21CFR820.[中文版本]
21 CFR 820 美国FDA,质量体系(QS)法规医疗器械良好生产规范(中文),2020年5月最新版
标题21-食物和毒品第一章-食品和药物管理局卫生和人类服务部第h章-医疗设备第820部分质量体系监管A部分----一般规定秘书。
820.1范围。
(a)适用性。
（1）本质量体系条例规定了现行良好制造做法要求。
本部分的要求指导所有用于人类使用的成品设备的设计、制造、包装、标签、储存、安装和维修所使用的方法以及所使用的设施和控制。
本部分的要求旨在确保成品设备将是安全和有效的，否则符合联邦食品、药品和化妆品法案（该法案）。
本部分确立了适用于成品医疗器械生产厂家的基本要求..如果制造商只从事符合本部分要求的某些操作，而不是其他操作，则该制造商只需遵守适用于其所从事操作的要求。
关于I类设备，设计控制只适用于820.30(A)（2）中列出的设备。
本条例不适用于部件制造商或成品设备部件制造商，但鼓励这些制造商使用本条例的适当规定作为指导。
用于输血或进一步制造的血液和血液成分的制造商不受本部分的限制，但受本章F节的限制。
本章第1271.3(d)段所界定的人体细胞、组织、细胞和组织产品制造商，即医疗设备（根据该法的设备规定提交的申请或根据《公共卫生服务法》第351节提交的生物产品许可证申请，须接受市场前审查或通知，或免于通知），均须遵守本章第1271节C部分所规定的供者资格程序适用本章第1271节D部分现行良好做法程序。
如果第1271部分和本章其他部分中的适用条例发生冲突，则具体适用于该装置的条例应取代较一般的条例。
（2）本部分的规定适用于在美国任何州或领土、哥伦比亚特区或波多黎各自由邦制造、进口或提供进口的本部分所界定的供人类使用的任何成品装置。
（3）本条例多次使用“酌情”一词。
如果一项要求被“酌情”限定，则被认为是“适当的”，除非制造商可以另有证明。
如果合理地预期不实施会导致产品不符合其规定的要求或制造商无法采取任何必要的纠正行动，则要求是“适当的”。
(b)本部分的质量体系条例补充了本章其他部分的规定，但另有明确说明的除外。
美国FDA 21CFR820法规培训
（a）总则
（1）任何三类或二类器械，以及在本节（a）的（2）中列明的一类 器械，这些器械制造商应建立并维护器械设计控制程序，以确保满足 特定的设计要求。
（2）以下一类器械应遵循设计控制；
（i）由计算机软件自动操作的器械
（ii）列于下表的器械
868.6810 支气管引流管
878.4460外科医师手套
880.6760 防护性限位器
• 这些要求是为了确保医疗器械成品的安全和有效，并遵 从美国食品、药品和化妆品法。
PART 02
21CFR820适用范围
21CFR820适用范围
本法规的基本要求适用于所有的最终医疗器械制造 商。如果制造商仅从事本法规中的某些过程而不从 事其它过程，则制造商只需要遵守适用于其实施过 程的要求。
不适用于最终产品的部件或零件制造商，但鼓励此 类制造商适用本法规中的适用条款作为指南。
制造商应建立并保持要求，包括健康、清洁、个人行为和人员的服 装要求。如果此类人员与产品接触，或者环境条件能够对产品质量产 生不利的影响，制造商应确保维护和其它需要暂时在特定环境下工作 的临时人员受到适当的培训或受到专人的监督指导。
（e）污染控制
制造商应建立并保持程序，防止可能会对产品质量产生不利影响的 设备或产品的污染。
（1）文件化指引、标准操作规程以及定义并控制生产方式的方法；
（2）在生产过程中，监测和控制过程参数、组件和器械特性；
（3）符合相关的标准或法规；
（4）过程和加工设备的批准；
（5）标准的工艺，应在文件化的标准中加以明确，或通过标识批准 的代表性样品的加以明确。
21CFR820条款讲解——G生产及过程控制
FDA 21CFR820法规培训
针对21CFRPart820法规的讲解
针对21 CFR Part 820法规的讲解一、FDA的定义FDA（U.S. Food and Drug Administration）的简称，即美国食品药品监督管理局。
它是健康与人类服务部下属的一个机构，由各个中心、办公室、地区办公室以及海外办公室组成。
二、联邦法规条例，第21册相关法规说明21 CFR Part 11 电子签名、电子记录（FDA检查时尽量避免给电子档文件）。
21 CFR Part 71.73.74.80 颜色添加剂。
21 CFR Part 58 良好的实验室规范。
21 CFR Part 50 受试者的保护。
21 CFR Part 801 医疗器械标识。
21 CFR Part 807 注册、列示、510（K）510（K）主要是针对产品的许可，包括了产品的生产商、配件生产商、一级销售商，任何一个独立地址的生产厂都必须向FDA注册。
列示：是指针对销售美国的所有产品都要列示。
21 CFR Part 814 上市前许可。
21 CFR Part 803 医疗器械报告。
21 CFR Part 806 纠正与移除。
21 CFR Part 820 质量体系法规。
21 CFR Part 821 医疗器械追踪。
三、第820部分质量体系法规条款框架（共15部分，31章节）（a）适用性（b）法规说明820.1范围（c）权威性（d）外国制造商A部分总则（e）豁免或改变820.3定义820.5质量体系（a）质量方针（1）职责和权限（b）组织（2）资源820.30管理职责（c）管理评审（3）管理者代表B部分质量体系要求820.22质量审核（d）质量策划（e）质量体系程序820.25人员（a）总则（b）培训（a）总则（b）设计和开发策划（c）设计输入（d）设计输出（e）设计评审C部分设计控制----- 820.30设计控制（f）设计验证（g）设计确认（h）设计转换（i）设计更改（j）设计历史文档（a）文件批准和分发D部分文件控制----- 820.40文件控制（b）文件更改（a）采购、承包方和顾问的评价E部分采购控制----- 820.50采购控制（b）采购资料820.60标识F部分标识和可追溯性820.65 可追溯性（a）总则（b）生产和过程更改（c）环境控制（d）人员820.70 生产和过程控制（e）污染控制（f）建筑物1）维护计划（g）设备（2）检查（h）制造物料（3）调整（i）自动化过程G部分生产和过程控制（a）检验、测量和试验装置控制820.72校验、测量和试验装置（1）校准标准（b）校准（2）校准记录820.75过程确认（a）总则（b）进货验收活动820.80 进货、过程中和成品（c）过程中验收活动器械的验收（d）最终验收活动H部分验收活动（e）验收记录820.86 验收状态（a）不合格产品控制I部分不合格产品------ 820.90 不合格产品（b）不合格评审和处置J部分纠正和预防措施----820.100纠正和预防措施（a）标签完整性（b）标记检验820.120 器械标识（c）标识存储K部分标识和包装控制（d）标签作业820.130 器械包装（e）控制号820.140 搬运（a）对存储区规定文件820.150 存储L部分搬运、存储、分销和包装820.160 分销（b）物料收发方法规定文件820.170 安装（a）机密性820.180 通用要求（b）记录保存期限（1）管理评审（c）例外（2）质量审核（a）器械规范（3）供方审核（b）生产过程规范820.181 器械主记录（c）质量保证程序和规范（d）包装和标识规范（e）安装、维护和服务程序及方法（a）制造日期M部分记录（b）制造数量820.184器械的历史记录（c）放行分销的数量（d）验收记录（e）器械上的主要标签和标识记录（f）器械唯一标识UDI和产品代码UPC820.186 质量体系记录1、抱怨接收流程820.198 抱怨文档2、抱怨评估流程3、抱怨审核流程N部分服务----- 820.200 服务O部分统计技术----- 820.250 统计技术。
21CFR 820中文版
Sec.820.25 人员
（a） 概述。制造商应有足够的人员，经过必要的教育、工作背景、专业培训和相关的经验，以保证所有法规要求的活动能够得到正确的执动应符合的要求。
（z） 确认Validation。通过检查和提供客观证据证明满足预期用途的要求。
（1） 过程确认Process validation。根据客观证据确定过程可持续产生满足预先确定规范的结果或产品。
（2） 设计确认Design validation。根据客观证据确定设备规范符合使用者的需求和预期用途。
（v） 质量体系Quality system。质量管理的组织结构、职责、程序、过程和资源。
（w） Remanufacturer。指对最终产品进行处理、修整、修复、重新包装、恢复或其它活动的人，使最终产品的性能、安全规范或预期用途产生重大更改。
（x） 返工Rework。为使不合格品在其交付前符合DMR的要求而采取的措施。
（h） 设计评审Design review。是指对设计的一个文件化的、全面的、系统的检查，评价其满足设计要求，评价其有能力满足要求，并识别任何问题。
（i） 设备历史记录Device history record（DHR）。最终产品历史记录的汇总。
（j） Device master record（DMR）。最终产品的程序和规范的汇总。
（b） 投诉Complaint。在设备交付后所有的书面的、电子的或口头的，对设备的特性、质量、耐久性、安全性、有效性方面不满意的信息。
（c） 部件Component。所有成为最终、包装、标识的设备的一部分的原材料、物资、件、部分、软件、连接件、标签或它们的集合。
（d） 控制号Control number。唯一性标识，如由字母、数字或它们的组合形成的唯一性组合，由控制号可以确定一批或一个设备的制造、包装、标签和交付的历史。
21 CFR 820 美国FDA,质量体系(QS)法规医疗器械良好生产规范(英文),2020年5月最新版
TITLE21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER H--MEDICAL DEVICESPART820QUALITY SYSTEM REGULATIONSubpart A--General ProvisionsSec.820.1Scope.(a)Applicability.(1)Current good manufacturing practice(CGMP)requirements are set forth in this quality system regulation.The requirements in this part govern the methods used in,and the facilities and controls used for,the design, manufacture,packaging,labeling,storage,installation,and servicing of all finished devices intended for human use.The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food,Drug,and Cosmetic Act(the act).This part establishes basic requirements applicable to manufacturers of finished medical devices.If a manufacturer engages in only some operations subject to the requirements in this part,and not in others,that manufacturer need only comply with those requirements applicable to the operations in which it is engaged.With respect to class I devices,design controls apply only to those devices listed in820.30(a)(2). This regulation does not apply to manufacturers of components or parts of finished devices,but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance.Manufacturers of blood and blood components used for transfusion or for further manufacturing are not subject to this part,but are subject to subchapter F of this chapter.Manufacturers of human cells,tissues,and cellular and tissue-based products(HCT/Ps),as defined in1271.3(d)of this chapter,that are medical devices(subject to premarket review or notification,or exempt from notification,under an application submitted under the device provisions of the act or under a biological product license application under section351of the Public Health Service Act)are subject to this part and are also subject to the donor-eligibility procedures set forth in part1271subpart C of this chapter and applicable current good tissue practice procedures in part1271subpart D of this chapter.In the event of a conflict between applicable regulations in part1271and in other parts of this chapter, the regulation specifically applicable to the device in question shall supersede the more general.