美国FDA 820规法规.doc

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)Applicability. (1) Current