美国FDA-21CFR820法规(详细)英文版.pdf

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 § 820.30 - 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 process 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--Corrective 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 - Installation. 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. Authority: 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)Applicab