(2)The provisions of this part shall be applicable to any finished device as defined in this part,intended for human use, that is manufactured,imported,or offered for import in any State or Territory of the United States,the District of Columbia, or the Commonwealth of Puerto Rico.(3)In this regulation the term"where appropriate"is used several times.When a requirement is qualified by"where appropriate,"it is deemed to be"appropriate"unless the manufacturer can document justification otherwise.A requirement is"appropriate"if nonimplementation could reasonably be expected to result in the product not meeting its specified requirements or the manufacturer not being able to carry out any necessary corrective action.(b)The quality system regulation in this part supplements regulations in other parts of this chapter except where explicitly stated otherwise.In the event of a conflict between applicable regulations in this part and in other parts of this chapter, the regulations specifically applicable to the device in question shall supersede any other generally applicable requirements.(c)Authority.Part820is established and issued under authority of sections501,502,510,513,514,515,518,519,520, 522,701,704,801,803of the act(21U.S.C.351,352,360,360c,360d,360e,360h,360i,360j,360l,371,374,381,383). The failure to comply with any applicable provision in this part renders a device adulterated under section501(h)of the act. Such a device,as well as any person responsible for the failure to comply,is subject to regulatory action.(d)Foreign manufacturers.If a manufacturer who offers devices for import into the United States refuses to permit orallow the completion of a Food and Drug Administration(FDA)inspection of the foreign facility for the purpose of determining compliance with this part,it shall appear for purposes of section801(a)of the act,that the methods used in, and the facilities and controls used for,the design,manufacture,packaging,labeling,storage,installation,or servicing of any devices produced at such facility that are offered for import into the United States do not conform to the requirements of section520(f)of the act and this part and that the devices manufactured at that facility are adulterated under section 501(h)of the act.(e)Exemptions or variances.(1)Any person who wishes to petition for an exemption or variance from any device quality system requirement is subject to the requirements of section520(f)(2)of the act.Petitions for an exemption or variance shall be submitted according to the procedures set forth in10.30of this chapter,the FDA's administrative procedures. Guidance is available from the Food and Drug Administration,Center for Devices and Radiological Health,Division of Small Manufacturers,International and Consumer Assistance,10903New Hampshire Ave.,Bldg.66,rm.4613,Silver Spring,MD 20993-0002,1-800-638-2041or301-796-7100,FAX:301-847-8149.(2)FDA may initiate and grant a variance from any device quality system requirement when the agency determines that such variance is in the best interest of the public health.Such variance will remain in effect only so long as there remains a public health need for the device and the device would not likely be made sufficiently available without the variance.[61FR52654,Oct.7,1996,as amended at65FR17136,Mar.31,2000;65FR66636,Nov.7,2000;69FR29829,May25, 2005;72FR17399,Apr.9,2007;75FR20915,Apr.22,2010;80FR29906,May22,2015]Sec.820.3Definitions.(a)Act means the Federal Food,Drug,and Cosmetic Act,as amended(secs.201-903,52Stat.1040et seq.,as amended(21 U.S.C.321-394)).All definitions in section201of the act shall apply to the regulations in this part.(b)Complaint means any written,electronic,or oral communication that alleges deficiencies related to the identity,quality, durability,reliability,safety,effectiveness,or performance of a device after it is released for distribution.(c)Component means any raw material,substance,piece,part,software,firmware,labeling,or assembly which is intended to be included as part of the finished,packaged,and labeled device.(d)Control number means any distinctive symbols,such as a distinctive combination of letters or numbers,or both,from which the history of the manufacturing,packaging,labeling,and distribution of a unit,lot,or batch of finished devices can be determined.(e)Design history file(DHF)means a compilation of records which describes the design history of a finished device.(f)Design input means the physical and performance requirements of a device that are used as a basis for device design.(g)Design output means the results of a design effort at each design phase and at the end of the total design effort.The finished design output is the basis for the device master record.The total finished design output consists of the device,its packaging and labeling,and the device master record.(h)Design review means a documented,comprehensive,systematic examination of a design to evaluate the adequacy of the design requirements,to evaluate the capability of the design to meet these requirements,and to identify problems. (i)Device history record(DHR)means a compilation of records containing the production history of a finished device. (j)Device master record(DMR)means a compilation of records containing the procedures and specifications for a finisheddevice.(k)Establish means define,document(in writing or electronically),and implement.(l)Finished device means any device or accessory to any device that is suitable for use or capable of functioning,whether or not it is packaged,labeled,or sterilized.