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1、SUBCHAPTER H-MEDICAL DEVICES PART 820 QUALITY SYSTEM REGULATION Subpart A-General Provisions 820.1 - Scope. 820.3 - Definitions. 820.5 - Quality system. Subpart B-Quality System Requirements 820.20 - Management responsibility. 820.22 - Quality audit. 820.25 - Personnel. Subpart C-Design Controls 820
2、.30 - Design controls. Subpart D-Document Controls 820.40 - Document controls. Subpart E-Purchasing Controls 820.50 - Purchasing controls. Subpart F-Identification and Traceability 820.60 - Identification. 820.65 - Traceability. Subpart G-Production and Process Controls 820.70 - Production and proce
3、ss controls. 820.72 - Inspection, measuring, and test equipment. 820.75 - Process validation. Subpart H-Acceptance Activities 820.80 - Receiving, in-process, and finished device acceptance. 820.86 - Acceptance status. Subpart I-Nonconforming Product 820.90 - Nonconforming product. Subpart J-Correcti
4、ve and Preventive Action 820.100 - Corrective and preventive action. Subpart K-Labeling and Packaging Control 820.120 - Device labeling. 820.130 - Device packaging. Subpart L-Handling, Storage, Distribution, and Installation 820.140 - Handling. 820.150 - Storage. 820.160 - Distribution. 820.170 - In
5、stallation. Subpart M-Records 820.180 - General requirements. 820.181 - Device master record. 820.184 - Device history record. 820.186 - Quality system record. 820.198 - Complaint files. Subpart N-Servicing 820.200 - Servicing. Subpart O-Statistical Techniques 820.250 - Statistical techniques. Autho
6、rity: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264. Source: 61 FR 52654, Oct. 7, 1996, unless otherwise noted. Subpart A-General Provisions Sec. 820.1 Scope. (a)Applicability. (1) Current good manufacturing practice (CGMP) requi
7、rements 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 requirem
8、ents 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 i
9、n 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). Thi
10、s 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
11、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 provision
12、s 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
13、 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 t
14、o 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
15、 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
16、 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 specifical
