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Electronic Code of Federal Regulations

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e-CFR Data is current as of September 19, 2014

Title 21Chapter ISubchapter HPart 820


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H—MEDICAL DEVICES

PART 820—QUALITY SYSTEM REGULATION

rule

Subpart A—GENERAL PROVISIONS

§820.1
Scope.
§820.3
Definitions.
§820.5
Quality system.
rule

Subpart B—QUALITY SYSTEM REQUIREMENTS

§820.20
Management responsibility.
§820.22
Quality audit.
§820.25
Personnel.
rule

Subpart C—DESIGN CONTROLS

§820.30
Design controls.
rule

Subpart D—DOCUMENT CONTROLS

§820.40
Document controls.
rule

Subpart E—PURCHASING CONTROLS

§820.50
Purchasing controls.
rule

Subpart F—IDENTIFICATION AND TRACEABILITY

§820.60
Identification.
§820.65
Traceability.
rule

Subpart G—PRODUCTION AND PROCESS CONTROLS

§820.70
Production and process controls.
§820.72
Inspection, measuring, and test equipment.
§820.75
Process validation.
rule

Subpart H—ACCEPTANCE ACTIVITIES

§820.80
Receiving, in-process, and finished device acceptance.
§820.86
Acceptance status.
rule

Subpart I—NONCONFORMING PRODUCT

§820.90
Nonconforming product.
rule

Subpart J—CORRECTIVE AND PREVENTIVE ACTION

§820.100
Corrective and preventive action.
rule

Subpart K—LABELING AND PACKAGING CONTROL

§820.120
Device labeling.
§820.130
Device packaging.
rule

Subpart L—HANDLING, STORAGE, DISTRIBUTION, AND INSTALLATION

§820.140
Handling.
§820.150
Storage.
§820.160
Distribution.
§820.170
Installation.
rule

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.
rule

Subpart N—SERVICING

§820.200
Servicing.
rule

Subpart O—STATISTICAL TECHNIQUES

§820.250
Statistical techniques.


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