(m)Lot or batch means one or more components or finished devices that consist of a single type,model,class,size, composition,or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.(n)Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.(o)Manufacturer means any person who designs,manufactures,fabricates,assembles,or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization,installation, relabeling,remanufacturing,repacking,or specification development,and initial distributors of foreign entities performing these functions.(p)Manufacturing material means any material or substance used in or used to facilitate the manufacturing process,a concomitant constituent,or a byproduct constituent produced during the manufacturing process,which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer.(q)Nonconformity means the nonfulfillment of a specified requirement.(r)Product means components,manufacturing materials,in-process devices,finished devices,and returned devices.(s)Quality means the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance.(t)Quality audit means a systematic,independent examination of a manufacturer's quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures,that these procedures are implemented effectively,and that these procedures are suitable to achieve quality system objectives.(u)Quality policy means the overall intentions and direction of an organization with respect to quality,as established by management with executive responsibility.(v)Quality system means the organizational structure,responsibilities,procedures,processes,and resources for implementing quality management.(w)Remanufacturer means any person who processes,conditions,renovates,repackages,restores,or does any other act to a finished device that significantly changes the finished device's performance or safety specifications,or intended use.(x)Rework means action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution.(y)Specification means any requirement with which a product,process,service,or other activity must conform.(z)Validation means confirmation by examination and provision of objective evidence that the particular requirements fora specific intended use can be consistently fulfilled.(1)Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.(2)Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).(aa)Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.(bb)Human cell,tissue,or cellular or tissue-based product(HCT/P)regulated as a device means an HCT/P as defined in 1271.3(d)of this chapter that does not meet the criteria in1271.10(a)and that is also regulated as a device.(cc)Unique device identifier(UDI)means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of830.20of this chapter.A unique device identifier is composed of:(1)A device identifier--a mandatory,fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device;and(2)A production identifier--a conditional,variable portion of a UDI that identifies one or more of the following when included on the label of the device:(i)The lot or batch within which a device was manufactured;(ii)The serial number of a specific device;(iii)The expiration date of a specific device;(iv)The date a specific device was manufactured.(v)For an HCT/P regulated as a device,the distinct identification code required by1271.290(c)of this chapter.(dd)Universal product code(UPC)means the product identifier used to identify an item sold at retail in the United States. [61FR52654,Oct.7,1996,as amended at78FR58822,Sept.24,2013]Sec.820.5Quality system.Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured,and that meets the requirements of this part.Subpart B--Quality System RequirementsSec.820.20Management responsibility.(a)Quality policy.Management with executive responsibility shall establish its policy and objectives for,and commitment to,quality.Management with executive responsibility shall ensure that the quality policy is understood,implemented,and maintained at all levels of the organization.(b)Organization.Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part.(1)Responsibility and authority.Each manufacturer shall establish the appropriate responsibility,authority,and interrelation of all personnel who manage,perform,and assess work affecting quality,and provide the independence and authority necessary to perform these tasks.(2)Resources.Each manufacturer shall provide adequate resources,including the assignment of trained personnel,for management,performance of work,and assessment activities,including internal quality audits,to meet the requirements of this part.(3)Management representative.Management with executive responsibility shall appoint,and document such appointment of,a member of management who,irrespective of other responsibilities,shall have established authority over and responsibility for:(i)Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part;and(ii)Reporting on the performance of the quality system to management with executive responsibility for review.(c)Management review.Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives.The dates and results of quality system reviews shall be documented.(d)Quality planning.Each manufacturer shall establish a quality plan which defines the quality practices,resources,and activities relevant to devices that are designed and manufactured.The manufacturer shall establish how the requirements for quality will be met.(e)Quality system procedures.Each manufacturer shall establish quality system procedures and instructions.An outline of the structure of the documentation used in the quality system shall be established where appropriate.Sec.820.22Quality audit.Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s),including a reaudit of deficient matters,shall be taken when necessary.A report of the results of each quality audit,and reaudit(s)where taken,shall be made and such reports shall be reviewed by management having responsibility for the matters audited.The dates and results of quality audits and reaudits shall be documented.Sec.820.25Personnel.