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美國《聯(lián)邦規(guī)章典集》（CFR）第21篇“食品與藥品”總目
概述：美國《聯(lián)邦規(guī)章典集》（Code of Federal
Regulations，CFR）第21篇“食品與藥品”（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，為健康與人類服務(wù)
部食品與藥品管理局（Food and Drug Administration，Department of Health and Human
Services）的規(guī)章；第9卷第2章第1300―1399部，為司法部毒品強制執(zhí)行局（Drug Enforcement
Administration，Department of
Justice）的規(guī)章；第9卷第3章第1400―1499部，為毒品控制政策辦公室（Office of National Drug Control
Policy）的規(guī)章。
第21篇“食品與藥品”（Title 21―Food and Drugs）的概況
卷（Volume） 章（Chapter） 部（Parts） 規(guī)制機關(guān)（Regulatory Entity）
1 Ⅰ 1-99 健康與人類服務(wù)部食品與藥品管理局（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 司法部毒品強制執(zhí)行局（Drug Enforcement Administration，Department of Justice）
Ⅲ 1400-1499 毒品控制政策辦公室（Office of National Drug Control Policy）
部(Part) 中譯文 原英文
第Ⅰ章―健康與人類服務(wù)部食品與藥品管理局（CHAPTER Ⅰ―FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES）
第A分章―總則（SUBCHAPTER A―GENERAL）
1 一般強制執(zhí)行規(guī)章 GENERAL ENFORCEMENT REGULATIONS
2 一般行政規(guī)則與決定 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
3 產(chǎn)品管轄權(quán) PRODUCT JURISDICTION
5 組織 ORGANIZATION
7 強制執(zhí)行政策 ENFORCEMENT POLICY
10 行政規(guī)范與程序 ADMINISTRATIVE PRACTICES AND PROCEDURES
11 電子化記錄；電子化簽名 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
12 正式證據(jù)的公眾聽證 FORMAL EVIDENTIARY PUBLIC HEARING
13 在公眾質(zhì)詢委員會前的公眾聽證 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY
14 在公眾咨詢委員會前的公眾聽證 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
15 在FDA局長前的公眾聽證 PUBLIC HEARING BEFORE THE COMMISSIONER
16 在FDA前的規(guī)制性聽證 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
17 行政罰款聽證 CIVIL MONEY PENALTIES HEARINGS
19 行為標(biāo)準(zhǔn)與利益沖突 STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST
20 公共信息 PUBLIC INFORMATION
21 隱私保護 PROTECTION OF PRIVACY
25 環(huán)境影響考慮 ENVIRONMENTAL IMPACT CONSIDERATIONS
26 藥品良好制造規(guī)范報告、醫(yī)療器械質(zhì)量體系核查報告以及某些醫(yī)療器械產(chǎn)品評價報告的互認：美國與歐共體 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 人類受試者的保護 PROTECTION OF HUMAN SUBJECTS
54 臨床試驗者的財務(wù)公開 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
56 機構(gòu)審查委員會 INSTITUTIONAL REVIEW BOARDS
58 對非臨床實驗室研究的良好實驗室規(guī)范 GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
60 專利期恢復(fù) PATENT TERM RESTORATION
70 色素添加劑 COLOR ADDITIVES
71 色素添加劑申請 COLOR ADDITIVE PETITIONS
73 免除認證的色素添加劑的列表 LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
74 適用認證的色素添加劑的列表 LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
80 色素添加劑認證 COLOR ADDITIVE CERTIFICATION
81 用于食品、藥品和化妝品的臨時性色素添加劑的一般規(guī)范和一般限制 GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS
82 經(jīng)認證的臨時性列表的色素和規(guī)范的列表 LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS
83-98 [預(yù)留的] [Reserved]
99 已上市的藥品、生物制品和器械的未經(jīng)批準(zhǔn)的/新的用途的信息的發(fā)布 DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
第B分章―用于人類消費的食品（SUBCHAPTER B―FOOD FOR HUMAN CONSUMPTION）
100 總則 GENERAL
101 食品標(biāo)識 FOOD LABELING
102 非標(biāo)準(zhǔn)化食品的普通的或者通常的名稱 COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS
104 食品的營養(yǎng)質(zhì)量指南 NUTRITIONAL QUALITY GUIDELINES FOR FOODS
105 特殊膳食用途的食品 FOODS FOR SPECIAL DIETARY USE
106 嬰兒配方母乳替代食品質(zhì)量控制程序 INFANT FORMULA QUALITY CONTROL PROCEDURES
107 嬰兒配方母乳替代食品 INFANT FORMULA
108 緊急許可控制 EMERGENCY PERMIT CONTROL
