Small business rule changes · compliance updates · daily

The Small Business
Rule Change Brief

Vol. 1 · No. 1118

Friday, October 9, 2026

1118 issues in archive

Rule lifecycle · RIN:0910-AJ27

Nonclinical Testing Terminology

Health and Human Services Department, Food and Drug Administration — observed across 2 documents over 0 days. Use the source documents below before deciding whether this affects your business.

In plain English

The FDA is updating the words and definitions used for the safety tests that drugmakers and device manufacturers must perform on products before testing them with human patients. Small business owners in pharmaceuticals and medical devices should prepare to use these new standard terms when writing safety reports and submitting applications to the FDA.

First seen

Sep 22, 2026

Last seen

Sep 22, 2026

Latest stage

Proposed Rule

PRORULE → RULE

0d

Comments close

Monday, December 7, 2026

Stage timeline

  1. Final·Sep 22, 2026·91 FR 59988

    Nonclinical Testing Terminology

    effective Feb 4, 2027comments close Dec 7, 2026#2026-19350

  2. Proposed·Sep 22, 2026·91 FR 60036

    Nonclinical Testing Terminology

    comments close Dec 7, 2026#2026-19349