# Medical Devices; Quality Management System Regulation Technical Amendments

> **FDA** · Rulemaking · Modified 2025-12-04T15:51:36Z

## Docket
- **Docket ID:** FDA-2025-N-4635
- **Agency:** FDA
- **Type:** Rulemaking
- **Last modified:** 2025-12-04T15:51:36Z

## Source
- [regulations.gov docket](https://www.regulations.gov/docket/FDA-2025-N-4635)
- [Public comments](https://www.regulations.gov/docket/FDA-2025-N-4635/comments)

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