109 在人類食品與食品-包裝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、包裝或者保存人類食品中的現(xiàn)行良好制造規(guī)范 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
113 裝在密封容器中的熱加工低酸食品 THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS
114 酸化食品 ACIDIFIED FOODS
115 帶殼蛋 SHELL EGGS
119 存在顯著或者不合理風(fēng)險的膳食補充劑 DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK
120 危害分析與關(guān)鍵控制點（HACCP）體系 HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS
123 魚與漁業(yè)產(chǎn)品 FISH AND FISHERY PRODUCTS
129 飲用水加工與裝瓶 PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER
130 食品標(biāo)準(zhǔn)：總則 FOOD STANDARDS: GENERAL
131 乳與奶油 MILK AND CREAM
133 乳酪與相關(guān)乳酪產(chǎn)品 CHEESES AND RELATED CHEESE PRODUCTS
135 冷凍點心 FROZEN DESSERTS
136 烘焙產(chǎn)品 BAKERY PRODUCTS
137 谷物粉與相關(guān)產(chǎn)品 CEREAL FLOURS AND RELATED PRODUCTS
139 通心粉與面條產(chǎn)品 MACARONI AND NOODLE PRODUCTS
145 罐裝水果 CANNED FRUITS
146 罐裝水果汁 CANNED FRUIT JUICES
150 水果黃油、果凍、防腐劑以及相關(guān)產(chǎn)品 FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS
152 水果餡餅 FRUIT PIES
155 罐裝蔬菜 CANNED VEGETABLES
156 蔬菜汁 VEGETABLE JUICES
158 冷凍蔬菜 FROZEN VEGETABLES
160 蛋與蛋制品 EGGS AND EGG PRODUCTS
161 魚與有殼的水生動物 FISH AND SHELLFISH
163 可可制品 CACAO PRODUCTS
164 樹堅果與花生制品 TREE NUT AND PEANUT PRODUCTS
165 飲料 BEVERAGES
166 人造黃油 MARGARINE
168 增甜劑與餐桌糖漿 SWEETENERS AND TABLE SIRUPS
169 食品敷料與調(diào)味料 FOOD DRESSINGS AND FLAVORINGS
170 食品添加劑 FOOD ADDITIVES
171 食品添加劑申請 FOOD ADDITIVE PETITIONS
172 允許直接加入用于人類消費食品的食品添加劑 FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
173 在用于人類消費的食品中允許的次直接的食品添加劑 SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION
174 間接食品添加劑：總則 INDIRECT FOOD ADDITIVES: GENERAL
175 間接食品添加劑：膠粘劑與涂層的組分 INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS
176 間接食品添加劑：紙與紙板組分 INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
177 間接食品添加劑：聚合體 INDIRECT FOOD ADDITIVES: POLYMERS
178 間接食品添加劑：輔劑、生產(chǎn)助劑和消毒劑 INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
179 在食品生產(chǎn)、加工和處理中的輻照 IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD
180 在額外試驗期間臨時在食品或者在與食品接觸中被允許的食品添加劑 FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY
181 先前核準(zhǔn)的食品配料 PRIOR-SANCTIONED FOOD INGREDIENTS
182 一般認為安全的物質(zhì) SUBSTANCES GENERALLY RECOGNIZED AS SAFE
184 被確認為一般認為安全的直接食品物質(zhì) DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
186 被確認為一般認為安全的間接食品物質(zhì) INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
189 禁止用于人類食品的物質(zhì) SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD
190 膳食補充劑 DIETARY SUPPLEMENTS
191-199 [預(yù)留的] [Reserved]
第C分章―藥品：總則（SUBCHAPTER C―DRUGS: GENERAL）
200 總則 GENERAL
201 標(biāo)識 LABELING
202 處方藥廣告 PRESCRIPTION DRUG ADVERTISING
203 處方藥銷售 PRESCRIPTION DRUG MARKETING
205 對批發(fā)處方藥銷售商頒發(fā)州執(zhí)照的指南 GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS
206 人用固體口服劑型藥品的印碼 IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE
207 藥品生產(chǎn)者的登記與商業(yè)銷售的藥品的列表 REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION
208 處方藥的藥物治療指導(dǎo) MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS
210 制造、加工、包裝或者保存藥品的現(xiàn)行良好制造規(guī)范；總則 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
211 對完成的藥品的現(xiàn)行良好制造規(guī)范 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
216 藥房配藥 PHARMACY COMPOUNDING
225 對含藥飼料的現(xiàn)行良好制造規(guī)范 CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