(a)General.Each manufacturer shall have sufficient personnel with the necessary education,background,training,and experience to assure that all activities required by this part are correctly performed.(b)Training.Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.Training shall be documented.(1)As part of their training,personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.(2)Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.Subpart C--Design ControlsSec.820.30Design controls.(a)General.(1)Each manufacturer of any class III or class II device,and the class I devices listed in paragraph(a)(2)of this section,shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.(2)The following class I devices are subject to design controls:(i)Devices automated with computer software;and(ii)The devices listed in the following chart.Section Device868.6810Catheter,Tracheobronchial Suction.878.4460Glove,Surgeon's.880.6760Restraint,Protective.892.5650System,Applicator,Radionuclide,Manual.892.5740Source,Radionuclide Teletherapy.(b)Design and development planning.Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation.The plans shall identify and describe the interfaces with different groups or activities that provide,or result in,input to the design and development process.The plans shall be reviewed,updated,and approved as design and development evolves.(c)Design input.Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device,including the needs of the user and patient.The procedures shall include a mechanism for addressing incomplete,ambiguous,or conflicting requirements.The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s).The approval,including the date and signature of the individual(s)approving the requirements,shall be documented.(d)Design output.Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements.Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified.Design output shall be documented,reviewed,and approved before release.The approval,including the date and signature of the individual(s)approving the output,shall be documented. (e)Design review.Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development.The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s)who does not have direct responsibility for the design stage being reviewed,as well as any specialists needed.The results of a design review,including identification of the design,the date,and the individual(s)performing the review,shall be documented in the design history file(the DHF).(f)Design verification.Each manufacturer shall establish and maintain procedures for verifying the device design.Design verification shall confirm that the design output meets the design input requirements.The results of the design verification,including identification of the design,method(s),the date,and the individual(s)performing the verification,shall be documented in the DHF.(g)Design validation.Each manufacturer shall establish and maintain procedures for validating the device design.Design validation shall be performed under defined operating conditions on initial production units,lots,or batches,or their equivalents.Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions.Design validation shall include software validation and risk analysis,where appropriate.The results of the design validation,including identification of the design,method(s), the date,and the individual(s)performing the validation,shall be documented in the DHF.(h)Design transfer.Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.(i)Design changes.Each manufacturer shall establish and maintain procedures for the identification,documentation, validation or where appropriate verification,review,and approval of design changes before their implementation.(j)Design history file.Each manufacturer shall establish and maintain a DHF for each type of device.The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.Subpart D--Document ControlsSec.820.40Document controls.Each manufacturer shall establish and maintain procedures to control all documents that are required by this part.The procedures shall provide for the following:(a)Document approval and distribution.Each manufacturer shall designate an individual(s)to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part.The approval,including the date and signature of the individual(s)approving the document,shall be documented.Documents established to meet the requirements of this part shall be available at all locations for which they are designated,used,or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.(b)Document changes.Changes to documents shall be reviewed and approved by an individual(s)in the same function or organization that performed the original review and approval,unless specifically designated otherwise.Approved changes shall be communicated to the appropriate personnel in a timely manner.Each manufacturer shall maintain records of changes to documents.Change records shall include a description of the change,identification of the affected documents, the signature of the approving individual(s),the approval date,and when the change becomes effective.Subpart E--Purchasing ControlsSec.820.50Purchasing controls.Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.(a)Evaluation of suppliers,contractors,and consultants.Each manufacturer shall establish and maintain the requirements, including quality requirements,that must be met by suppliers,contractors,and consultants.Each manufacturer shall: (1)Evaluate and select potential suppliers,contractors,and consultants on the basis of their ability to meet specifiedrequirements,including quality requirements.The evaluation shall be documented.(2)Define the type and extent of control to be exercised over the product,services,suppliers,contractors,and consultants, based on the evaluation results.