# Immunology and Microbiology Devices; Reclassification of Nucleic Acid-Based Test Systems for Use with a Corresponding Approved Oncology Therapeutic Product

> **FDA** · Rulemaking · Modified 2026-01-28T17:58:22Z

## Docket
- **Docket ID:** FDA-2025-N-4622
- **Agency:** FDA
- **Type:** Rulemaking
- **Last modified:** 2026-01-28T17:58:22Z

## Source
- [regulations.gov docket](https://www.regulations.gov/docket/FDA-2025-N-4622)
- [Public comments](https://www.regulations.gov/docket/FDA-2025-N-4622/comments)

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