Quality System Regulation (QSR)

CGMP for Medical Devices

21 Code of Federal Regulations (CFR) PART 820

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.

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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.

Download 21 CFR Part 820 in PDF

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Last Updated: 2015-08-17