226 對A型含藥物品的現(xiàn)行良好制造規(guī)范 CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
250 對特殊人用藥品的特殊要求 SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS
290 管制的藥品 CONTROLLED DRUGS
299 藥品；正式名稱與已確定的名稱 DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES
第D分章―人用藥品（SUBCHAPTER D―DRUGS FOR HUMAN USE）
300 總則 GENERAL
310 新藥 NEW DRUGS
312 試驗用新藥申請 INVESTIGATIONAL NEW DRUG APPLICATION
314 為FDA批準(zhǔn)上市新藥的申請 APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
315 診斷用放射性藥品 DIAGNOSTIC RADIOPHARMACEUTICALS
316 罕見病藥 ORPHAN DRUGS
320 生物利用度與生物等效性要求 BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
328 含有酒精的預(yù)期用于口部攝入的非處方藥品 OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL
330 一般認為安全與有效以及不錯誤標(biāo)識的非處方人用藥品 OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
331 用于非處方的人類使用的抗酸產(chǎn)品 ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
332 用于非處方的人類使用的抗胃腸氣脹產(chǎn)品 ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
333 用于非處方的人類使用的局部抗菌藥品 TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
335 用于非處方的人類使用的止瀉藥品 ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
336 用于非處方的人類使用的止吐藥品 ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
338 用于非處方的人類使用的幫助夜間睡眠的藥品 NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
340 用于非處方的人類使用的興奮藥品 STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
341 用于非處方的人類使用的感冒、咳嗽、過敏癥藥、支氣管擴張以及平喘藥品 COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
343 用于非處方的人類使用的內(nèi)服的止痛、退熱以及抗風(fēng)濕藥品 INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
344 用于非處方的人類使用的局部的耳部藥品 TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
346 用于非處方的人類使用的肛腸藥品 ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
347 用于非處方的人類使用的皮膚保護藥品 SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
348 用于非處方的人類使用的外部的止痛藥品 EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
349 用于非處方的人類使用的眼科藥品 OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
350 用于非處方的人類使用的止汗藥品 ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
352 用于非處方的人類使用的遮光藥品 SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]
355 用于非處方的人類使用的防齲藥品 ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
357 用于非處方的人類使用的其他內(nèi)服藥品 MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
358 用于非處方的人類使用的其他外用藥品 MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
361 一般認為安全與有效以及不錯誤標(biāo)識的處方人用藥品：用于研究的藥品 PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH
369 在用于非處方銷售的藥品與器械上關(guān)于警告的解釋性聲明 INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE
370-499 [預(yù)留的] [Reserved]
第E分章―動物藥品、飲料和相關(guān)產(chǎn)品（SUBCHAPTER E―ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS）
500 總則 GENERAL
501 動物食品標(biāo)識 ANIMAL FOOD LABELING
502 非標(biāo)準(zhǔn)化的動物食品的普通的或通常的名稱 COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS
509 在動物食品與食品-包裝材料中的不可避免的污染物 UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL
510 新動物藥 NEW ANIMAL DRUGS
511 作為試驗用途的新動物藥 NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE
514 新動物藥申請 NEW ANIMAL DRUG APPLICATIONS
515 含藥飼料廠執(zhí)照 MEDICATED FEED MILL LICENSE
520 口服劑型的新動物藥 ORAL DOSAGE FORM NEW ANIMAL DRUGS
522 植入或者注射劑型的新動物藥 IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
524 眼科和局部劑型的新動物藥 OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
526 乳房內(nèi)的劑型 INTRAMAMMARY DOSAGE FORMS
