Quality system. Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part. Subpart B—Quality System Requirements
21 CFR Part 820 · Quality Management System Regulation
§ 820.5 § 820.5 [Reserved]
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Warning letters citing § 820.5
2 FDA warning letters since 2017 cite this section :
- Chirp Innovations, LLC 2 Oct 2026
- LEVO AG 18 Jul 2025
FDA guidance that cites § 820.5
- Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry 1 Dec 2011
- Medical Glove Guidance Manual: Guidance for Industry and FDA Staff 22 Jan 2008
- Shelf Life of Medical Devices 1 Apr 1991
Amendment history
Federal Register documents that created or amended this section.
- 89 FR 7523 2 Feb 2024