21CFR820 Quality System Regulation.docx

1、21CFR 820 Quality System RegulationTITLE 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 practi

2、ce (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 us

3、e. 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 manufac

4、turer 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 82

5、0.30(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

6、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 d

7、evice 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 prac

8、tice 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 b

9、e 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

10、 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 re

11、quirements 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

12、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

13、, 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

14、 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

15、 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 i

16、mport 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 petition for an exemption or varianc

17、e 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 Fo

18、od 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

19、 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 sufficientl

20、y 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 (s

21、ecs. 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 related to the identity, quality, durability, reliabi

22、lity, 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 numbe

23、r 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 re

24、cords 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. T

25、he 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 th

26、e 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 con

27、taining the procedures and specifications for a finished device.(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,

28、 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 spe

29、cified 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, assembles, or pr

30、ocesses 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)Manufacturi

31、ng 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

32、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 sa

33、tisfy fitness-for-use, 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 activi