包装材料中的不可避免的污染物UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL
110 在制造、包装或者保存人类食品中的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
113 装在密封容器中的热加工低酸食品THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS
114 酸化食品ACIDIFIED FOODS
115 带壳蛋SHELL EGGS
119 存在显著或者不合理风险的膳食补充剂DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK
120 危害分析与关键控制点（HACCP）体系HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS
123 鱼与渔业产品FISH AND FISHERY PRODUCTS
129 饮用水加工与装瓶PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER
130 食品标准：总则FOOD STANDARDS: GENERAL
131 乳与奶油MILK AND CREAM
133 乳酪与相关乳酪产品CHEESES AND RELATED CHEESE PRODUCTS
135 冷冻点心FROZEN DESSERTS
136 烘焙产品BAKERY PRODUCTS
137 谷物粉与相关产品CEREAL FLOURS AND RELATED PRODUCTS
139 通心粉与面条产品MACARONI AND NOODLE PRODUCTS
145 罐装水果CANNED FRUITS
146 罐装水果汁CANNED FRUIT JUICES
150 水果黄油、果冻、防腐剂以及相关产品FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS
152 水果馅饼FRUIT PIES
155 罐装蔬菜CANNED VEGETABLES
156 蔬菜汁VEGETABLE JUICES
158 冷冻蔬菜FROZEN VEGETABLES
160 蛋与蛋制品EGGS AND EGG PRODUCTS
161 鱼与有壳的水生动物FISH AND SHELLFISH
163 可可制品CACAO PRODUCTS
164 树坚果与花生制品TREE NUT AND PEANUT PRODUCTS
165 饮料BEVERAGES
166 人造黄油MARGARINE
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 在用于人类消费的食品中允许的次直接的食品添加剂SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION
174 间接食品添加剂：总则INDIRECT FOOD ADDITIVES: GENERAL
175 间接食品添加剂：胶粘剂与涂层的组分INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS
176 间接食品添加剂：纸与纸板组分INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
177 间接食品添加剂：聚合体INDIRECT FOOD ADDITIVES: POLYMERS
178 间接食品添加剂：辅剂、生产助剂和消毒剂INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS 179 在食品生产、加工和处理中的辐照IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD
180 在额外试验期间临时在食品或者在与食品接触中被允许的食品添加剂FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY
181 先前核准的食品配料PRIOR-SANCTIONED FOOD INGREDIENTS
182 一般认为安全的物质SUBSTANCES GENERALLY RECOGNIZED AS SAFE
184 被确认为一般认为安全的直接食品物质DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE 186 被确认为一般认为安全的间接食品物质INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE 189 禁止用于人类食品的物质SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD
190 膳食补充剂DIETARY SUPPLEMENTS
191-199 [预留的] [Reserved]
第C分章―药品：总则（SUBCHAPTER C―DRUGS: GENERAL）
200 总则GENERAL
201 标识LABELING
202 处方药广告PRESCRIPTION DRUG ADVERTISING
203 处方药销售PRESCRIPTION DRUG MARKETING
205 对批发处方药销售商颁发州执照的指南GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS
206 人用固体口服剂型药品的印码IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE
207 药品生产者的登记与商业销售的药品的列表REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION
208 处方药的药物治疗指导MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS
210 制造、加工、包装或者保存药品的现行良好制造规范；总则CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
211 对完成的药品的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
216 药房配药PHARMACY COMPOUNDING
225 对含药饲料的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
226 对A型含药物品的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES 250 对特殊人用药品的特殊要求SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS
290 管制的药品CONTROLLED DRUGS
299 药品；正式名称与已确定的名称DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES
第D分章―人用药品（SUBCHAPTER D―DRUGS FOR HUMAN USE）
300 总则GENERAL
310 新药NEW DRUGS
312 试验用新药申请INVESTIGATIONAL NEW DRUG APPLICATION
314 为FDA批准上市新药的申请APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
315 诊断用放射性药品DIAGNOSTIC RADIOPHARMACEUTICALS
316 罕见病药ORPHAN DRUGS
320 生物利用度与生物等效性要求BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
328 含有酒精的预期用于口部摄入的非处方药品OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL
330 一般认为安全与有效以及不错误标识的非处方人用药品OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
331 用于非处方的人类使用的抗酸产品ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
332 用于非处方的人类使用的抗胃肠气胀产品ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
333 用于非处方的人类使用的局部抗菌药品TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
335 用于非处方的人类使用的止泻药品ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