(3)Establish and maintain records of acceptable suppliers,contractors,and consultants.(b)Purchasing data.Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements,including quality requirements,for purchased or otherwise received product and services.Purchasing documents shall include,where possible,an agreement that the suppliers,contractors,and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device.Purchasing data shall be approved in accordance with820.40.Subpart F--Identification and TraceabilitySec.820.60Identification.Each manufacturer shall establish and maintain procedures for identifying product during all stages of receipt,production, distribution,and installation to prevent mixups.Sec.820.65Traceability.Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit,lot,or batch of finished devices and where appropriate components.The procedures shall facilitate corrective action.Such identification shall be documented in the DHR.Subpart G--Production and Process ControlsSec.820.70Production and process controls.(a)General.Each manufacturer shall develop,conduct,control,and monitor production processes to ensure that a device conforms to its specifications.Where deviations from device specifications could occur as a result of the manufacturing process,the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications.Where process controls are needed they shall include:(1)Documented instructions,standard operating procedures(SOP's),and methods that define and control the manner of production;(2)Monitoring and control of process parameters and component and device characteristics during production;(3)Compliance with specified reference standards or codes;(4)The approval of processes and process equipment;and(5)Criteria for workmanship which shall be expressed in documented standards or by means of identified and approved representative samples.(b)Production and process changes.Each manufacturer shall establish and maintain procedures for changes to a specification,method,process,or procedure.Such changes shall be verified or where appropriate validated according to 820.75,before implementation and these activities shall be documented.Changes shall be approved in accordance with820.40.(c)Environmental control.Where environmental conditions could reasonably be expected to have an adverse effect on product quality,the manufacturer shall establish and maintain procedures to adequately control these environmental conditions.Environmental control system(s)shall be periodically inspected to verify that the system,including necessary equipment,is adequate and functioning properly.These activities shall be documented and reviewed.(d)Personnel.Each manufacturer shall establish and maintain requirements for the health,cleanliness,personal practices, and clothing of personnel if contact between such personnel and product or environment could reasonably be expected to have an adverse effect on product quality.The manufacturer shall ensure that maintenance and other personnel who are required to work temporarily under special environmental conditions are appropriately trained or supervised by a trained individual.(e)Contamination control.Each manufacturer shall establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality.(f)Buildings.Buildings shall be of suitable design and contain sufficient space to perform necessary operations,prevent mixups,and assure orderly handling.(g)Equipment.Each manufacturer shall ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed,constructed,placed,and installed to facilitate maintenance,adjustment, cleaning,and use.(1)Maintenance schedule.Each manufacturer shall establish and maintain schedules for the adjustment,cleaning,and other maintenance of equipment to ensure that manufacturing specifications are met.Maintenance activities,including the date and individual(s)performing the maintenance activities,shall be documented.(2)Inspection.Each manufacturer shall conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules.The inspections,including the date and individual(s) conducting the inspections,shall be documented.(3)Adjustment.Each manufacturer shall ensure that any inherent limitations or allowable tolerances are visibly posted on or near equipment requiring periodic adjustments or are readily available to personnel performing these adjustments. (h)Manufacturing material.Where a manufacturing material could reasonably be expected to have an adverse effect on product quality,the manufacturer shall establish and maintain procedures for the use and removal of such manufacturing material to ensure that it is removed or limited to an amount that does not adversely affect the device's quality.The removal or reduction of such manufacturing material shall be documented.(i)Automated processes.When computers or automated data processing systems are used as part of production or the quality system,the manufacturer shall validate computer software for its intended use according to an established protocol.All software changes shall be validated before approval and issuance.These validation activities and results shall be documented.Sec.820.72Inspection,measuring,and test equipment.(a)Control of inspection,measuring,and test equipment.Each manufacturer shall ensure that all inspection,measuring, and test equipment,including mechanical,automated,or electronic inspection and test equipment,is suitable for its intended purposes and is capable of producing valid results.Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated,inspected,checked,and maintained.The procedures shall include provisions。
21+CFR+820.[中文版本]
![21+CFR+820.[中文版本]](https://img.taocdn.com/s3/m/a64f6cc24028915f804dc273.png)
