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发帖数: 25265 | 1 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsear
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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. |
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