529 某些其他劑型的新動物藥 CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
530 在動物中的特別標(biāo)簽藥品使用 EXTRALABEL DRUG USE IN ANIMALS
556 在食品中新動物藥殘留的容許量 TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
558 用于動物飼料的新動物藥 NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
564 [預(yù)留的] [Reserved]
570 食品添加劑 FOOD ADDITIVES
571 食品添加劑申請 FOOD ADDITIVE PETITIONS
573 在動物飼料與飲用水中允許的食品添加劑 FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS
579 在動物飼料和寵物食品的生產(chǎn)、加工和處理中的輻照 IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD
582 一般認為安全的物質(zhì) SUBSTANCES GENERALLY RECOGNIZED AS SAFE
584 在動物飼料與飲用水中被確認為一般認為安全的食品物質(zhì) FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS
589 禁止用于動物食品或者飼料的物質(zhì) SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
590-599 [預(yù)留的] [Reserved]
第F分章―生物制品（SUBCHAPTER F―BIOLOGICS）
600 生物制品：總則 BIOLOGICAL PRODUCTS: GENERAL
601 頒發(fā)執(zhí)照 LICENSING
606 對血液與血液組分的現(xiàn)行良好制造規(guī)范 CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
607 對人類血液與血液制品的制造者的機構(gòu)登記與產(chǎn)品列表 ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS
610 普通生物制品標(biāo)準(zhǔn) GENERAL BIOLOGICAL PRODUCTS STANDARDS
630 對血液、血液組分和血液衍生物的一般要求 GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES
640 對人類血液和血液制品的附加標(biāo)準(zhǔn) ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
660 對用于實驗室檢測的診斷物質(zhì)的附加標(biāo)準(zhǔn) ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
680 對其他產(chǎn)品的附加標(biāo)準(zhǔn) ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS
第G分章―化妝品（SUBCHAPTER G―COSMETICS）
700 總則 GENERAL
701 化妝品標(biāo)識 COSMETIC LABELING
710 化妝品機構(gòu)的自愿登記 VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS
720 化妝品配料構(gòu)成聲明的自愿存檔 VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS
740 化妝品警告聲明 COSMETIC PRODUCT WARNING STATEMENTS
741-799 [預(yù)留的] [Reserved]
第H分章―醫(yī)療器械（SUBCHAPTER H―MEDICAL DEVICES）
800 總則 GENERAL
801 標(biāo)識 LABELING
803 醫(yī)療器械報告 MEDICAL DEVICE REPORTING
806 醫(yī)療器械；改正與移動的報告 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
807 對器械的制造者與首次進口者的機構(gòu)登記與器械列表 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
808 對州和地方醫(yī)療器械要求的聯(lián)邦優(yōu)先權(quán)的豁免 EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS
809 人用體外診斷產(chǎn)品 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
810 醫(yī)療器械召回權(quán) MEDICAL DEVICE RECALL AUTHORITY
812 試驗用器械豁免 INVESTIGATIONAL DEVICE EXEMPTIONS
813 [預(yù)留的] [Reserved]
814 醫(yī)療器械的上市前批準(zhǔn) PREMARKET APPROVAL OF MEDICAL DEVICES
820 質(zhì)量體系規(guī)章 QUALITY SYSTEM REGULATION
821 醫(yī)療器械跟蹤要求 MEDICAL DEVICE TRACKING REQUIREMENTS
822 上市后監(jiān)視 POSTMARKET SURVEILLANCE
860 醫(yī)療器械分類程序 MEDICAL DEVICE CLASSIFICATION PROCEDURES
861 性能標(biāo)準(zhǔn)制定程序 PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
862 臨床化學(xué)與臨床毒理學(xué)器械 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
864 血液學(xué)與病理學(xué)器械 HEMATOLOGY AND PATHOLOGY DEVICES
866 免疫學(xué)與微生物學(xué)器械 IMMUNOLOGY AND MICROBIOLOGY DEVICES
868 麻醉學(xué)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 胃腸病學(xué)-泌尿?qū)W器械 GASTROENTEROLOGY-UROLOGY DEVICES
878 普通與整形外科器械 GENERAL AND PLASTIC SURGERY DEVICES
880 普通醫(yī)院與個人使用器械 GENERAL HOSPITAL AND PERSONAL USE DEVICES
882 神經(jīng)學(xué)器械 NEUROLOGICAL DEVICES
884 產(chǎn)科與婦科學(xué)器械 OBSTETRICAL AND GYNECOLOGICAL DEVICES