820部分质量体系法规(QRS)A部分：总条款820.1 范围820.2 定义820.5质量体系B部分：质量体系要求820.20 管理职责820.22质量审核820.25 人员C部分：设计控制820.30设计控制D部分：文件控制820.40 文件控制E部分：采购控制820.50 采购控制F部分：标识和可追溯性820.60 标识820.65 可追溯性G部分：生产和过程控制820.70生产和过程控制820.72检验、测量和实验设备820.75过程确认H部分：接收活动820.80：接收设备准则，过程设备准则，最终设备准则820.86：接收状态I部分：不合格品820.90 不合格品J部分：纠正和预防措施820.100纠正和预防措施K部分：标记和包装控制820.120器械标记820.130器械包装L部分：搬运、储存、销售和安装820.140搬运820.150储存820.160销售820.170安装M部分：记录820.180 总要求820.181 器械主记录820.184 器械的历史记录820.186质量体系记录820.198 抱怨文件N部分：服务820.200 服务O部分：统计技术820.250 统计技术A部分总条款820.1范围（a）适用性。
（1）在本质量体系法规（QSR）中阐述了CGMP的要求。
本部分中的要求规定了在下列情况下使用的方法：所有的预期用于人类的最终器械产品的设计、制造、包装、标记、储存、安装和服务中使用的方法。
本部分的要求可确保最终器械的安全有效，并符合联邦食品、药品和化妆品法案。
本部分内容确定了适用于最终器械的制造商的基本要求。
如果制造商从事的一些操作符合本部分的要求，而不是其他部分的要求，则该制造商只需符合那些用于这些操作上的要求。
对于I类医疗器械，设计控制仅适用于820.3（a）（2）部分列出的那些器械。
本法规不适用于最终器械的组件和部件的制造商，但鼓励这样的制造商使用本法规中的适宜条款做指南。
fda 820 法规
FDA QSR820，也被称为QSR (Quality System Regulation)，是21 CFR 820的一种简易叫法。
这个法规重点关注当前的良好制造工艺（CGMP）和控制，这些控制用于所有拟供人使用的成品设备的设计、包装、标签、存储、安装和维修。
QSR820质量体系规范中描述了现行的生产管理规范的要求。
本规范要求规定了所有医用器械成品在设计、制造、包装、标签、贮存、安装和服务中使用的方法，设施和控制。
这些要求是为了确保医疗器械成品的安全和有效，并遵从美国食品药品和化妆品法。
QSR820提出了适用于医疗器械成品制造商的基本要求，如果某制造商只进行QSR规定的一部分操作，而不进行其他操作，这些制造商应根据实际情况满足QSR中与自己活动相关的条款。
此外，QSR820不适用于医疗器械零件生产商，但FDA鼓励这类企业以QSR820中适用的条款为指导。
同时，QSR820也不适用于人血和血制品生产商，这类企业应遵循21CFR606的规定。
以上内容仅供参考，建议查阅FDA官网获取准确信息。
21CFR 820中文20180401
21CFR 820：201821CFR 820.1 范围(a)适用性(applicability)(1)现行CGMP 要求在质量体系规则中有陈述。
本部分中的要求包括在供人类使用的所有成品器械的设计、生产、包装、标识、存储、安装和维修中使用的方法和被使用的设备和控制。
本部分的要求旨在确保成品器械安全、有效或符合FDCA （法令）。
本部分建立了适用于医疗级产品生产商的基本要求。
如果生产商只用到本部分要求涉及的部分操作且不在其它里面，则生产商只需符合适用于操作的要求即可。
对于I 类产品，设计控制只适用于820.30(a)(2)中列出的那些产品。
本规范不适用于成品器械成分或零部件的生产厂家，但鼓励那些厂家使用本规范的适用规则作为指导。
人类血液或血液成分的生产厂家不需服从本规范，但需服从本章分部分。
人类细胞、组织和以细胞和组织为基础的产品（HCT/Ps ），如本章1271.3（d ）中规定，是医疗器械（涉及售前评审或通知或免除通知，依法令的器械规定提交的申请或依公众健康服务法令351部分的生物产品执照申请），这些产品的制造商受本部分限制，且还要受本章C 分部分1272部分中陈述的捐赠者适配程序和本章C 分部分1272部分中适用的最新良好组织实施程序的限制。
如果本章中1271部分和其它部分有冲突时，专门适用于讨论中的器械应取代另外的常规。
(2)本部分的条款适用于本部分规定的供人类使用的任何产品，此类产品被生产、进口或提供进口美国任何洲或地区、加仑比亚区或波多黎各共同体。
(3)在本规则中术语“如适用”被使用了好几次。
当一种要求被“如适用”修饰时，则它被认为是“适用的”，除非生产商有成文的证明。
如果不能履行会导致产品不能满足规定要求或生产商不能拿出有效的纠正措施，则要求是“适用的”。
(b)局限性(limitations)：除非有特别声明，否则本部分中的质量体系规范是对本章其它部分的补充规则。
如果本章的这一部分和其它部分的适用规范之间有冲突，则专门适用于现有产品的规定应取代任何其它一般适用的要求。
21CFR820中文
美国联邦法规法典第21册第I章健康与人类服务部食品与药品管理局第H小章医疗器械第820部分质量体系法规2014年4月子部分A---总则§820.1范围(a)适用性(1)质量体系法规规定了对现行良好制造法规(CGMP)的要求。
本部分的要求，决定了预期为人类使用的所有成品器械的设计、制造、包装、标记、储存、安装和服务中使用的方法、设施和控制。
本部分的要求意在确保成品器械安全、有效，并且符合联邦食品、药品和化妆品法令。
本部分确定的基本要求适用于成品医疗器械的制造商。
如果制造商仅从事受本法规的要求制约的某些操作，其它操作不受制约，则制造商只须符合适用其操作的要求。
对于I类器械，设计控制只适用于在§820.30(a)(2)中列出的器械。
本法规不适用于为成品器械提供组件或零件的制造商，但鼓励他们将本法规中的适当规定作为指导。
人类血液及血液成分的制造商不受法规本部分的约束，但受本章606部分的约束。
如同本章1271.3(d)所定义的那样，人类细胞、组织、细胞组成的和基于人体组织的产品（HCT /PS)，属于医疗器械产品（遵循上市前评审或通知，或豁免通知，基于一种据法案之器械规定所提交的申请或基于一种符合公卫生服务法案第351节的生物产品许可申请），这些产品遵循本法规且也遵循本章的第1271部分C子部分阐明的捐赠者一合格性程序以及第1271部分D子部分之适用的现行优良组织规范程序。
若发生第1271部分的适用规章与本章的其他部分相矛盾的情况，专门适用于所讨论器械的规章将取代较为一般的规章。
(2)联邦法规法典本部分的规定应适用于由本部分定义的、预期为人类使用的任何成品器械，只要这些器械在在美国任何州或领土、哥伦比亚特区或波多黎哥共同体制造、向其进口或提供向其进口。
(3)本法规多次使用了词组“适当时”。
当一项要求冠以“适当时”，除非制造商能以文件形式提出其它合理理由，它即被认为是“适当的”。
一项要求如果不予实施，即有理由认为预期产品不满足其规定的要求，或者制造商不能采取任何必要的纠正措施，则此种要求是“适当的”。
ISO134852016标准、21CFR820法规与《GMP现场检查指导原则》条款对照表
4.4.5记录的保存期限至少相当于生产企业所规定的医疗器械的寿命期，但从放行产品的日期起不少于2年，或符合相关法规要求，并可追溯。
《质量手册》
《记录控制程序》
ISO13485条款号
21CFR820条款号
组织应至少保存一份作废的受控文件，并确定其保存期限。这个期限应确保至少在组织所规定的医疗器械寿命期内，可以得到此医疗器械的制造和试验的文件，但不要少于记录或相关法规要求所规定的保留期限。
820.40 文件控制
制造商应建立和保持程序以控制所有本部分要求的文件。程序应规定以下内容：
（a）文件的批准和发布：每一个制造商应指定一名人员在文件发布前，评审文件的适宜性和批准文件，以确定满足本部分的要求。文件的批准包括批准的日期和批准人的签名应形成文件。满足本部分要求的文件应在使用现场方便获得，或必要时获得。应迅速从使用现场清除所有的作废文件，以防止非预期的使用。
*4.1.1应当建立健全质量管理体系文件，包括质量方针和质量目标、质量手册、程序文件、技术文件和记录，以及法规要求的其他文件。
《质量手册》
4.1.2组织应：
a考虑组织承担的角色来确定质量管理体系所需的过程在整个组织中的应用
b应用基于风险的方法控制质量管理体系所需的适当过程
c确定这些过程的顺序和相互作用
1.2.2企业负责人应当组织制定质量方针和质量目标。
查看质量方针和质量目标的制定程序、批准人员。
1.2.3企业负责人应当确保质量管理体系有效运行所需的人力资源、基础设施和工作环境。
1.2.4企业负责人应当组织实施管理评审，定期对质量管理体系运行情况进行评估，并持续改进。
美国FDA 21CFR820条文
矯正預防措施
Corrective & Preventive Action
設計管制
生產過程管制
Design Controls
管 理
Production & Process Controls Management
設施設備管制
物料管制
Material Controls
文件紀錄管制
Equipment & Facility Controls
21CFR 820.3 定義(Definitions) (l) 醫療器材成品(Finished device)： 指已適合於使用或發揮功效的醫材或器材配件，無論是否 已經包裝、標示或滅菌。 (m) 批或堆(Lot or batch)： 指由單一種類、機型、等級、尺寸、成分或軟體版本構成， 在相同條件下製造，而且具有相同特性及品質的一個或多 個零件，或醫療器材成品。
21CFR 820.40 文件管制 (b)文件變更。變更文件時，除非另行指定他人，否則應由在 相同部門或組織執行原來審查及核可文件之人審核變更。 應及時的將核准的變更知會適當人員。製造商應紀錄變更 事項，並應在變更紀錄中說明變更內容、被變更之文件、 審核人簽名、核可日期、及變更生效日期。
21CFR 820.180 紀錄管制一般要求 本部分規定之所有記錄均應存放在製造商所在地，或其他製造 商負責幹部及FDA稽察員可以合理取得之處。所有記錄(包括位 放在受檢地點之紀錄)均應準備妥當以供FDA稽察員審閱及影印 。所有記錄均應清晰可讀且適當保存，以使變質情形降至最低 程度並避免遺失。儲存在自動儲存系統內的紀錄應製作備份。
21CFR 820.3 定義(Definitions) (p) 製造原料(Manufacturing material)： 只用於加速製造過程，製造過程中的任何材料或物質，或 在製造過程中產生，並應自醫療器材成品中去除或減少附帶 成分或副產品成分，這些成分屬於製造過程的殘餘雜質， 並非製造商設計或有意保留於醫療器材成品上的物質。 (q) 不符合性(Nonconformity)： 指不符合特定要求之情形。
21CFRPart820-QualitySystemRegulation中文版
21CFRPart820-QualitySystemRegulation中文版第一章—标题21 食品与药物食品与药物管理局健康与人类服务业部门子章节 H 医疗器械第820部品质系统规章子部分A--总则820.1节范围(a)应用性(1)现行优良制造规范（CGMP）的需求在这品质系统规章中被提出。
这部分的需求管控到使用的方法，及用于预期供人类使用之所有成品器械的设计、制造、包装、标示、存贮、安装、及维修服务的设施及控制。
这部分的需求预期用来确保已完成的器械将会安全及有效的且除此外会依循着联邦政府的食品、药品、和化妆品之法案。
这个部分建立合于已完成医疗器械之制造商的基本需求。
如果以这个部分的需求为条件下制造商保证进行最合适的运作，且不管其他，制造商的需要也才会遵守这些合于保证进行运作的需求。
有关等级I的器械，设计管控应用于这些列于820.30(a)(2)的器械。
这个规章不能应用于制造商的零件或是成品器械的部件，但这样的造者是被鼓励于使用这个规章中合适的条款如指导手册。
人类血液及血液成分的制造商不可依循此部分，但依循这章的第606部分。
人类细胞、组织、及细胞组成和组织为基础是属医疗器械部分的产品（HCT/Ps）（定义于这章的1271.3(d)）之制造商，依循这章且也依循提出于这章的第1271部分的子部分之捐赠者-合格性的程序且适用于这章的第1271部分的子部分D的现行优良组织规范程序。
在介于合于第1271部分的规章与这章的其他部分冲突矛盾的事件中，规章在问题中专属合于器械应该取代较为一般的情形。
(2)这部分的条款应合于任何已完成的器械如同这章定义的，预期供人类使用，其可制造、进口、或进口意图在美国的任何州或领土、哥伦比亚地区、或波多黎各共和国。
(3)在这个规章中项目＂哪点适当＂会用到好几次。
当需求具备＂哪点适当＂时，其被认为＂适当的＂除非制造商能提供在其他方面有正当理由的文件。
如果不履行能合理地被预期出未能符合详细说明需求的产品结果或制造商未能实行任何需要的矫正措施，则这个需求是＂适当的＂。
美国FDA 21CFR820条文
21CFR 820.180 紀錄管制一般要求 (a) 保密。若製造商認為紀錄屬於機密文件時，應在紀錄上做 記號，以幫助FDA確定該紀錄是否是本章第20部份有關公 共資訊法規所規定的得公開資料。 (b) 紀錄保存期。本部份規定之紀錄保存期應相當於器材之 設計及預期壽命，但不得少於兩年。(自製造商將產品 上市銷售之日起算)。
21CFR 820.3 定義(Definitions) (l) 醫療器材成品(Finished device)： 指已適合於使用或發揮功效的醫材或器材配件，無論是否 已經包裝、標示或滅菌。 (m) 批或堆(Lot or batch)： 指由單一種類、機型、等級、尺寸、成分或軟體版本構成， 在相同條件下製造，而且具有相同特性及品質的一個或多 個零件，或醫療器材成品。
21CFR 820.20管理責任 (3) 管理代表。負有執行責任之管理階層應指定管理階層之一名 成員(該成員與其他責任無關)，並授與處理下列事項之權責 。製造商應將本項指派與以文件化： (i) 確保依據本部分規定有效地制定及維持品質系統要求。 (ii)將品質系統執行狀況製作成報告，並呈交管理階層審查。
設計管制
生產過程管制
Design Controls
管 理
