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Electronic Code of Federal Regulations

e-CFR data is current as of December 3, 2019

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.
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Subpart B—QUALITY SYSTEM REQUIREMENTS

§820.20
Management responsibility.
§820.22
Quality audit.
§820.25
Personnel.
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Subpart C—DESIGN CONTROLS

§820.30
Design controls.
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Subpart D—DOCUMENT CONTROLS

§820.40
Document controls.
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Subpart E—PURCHASING CONTROLS

§820.50
Purchasing controls.
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Subpart F—IDENTIFICATION AND TRACEABILITY

§820.60
Identification.
§820.65
Traceability.
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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.
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Subpart I—NONCONFORMING PRODUCT

§820.90
Nonconforming product.
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Subpart J—CORRECTIVE AND PREVENTIVE ACTION

§820.100
Corrective and preventive action.
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Subpart K—LABELING AND PACKAGING CONTROL

§820.120
Device labeling.
§820.130
Device packaging.
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Subpart L—HANDLING, STORAGE, DISTRIBUTION, AND INSTALLATION

§820.140
Handling.
§820.150
Storage.
§820.160
Distribution.
§820.170
Installation.
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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.
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Subpart O—STATISTICAL TECHNIQUES

§820.250
Statistical techniques.

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