336 用于非处方的人类使用的止吐药品ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
338 用于非处方的人类使用的帮助夜间睡眠的药品NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
340 用于非处方的人类使用的兴奋药品STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
341 用于非处方的人类使用的感冒、咳嗽、过敏症药、支气管扩张以及平喘药品COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
343 用于非处方的人类使用的内服的止痛、退热以及抗风湿药品INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
344 用于非处方的人类使用的局部的耳部药品TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
346 用于非处方的人类使用的肛肠药品ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
347 用于非处方的人类使用的皮肤保护药品SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
348 用于非处方的人类使用的外部的止痛药品EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
349 用于非处方的人类使用的眼科药品OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
350 用于非处方的人类使用的止汗药品ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
352 用于非处方的人类使用的遮光药品SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]
355 用于非处方的人类使用的防龋药品ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
357 用于非处方的人类使用的其他内服药品MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
358 用于非处方的人类使用的其他外用药品MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
361 一般认为安全与有效以及不错误标识的处方人用药品：用于研究的药品PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY
RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH
369 在用于非处方销售的药品与器械上关于警告的解释性声明INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE
370-499 [预留的] [Reserved]
第E分章―动物药品、饮料和相关产品（SUB CHAPTER E―ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS）
500 总则GENERAL
501 动物食品标识ANIMAL FOOD LABELING
502 非标准化的动物食品的普通的或通常的名称COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS
509 在动物食品与食品-包装材料中的不可避免的污染物UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL
510 新动物药NEW ANIMAL DRUGS
511 作为试验用途的新动物药NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE
514 新动物药申请NEW ANIMAL DRUG APPLICATIONS
515 含药饲料厂执照MEDICATED FEED MILL LICENSE
520 口服剂型的新动物药ORAL DOSAGE FORM NEW ANIMAL DRUGS
522 植入或者注射剂型的新动物药IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
524 眼科和局部剂型的新动物药OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
526 乳房内的剂型INTRAMAMMARY DOSAGE FORMS
529 某些其他剂型的新动物药CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
530 在动物中的特别标签药品使用EXTRALABEL DRUG USE IN ANIMALS
556 在食品中新动物药残留的容许量TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
558 用于动物饲料的新动物药NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
564 [预留的] [Reserved]
570 食品添加剂FOOD ADDITIVES
571 食品添加剂申请FOOD ADDITIVE PETITIONS
573 在动物饲料与饮用水中允许的食品添加剂FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS
579 在动物饲料和宠物食品的生产、加工和处理中的辐照IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD
582 一般认为安全的物质SUBSTANCES GENERALLY RECOGNIZED AS SAFE
584 在动物饲料与饮用水中被确认为一般认为安全的食品物质FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS
589 禁止用于动物食品或者饲料的物质SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
590-599 [预留的] [Reserved]
第F分章―生物制品（SUB CHAPTER F―BIOLOGICS）
600 生物制品：总则BIOLOGICAL PRODUCTS: GENERAL
601 颁发执照LICENSING
606 对血液与血液组分的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
607 对人类血液与血液制品的制造者的机构登记与产品列表ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS
610 普通生物制品标准GENERAL BIOLOGICAL PRODUCTS STANDARDS
630 对血液、血液组分和血液衍生物的一般要求GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES
640 对人类血液和血液制品的附加标准ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
660 对用于实验室检测的诊断物质的附加标准ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
680 对其他产品的附加标准ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS
第G分章―化妆品（SUBCHAPTER G―COSMETICS）
700 总则GENERAL
701 化妆品标识COSMETIC LABELING
710 化妆品机构的自愿登记VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS
720 化妆品配料构成声明的自愿存档VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS
740 化妆品警告声明COSMETIC PRODUCT WARNING STATEMENTS
741-799 [预留的] [Reserved]
第H分章―医疗器械（SUBCHAPTER H―MEDICAL DEVICES）
800 总则GENERAL
801 标识LABELING
803 医疗器械报告MEDICAL DEVICE REPORTING
806 医疗器械；改正与移动的报告MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
807 对器械的制造者与首次进口者的机构登记与器械列表ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
