|  
| ENGLISH | 加入收藏 | 设为首页 | 站内地图   
    
 NB1282

CE认证

 医疗器械检测

  CFDA注册

 FDA认证

 

  欢迎登陆上海欧杰医疗器械认证网! 专注于医疗器械产品认证与咨询12年!

 
关键词:CE认证,FDA认证,MDR认证
 
您当前位置:MDR认证FDA认证注册中心 >> 美国FDA认证 >> 浏览文章

美国《联邦规章典集》(CFR)第21篇“食品与药品”总目

日期:2018-02-23 16:47:36 来源:本站原创   【字体:

 

概述:美国《联邦规章典集》(Code of Federal RegulationsCFR)第21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 AdministrationDepartment 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 AdministrationDepartment 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。

21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 Ⅰ 1-99 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 Ⅱ 1300-1399
司法部毒品强制执行局(Drug Enforcement AdministrationDepartment of Justice
Ⅲ 1400-1499 毒品控制政策办公室(Office of National Drug Control Policy

21食品与药品Title 21―Food and Drugs)的章、部目录
(Part) 中译文 原英文
健康与人类服务部食品与药品管理局(CHAPTER Ⅰ―FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
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
FDA局长前的公众听证 PUBLIC HEARING BEFORE THE COMMISSIONER
16
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   
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]
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
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   
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
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]
E分章动物药品、饮料和相关产品(SUBCHAPTER 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]  
F分章生物制品(SUBCHAPTER 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   
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]  
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   
I分章乳房造影质量标准法(SUBCHAPTER I―MAMMOGRAPHY QUALITY STANDARDS ACT
900 乳房造影法 MAMMOGRAPHY
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   
K分章―[预留的]SUBCHAPTER K―[RESERVED]
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]
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
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   
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]

上一篇:FDA工厂检查安排 下一篇:没有了
 

相关文章:

 
返回首页

 

 

 

 

 

 

 
精品认证
 欧盟CE认证
 
 中国CFDA认证
 
 美国FDA认证
 
 ISO13485品认证
 
 GMP认证
 
 
 
 
  
 
联系方式
电话:021-37829967
      021-37633862
传真:021-37633862
QQ:   1206693898
微信号: 18602151536
业务联系: 黄经理