# Nonclinical Testing Terminology

**Action Urgency Score:** 45/100

| Field | Value |
|---|---|
| Agency | Health and Human Services Department; Food and Drug Administration |
| Type | Final rule |
| Action | Direct final rule. |
| Published | 2026-09-22 |
| Effective | 2027-02-04 |
| Comments close | 2026-12-07 |
| Significant | No |
| CFR parts | 21 CFR 312, 21 CFR 314, 21 CFR 315, 21 CFR 361, 21 CFR 601 |
| Summary | The Food and Drug Administration (FDA, Agency, or we) is issuing a direct final rule that substitutes references to "animal" tests or studies with "nonclinical" tests or studies, adds a definition of the terms "nonclinical test" and "nonclinical study," and makes other comparable or conforming amendments in certain safety and reporting sections of its regulations. The direct final rule also substitutes "nonclinical" for "preclinical" and "in vitro" for consistency in terminology. The Agency is issuing these amendments directly as a final rule because we believe they are noncontroversial change |
| Document number | 2026-19350 |

## Why this score
- Upcoming deadline.
- Final rule.

Source: Federal Register API (Office of the Federal Register) (https://www.federalregister.gov/documents/2026/09/22/2026-19350/nonclinical-testing-terminology). Last refreshed: 2026-11-04T21:40:49.974Z.
Data from the Federal Register API; the published Federal Register document is authoritative. Informational only, not legal advice.