21 CFR Part 820
PART 820—QUALITY MANAGEMENT SYSTEM REGULATION
- PART 820—QUALITY MANAGEMENT SYSTEM REGULATION
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter H—Medical Devices
- Subpart A—General Provisions
- § 820.1 Scope.
- § 820.3 Definitions.
- § 820.5 [Reserved]
- § 820.7 Incorporation by reference.
- § 820.10 Requirements for a quality management system.
- Subpart B—Supplemental Provisions
- §§ 820.20-820.30 [Reserved]
- § 820.35 Control of records.
- § 820.40 [Reserved]
- § 820.45 Device labeling and packaging controls.
- Subparts C-O [Reserved]
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