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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 820QUALITY 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.

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