Production & Process Controls Management
設施設備管制
物料管制
Material Controls
文件紀錄管制
Equipment & Facility Controls
Records,Documents, & Change Controls
21CFR 820.3 定義(Definitions) (r) 產品(Product)： 指零件、原料製造、醫療器材半成品、醫療器材成品及退貨 (s)品質(Quality)： 指決定器材是否適合使用的整體特性，包括器材的安全性及 性能。
21 CFR 820 美国FDA,质量体系(QS)法规医疗器械良好生产规范(中文),2020年5月最新版
标题21-食物和毒品第一章-食品和药物管理局卫生和人类服务部第h章-医疗设备第820部分质量体系监管A部分----一般规定秘书。
820.1范围。
(a)适用性。
（1）本质量体系条例规定了现行良好制造做法要求。
本部分的要求指导所有用于人类使用的成品设备的设计、制造、包装、标签、储存、安装和维修所使用的方法以及所使用的设施和控制。
本部分的要求旨在确保成品设备将是安全和有效的，否则符合联邦食品、药品和化妆品法案（该法案）。
本部分确立了适用于成品医疗器械生产厂家的基本要求..如果制造商只从事符合本部分要求的某些操作，而不是其他操作，则该制造商只需遵守适用于其所从事操作的要求。
关于I类设备，设计控制只适用于820.30(A)（2）中列出的设备。
本条例不适用于部件制造商或成品设备部件制造商，但鼓励这些制造商使用本条例的适当规定作为指导。
用于输血或进一步制造的血液和血液成分的制造商不受本部分的限制，但受本章F节的限制。
本章第1271.3(d)段所界定的人体细胞、组织、细胞和组织产品制造商，即医疗设备（根据该法的设备规定提交的申请或根据《公共卫生服务法》第351节提交的生物产品许可证申请，须接受市场前审查或通知，或免于通知），均须遵守本章第1271节C部分所规定的供者资格程序适用本章第1271节D部分现行良好做法程序。
如果第1271部分和本章其他部分中的适用条例发生冲突，则具体适用于该装置的条例应取代较一般的条例。
（2）本部分的规定适用于在美国任何州或领土、哥伦比亚特区或波多黎各自由邦制造、进口或提供进口的本部分所界定的供人类使用的任何成品装置。
（3）本条例多次使用“酌情”一词。
如果一项要求被“酌情”限定，则被认为是“适当的”，除非制造商可以另有证明。
如果合理地预期不实施会导致产品不符合其规定的要求或制造商无法采取任何必要的纠正行动，则要求是“适当的”。
(b)本部分的质量体系条例补充了本章其他部分的规定，但另有明确说明的除外。
美国FDA《联邦规章典集》（CFR）第21篇目录（中英文）
美国FDA《联邦规章典集》（CFR）第21篇目录（中英文）美国FDA《联邦规章典集》（CFR）第21篇目录中文版概述：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 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）2 100-1693 170-1994 200-2995 300-4996 500-5997 600-7998 800-12999 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 AD MINISTRATION, 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 REGULATIONS2 一般行政规则与决定GENERAL ADMINISTRATIVE RULINGS AND DECISIONS3 产品管辖权PRODUCT JURISDICTION5 组织ORGANIZATION7 强制执行政策ENFORCEMENT POLICY10 行政规范与程序ADMINISTRATIVE PRACTICES AND PROCEDURES11 电子化记录；电子化签名ELECTRONIC RECORDS; ELECTRONIC SIGNATURES12 正式证据的公众听证FORMAL EVIDENTIARY PUBLIC HEARING13 在公众质询委员会前的公众听证PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY14 在公众咨询委员会前的公众听证PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE15 在FDA局长前的公众听证PUBLIC HEARING BEFORE THE COMMISSIONER16 在FDA前的规制性听证REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION17 行政罚款听证CIVIL MONEY PENALTIES HEARINGS19 行为标准与利益冲突STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST20 公共信息PUBLIC INFORMATION21 隐私保护PROTECTION OF PRIVACY25 环境影响考虑ENVIRONMENTAL IMPACT CONSIDERATIONS26 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 COMMUNITY50 人类受试者的保护PROTECTION OF HUMAN SUBJECTS54 临床试验者的财务公开FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS56 机构审查委员会INSTITUTIONAL REVIEW BOARDS58 对非临床实验室研究的良好实验室规范GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES60 专利期恢复PATENT TERM RESTORATION70 色素添加剂COLOR ADDITIVES71 色素添加剂申请COLOR ADDITIVE PETITIONS73 免除认证的色素添加剂的列表LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION74 适用认证的色素添加剂的列表LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION80 色素添加剂认证COLOR ADDITIVE CERTIFICATION81 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 COSMETICS82 经认证的临时性列表的色素和规范的列表LISTING OFCERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS83-98 [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GENERAL101 食品标识FOOD LABELING102 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 PROCEDURES107 婴儿配方母乳替代食品INFANT FORMULA108 紧急许可控制EMERGENCY PERMIT CONTROL109 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 MATERIAL110 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 INMANUFACTURING, 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 CONTAINERS114 酸化食品ACIDIFIED FOODS115 带壳蛋SHELL EGGS119 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 RISK120 危害分析与关键控制点（HACCP）体系HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS123 鱼与渔业产品FISH AND FISHERY PRODUCTS129 饮用水加工与装瓶PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER130 食品标准：总则FOOD STANDARDS: GENERAL131 乳与奶油MILK AND CREAM133 乳酪与相关乳酪产品CHEESES AND RELATED CHEESE PRODUCTS135 冷冻点心FROZEN DESSERTS136 烘焙产品BAKERY PRODUCTS137 谷物粉与相关产品CEREAL FLOURS AND RELATED PRODUCTS139 通心粉与面条产品MACARONI AND NOODLE PRODUCTS 145 罐装水果CANNED FRUITS146 罐装水果汁CANNED FRUIT JUICES150 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 PIES155 罐装蔬菜CANNED VEGETABLES156 蔬菜汁VEGETABLE JUICES158 冷冻蔬菜FROZEN VEGETABLES160 蛋与蛋制品EGGS AND EGG PRODUCTS161 鱼与有壳的水生动物FISH AND SHELLFISH163 可可制品CACAO PRODUCTS164 树坚果与花生制品TREE NUT AND PEANUT PRODUCTS165 饮料BEVERAGES166 人造黄油MARGARINE168 增甜剂与餐桌糖浆SWEETENERS AND TABLE SIRUPS169 食品敷料与调味料FOOD DRESSINGS AND FLAVORINGS 170 食品添加剂FOOD ADDITIVES171 食品添加剂申请FOOD ADDITIVE PETITIONS172 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 CONSUMPTION173 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 CONSUMPTION174 间接食品添加剂：总则INDIRECT FOOD ADDITIVES: GENERAL175 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 SANITIZERS179 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 STUDY181 先前核准的食品配料PRIOR-SANCTIONED FOOD INGREDIENTS182 一般认为安全的物质SUBSTANCES GENERALLYRECOGNIZED AS SAFE184 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 FOOD190 膳食补充剂DIETARY SUPPLEMENTS191-199 [预留的] [Reserved]第C分章―药品：总则（SUBCHAPTER C―DRUGS: GENERAL）200 总则GENERAL201 标识LABELING202 处方药广告PRESCRIPTION DRUG ADVERTISING203 处方药销售PRESCRIPTION DRUG MARKETING205 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 DISTRIBUTORS206 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 DISTRIBUTION208 处方药的药物治疗指导MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS210 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; GENERAL211 对完成的药品的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHEDPHARMACEUTICALS216 药房配药PHARMACY COMPOUNDING225 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 DRUGS290 管制的药品CONTROLLED DRUGS299 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GENERAL310 新药NEW DRUGS312 试验用新药申请INVESTIGATIONAL NEW DRUG APPLICATION314 为FDA批准上市新药的申请APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG315 诊断用放射性药品DIAGNOSTIC RADIOPHARMACEUTICALS316 罕见病药ORPHAN DRUGS320 生物利用度与生物等效性要求BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS328 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 