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美国FDA《联邦规章典集》(CFR)第21篇目录中文版(二)

阅读: 2017年07月13日

美国FDA《联邦规章典集》(CFR)第21篇目录中文版(二)

 

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说明性声明 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(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]

第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

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 STANDARDS 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实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―司法部毒品强制实行局(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]




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