21CFR - 820 Quality System Regulation

TITLE 21-FOOD AND DRUGSCHAPTER I-FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H-MEDICAL DEVICES PART 820 QUALITY SYSTEM REGULATIONSubpart A-General Provisions Sec. 820.1 Scope.(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 in 820.30(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 human blood and blood components are not subject to this part, but are subject to part 606 of this chapter. Manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in 1271.3(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 section 351 of the Public Health Service Act) are subject to this part and are also subject to the donor-eligibility procedures set forth in part 1271 subpart C of this chapter and applicable current good tissue practice procedures in part 1271 subpart D of this chapter. In the event of a conflict between applicable regulations in part 1271 and 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正当理由 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) scope. 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. Part 820 is established and issued under authority of sections 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803 of the act (21 U.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 section 501(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 or allow 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 section 801(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 section 520(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 petitionpt()n for an exemption or variance from any device quality system requirement is subject to the requirements of section 520(f)(2) of the act. Petitions for an exemption or variance shall be submitted according to the procedures set forth in 10.30 of this chapter, the FDAs 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, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002, 1-800-638-2041 or 301-796-7100, 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.61 FR 52654, Oct. 7, 1996, as amended at 65 FR 17136, Mar. 31, 2000; 65 FR 66636, Nov. 7, 2000; 69 FR 29829, May 25, 2005; 72 FR 17399, Apr. 9, 2007; 75 FR 20915, Apr. 22, 2010Sec. 820.3 Definitions.(a)Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-903, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-394). All definitions in section 201 of the act shall apply to the regulations in this part.(b)Complaint means any written, electronic, or oral communication that alleges deficiencies缺陷 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原材料, substance, piece, part, software, firmware固件, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.(d)Control number译？ 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器械主记录？. The total finished design output consists of the device, its packaging and labeling, and the device master record.(h)Design review设计评审 means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements设计要求, to evaluate the capability of the design to meet these requirements, and to identify problems.(i)Device history record (DHR )历史记录 means a compilation of records containing the production history of a finished device生产记录.(j)Device master record (DMR ) means a compilation of records containing the procedures程序 and specifications规范 for a finished device.(k)Establish means define, document (in writing or electronically), and implement.(l)Finished device means any device or accessory配件 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模型, class, size, composition组成/组合, 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 manufacturers quality policy and quality system.(o)Manufacturer means any person who designs, manufactures, fabricates制造, 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 entti个体/实体 performing these functions.(p)Manufacturing material means any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent伴随成分, or a byproduct constituent副产品成分 produced during the manufacturing process, which is present in or on the finished device as a residue rezdu剩余物 or impurity杂志 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成品, 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适用性, including safety and performance.(t)Quality audit means a systematic, independent examination of a manufacturers 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质量手册 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再生商译？ means any person who processes, conditions, renovates ren.vet修复, repackages, restores, or does any other act to a finished device that significantly changes the finished devices performance or safety specifications, or intended use.(x)Rework返工 means action taken on a nonconforming product不合格品 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验证 means confirmation by examination and provision of objective evidence客观证据 that the particular requirements for a specific intended use预期用途 can be consistently fulfilled.(1)Process validation过程检验 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使用需求 and intended use(s).(aa)Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.Sec. 820.5 Quality 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. 820.20 Management 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, implementedmpl.ment, 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评估 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不顾 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定义区间 and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturers 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. 820.22 Quality 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)纠正措施, 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. 820.25 Personnel. (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 defect缺陷s 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. 820.30 Design 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.SectionDevice868.6810Catheter, Tracheobronchial Suction.878.4460Glove, Surgeons.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更新.(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 mek.nzm机理方法 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一致性 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 devices 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