ALCOHOL330 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 NOTMISBRANDED331 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 USE333 用于非处方的人类使用的局部抗菌药品TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOROVER-THE-COUNTER HUMAN USE335 用于非处方的人类使用的止泻药品ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE336 用于非处方的人类使用的止吐药品ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE338 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 FOROVER-THE-COUNTER HUMAN USE340 用于非处方的人类使用的兴奋药品STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE341 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 USE343 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 USE347 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 USE348 用于非处方的人类使用的外部的止痛药品EXTERNAL ANALGESIC DRUG PRODUCTS FOROVER-THE-COUNTER HUMAN USE349 用于非处方的人类使用的眼科药品OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE350 用于非处方的人类使用的止汗药品ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE352 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 USE357 用于非处方的人类使用的其他内服药品MISCELLANEOUS INTERNAL DRUG PRODUCTS FOROVER-THE-COUNTER HUMAN USE358 用于非处方的人类使用的其他外用药品MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOROVER-THE-COUNTER HUMAN USE361 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 RESEARCH369 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 SALE370-499 [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GENERAL501 动物食品标识ANIMAL FOOD LABELING502 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 MATERIAL510 新动物药NEW ANIMAL DRUGS511 作为试验用途的新动物药NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE514 新动物药申请NEW ANIMAL DRUG APPLICATIONS515 含药饲料厂执照MEDICATED FEED MILL LICENSE520 口服剂型的新动物药ORAL DOSAGE FORM NEW ANIMAL DRUGS522 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 DRUGS526 乳房内的剂型INTRAMAMMARY DOSAGE FORMS529 某些其他剂型的新动物药CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS530 在动物中的特别标签药品使用EXTRALABEL DRUG USE IN ANIMALS556 在食品中新动物药残留的容许量TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD558 用于动物饲料的新动物药NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS564 [预留的] [Reserved]570 食品添加剂FOOD ADDITIVES571 食品添加剂申请FOOD ADDITIVE PETITIONS573 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 ANIMALS579 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 FOOD582 一般认为安全的物质SUBSTANCES GENERALLY RECOGNIZED AS SAFE584 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 ANIMALS589 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（SUBCH APTER F―BIOLOGICS）600 生物制品：总则BIOLOGICAL PRODUCTS: GENERAL601 颁发执照LICENSING606 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 COMPONENTS607 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 STANDARDS630 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 DERIVATIVES640 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 FORLABORATORY TESTS680 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GENERAL701 化妆品标识COSMETIC LABELING710 化妆品机构的自愿登记VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS720 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 STATEMENTS741-799 [预留的] [Reserved]第H分章―医疗器械（SUBCHAPTER H―MEDICAL DEVICES）800 总则GENERAL801 标识LABELING803 医疗器械报告MEDICAL DEVICE REPORTING806 医疗器械；改正与移动的报告MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS807 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 REQUIREMENTS809 人用体外诊断产品IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE810 医疗器械召回权MEDICAL DEVICE RECALL AUTHORITY812 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 OFMEDICAL DEVICES820 质量体系规章QUALITY SYSTEM REGULATION821 医疗器械跟踪要求MEDICAL DEVICE TRACKING REQUIREMENTS822 上市后监视POSTMARKET SURVEILLANCE860 医疗器械分类程序MEDICAL DEVICE CLASSIFICATION PROCEDURES861 性能标准制定程序PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT862 临床化学与临床毒理学器械CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES864 血液学与病理学器械HEMATOLOGY AND PATHOLOGY DEVICES866 免疫学与微生物学器械IMMUNOLOGY AND MICROBIOLOGY DEVICES868 麻醉学器械ANESTHESIOLOGY DEVICES870 心血管器械CARDIOVASCULAR DEVICES872 牙科器械DENTAL DEVICES874 耳、鼻和咽器械EAR, NOSE, AND THROAT DEVICES876 胃肠病学-泌尿学器械GASTROENTEROLOGY-UROLOGY DEVICES878 普通与整形外科器械GENERAL AND PLASTIC SURGERY DEVICES880 普通医院与个人使用器械GENERAL HOSPITAL AND PERSONAL USE DEVICES882 神经学器械NEUROLOGICAL DEVICES884 产科与妇科学器械OBSTETRICAL AND GYNECOLOGICAL DEVICES886 眼科器械OPHTHALMIC DEVICES888 矫形外科器械ORTHOPEDIC DEVICES890 内科学器械PHYSICAL MEDICINE DEVICES892 放射学器械RADIOLOGY DEVICES895 禁止的器械BANNED DEVICES898 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GENERAL1002 记录与报告RECORDS AND REPORTS1003 缺陷与未能守法的通报NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY1004 电子产品的回购、修理或者置换REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS1005 电子产品的进口IMPORTATION OF ELECTRONIC PRODUCTS1010 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 PRODUCTS1030 微波与射电频率发生产品的性能标准PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS1040 发光产品的性能标准PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS1050 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 ACT1230 根据《联邦腐蚀性毒物法》的规章REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT1240 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 TRANSPLANTATION1271 人体细胞、组织以及细胞的和基于组织的产品HUMAN CELLS, TISSUES, AND CELLULAR ANDTISSUE-BASED PRODUCTS1272-1299 [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DEFINITIONS1301 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 SUBSTANCES1302 对管制物质的标识与包装要求LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES 1303 定额QUOTAS1304 登记者的记录与报告RECORDS AND REPORTS OF REGISTRANTS1305 令的格式ORDER FORMS1306 处方PRESCRIPTIONS1307 杂项MISCELLANEOUS1308 管制物质的表SCHEDULES OF CONTROLLED SUBSTANCES1309 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 CHEMICALS1310 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 SUBSTANCES1313 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 INFORMATION1402 强制性解密审查MANDATORY DECLASSIFICATION REVIEW1403 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 GOVERNMENTS1404 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]。