886 眼科器械 OPHTHALMIC DEVICES
888 矯形外科器械 ORTHOPEDIC DEVICES
890 內(nèi)科學(xué)器械 PHYSICAL MEDICINE DEVICES
892 放射學(xué)器械 RADIOLOGY DEVICES
895 禁止的器械 BANNED DEVICES
898 電極鉛線與患者電纜的性能標(biāo)準(zhǔn) PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES
第I分章―乳房造影質(zhì)量標(biāo)準(zhǔn)法（SUBCHAPTER I―MAMMOGRAPHY QUALITY STANDARDS ACT）
900 乳房造影法 MAMMOGRAPHY
第J分章―放射學(xué)的健康（SUBCHAPTER J―RADIOLOGICAL HEALTH）
1000 總則 GENERAL
1002 記錄與報告 RECORDS AND REPORTS
1003 缺陷與未能守法的通報 NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
1004 電子產(chǎn)品的回購、修理或者置換 REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS
1005 電子產(chǎn)品的進口 IMPORTATION OF ELECTRONIC PRODUCTS
1010 電子產(chǎn)品的性能標(biāo)準(zhǔn)：總則 PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL
1020 電離輻射發(fā)生產(chǎn)品的性能標(biāo)準(zhǔn) PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS
1030 微波與射電頻率發(fā)生產(chǎn)品的性能標(biāo)準(zhǔn) PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS
1040 發(fā)光產(chǎn)品的性能標(biāo)準(zhǔn) PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
1050 聲波、次聲波和超聲波發(fā)生產(chǎn)品的性能標(biāo)準(zhǔn) PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS
第K分章―[預(yù)留的]（SUBCHAPTER K―[RESERVED]）
第 L分章―根據(jù)由食品與藥品管理局行政執(zhí)行的某些其他法的規(guī)章（SUBCHAPTER L―REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION）
1210 根據(jù)《聯(lián)邦進口乳法》的規(guī)章 REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT
1230 根據(jù)《聯(lián)邦腐蝕性毒物法》的規(guī)章 REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT
1240 傳染病的控制 CONTROL OF COMMUNICABLE DISEASES
1250 州際運輸衛(wèi)生 INTERSTATE CONVEYANCE SANITATION
1251-1269 [預(yù)留的] [Reserved]
1270 預(yù)期用于移植的人體組織 HUMAN TISSUE INTENDED FOR TRANSPLANTATION
1271 人體細胞、組織以及細胞的和基于組織的產(chǎn)品 HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
1272-1299 [預(yù)留的] [Reserved]
第Ⅱ章―司法部毒品強制執(zhí)行局（CHAPTER Ⅱ―DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE）
1300 定義 DEFINITIONS
1301 管制物質(zhì)的制造者、分銷者和調(diào)劑者的登記 REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
1302 對管制物質(zhì)的標(biāo)識與包裝要求 LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES
1303 定額 QUOTAS
1304 登記者的記錄與報告 RECORDS AND REPORTS OF REGISTRANTS
1305 令的格式 ORDER FORMS
1306 處方 PRESCRIPTIONS
1307 雜項 MISCELLANEOUS
1308 管制物質(zhì)的表 SCHEDULES OF CONTROLLED SUBSTANCES
1309 表I化學(xué)品的制造者、分銷者、進口者和出口者的登記 REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS
1310 列入表的化學(xué)品和某些機器的記錄與報告 RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES
1311 [預(yù)留的] [Reserved]
1312 管制物質(zhì)的進口與出口 IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES
1313 前體與必要化學(xué)品的進口與出口 IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL CHEMICALS
1314-1315 [預(yù)留的] [Reserved]
1316 行政職能、規(guī)范和程序 ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES
第Ⅲ章―毒品控制政策辦公室（CHAPTER Ⅲ―Office of National Drug Control Policy）
1400 [預(yù)留的] [Reserved]
1401 信息的公眾可及性 PUBLIC AVAILABILITY OF INFORMATION
1402 強制性解密審查 MANDATORY DECLASSIFICATION REVIEW
1403 對給予州和地方政府資金和合作協(xié)議的統(tǒng)一行政要求 UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE AGREEMENTS TO STATE AND LOCAL GOVERNMENTS
1404 政府范圍的排除與暫停（非獲得） GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)
1405 對無毒品工作場所的政府范圍的要求（財政援助） GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE)
1406-1499 [預(yù)留的] [Reserved]