808 对州和地方医疗器械要求的联邦优先权的豁免EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS
809 人用体外诊断产品IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
810 医疗器械召回权MEDICAL DEVICE RECALL AUTHORITY
812 试验用器械豁免INVESTIGATIONAL DEVICE EXEMPTIONS
813 [预留的] [Reserved]
814 医疗器械的上市前批准PREMARKET APPROVAL OF MEDICAL DEVICES
820 质量体系规章QUALITY SYSTEM REGULATION
821 医疗器械跟踪要求MEDICAL DEVICE TRACKING REQUIREMENTS
822 上市后监视POSTMARKET SURVEILLANCE
860 医疗器械分类程序MEDICAL DEVICE CLASSIFICATION PROCEDURES
861 性能标准制定程序PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
862 临床化学与临床毒理学器械CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
864 血液学与病理学器械HEMATOLOGY AND PATHOLOGY DEVICES
866 免疫学与微生物学器械IMMUNOLOGY AND MICROBIOLOGY DEVICES
868 麻醉学器械ANESTHESIOLOGY DEVICES
870 心血管器械CARDIOVASCULAR DEVICES
872 牙科器械DENTAL DEVICES
874 耳、鼻和咽器械EAR, NOSE, AND THROAT DEVICES
876 胃肠病学-泌尿学器械GASTROENTEROLOGY-UROLOGY DEVICES
878 普通与整形外科器械GENERAL AND PLASTIC SURGERY DEVICES
880 普通医院与个人使用器械GENERAL HOSPITAL AND PERSONAL USE DEVICES
882 神经学器械NEUROLOGICAL DEVICES
884 产科与妇科学器械OBSTETRICAL AND GYNECOLOGICAL DEVICES
886 眼科器械OPHTHALMIC DEVICES
888 矫形外科器械ORTHOPEDIC DEVICES
890 内科学器械PHYSICAL MEDICINE DEVICES
892 放射学器械RADIOLOGY DEVICES
895 禁止的器械BANNED DEVICES
898 电极铅线与患者电缆的性能标准PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES
第I分章―乳房造影质量标准法（SUBCHAPTER I―MAMMOGRAPHY QUALITY STANDA RDS ACT）
900 乳房造影法MAMMOGRAPHY
第J分章―放射学的健康（SUBCHAPTER J―RADIOLOGICAL HEALTH）
1000 总则GENERAL
1002 记录与报告RECORDS AND REPORTS
1003 缺陷与未能守法的通报NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
1004 电子产品的回购、修理或者置换REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS
1005 电子产品的进口IMPORTATION OF ELECTRONIC PRODUCTS
1010 电子产品的性能标准：总则PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL
1020 电离辐射发生产品的性能标准PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS
1030 微波与射电频率发生产品的性能标准PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS
1040 发光产品的性能标准PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
1050 声波、次声波和超声波发生产品的性能标准PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC 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）
1210 根据《联邦进口乳法》的规章REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT
1230 根据《联邦腐蚀性毒物法》的规章REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT
1240 传染病的控制CONTROL OF COMMUNICABLE DISEASES
1250 州际运输卫生INTERSTATE CONVEYANCE SANITATION
1251-1269 [预留的] [Reserved]
1270 预期用于移植的人体组织HUMAN TISSUE INTENDED FOR TRANSPLANTATION
1271 人体细胞、组织以及细胞的和基于组织的产品HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS 1272-1299 [预留的] [Reserved]
第Ⅱ章―司法部毒品强制执行局（CHAPTER Ⅱ―DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE）
1300 定义DEFINITIONS
1301 管制物质的制造者、分销者和调剂者的登记REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
1302 对管制物质的标识与包装要求LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES
1303 定额QUOTAS
1304 登记者的记录与报告RECORDS AND REPORTS OF REGISTRANTS
1305 令的格式ORDER FORMS
1306 处方PRESCRIPTIONS
1307 杂项MISCELLANEOUS
1308 管制物质的表SCHEDULES OF CONTROLLED SUBSTANCES
1309 表I化学品的制造者、分销者、进口者和出口者的登记REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS
1310 列入表的化学品和某些机器的记录与报告RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES 1311 [预留的] [Reserved]
1312 管制物质的进口与出口IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES
1313 前体与必要化学品的进口与出口IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL CHEMICALS
1314-1315 [预留的] [Reserved]
1316 行政职能、规范和程序ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES
第Ⅲ章―毒品控制政策办公室（CHAPTER Ⅲ―Office of National Drug Control Policy）
1400 [预留的] [Reserved]
1401 信息的公众可及性PUBLIC AVAILABILITY OF INFORMATION
1402 强制性解密审查MANDATORY DECLASSIFICATION REVIEW
1403 对给予州和地方政府资金和合作协议的统一行政要求UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE AGREEMENTS TO STATE AND LOCAL GOVERNMENTS
1404 政府范围的排除与暂停（非获得）GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)
1405 对无毒品工作场所的政府范围的要求（财政援助）GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE)
1406-1499 [预留的] [Reserved]