What FDA Quality Management System Regulation (QMSR) - 21 CFR Part 820 incorporating ISO 13485:2016, with 2025 Technical Amendments requires
21 CFR Part 820, the Quality Management System Regulation (QMSR), sets out current good manufacturing practice (CGMP) requirements and requires manufacturers to document a quality management system that complies with the applicable requirements of ISO 13485 (incorporated by reference, see section 820.7) and other applicable requirements of this part; manufacturers engaged in the design, manufacture, packaging, labeling, storage, installation, or servicing of a finished device must establish and maintain a quality management system appropriate for their specific devices.
Pillar: Medical & Healthcare · Authority: US Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/part-820
SHA-256 integrity: 369ec1550ea1782b8b5582bc485d306708a0d1181ca4b4b40983323ec3423520
Primary Citations — 6 traced to source
- 21 CFR Part 820 - Quality Management System Regulation (US Food and Drug Administration)
- Section 820.1 Scope: Current good manufacturing practice (CGMP) requirements are set forth in this quality management system regulation (QMSR).
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