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21 CFR § 1.1395 - Under what circumstances may FDA revise or revoke modified requirements or an exemption?

---
identifier: "/us/cfr/t21/s1.1395"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1.1395 - Under what circumstances may FDA revise or revoke modified requirements or an exemption?"
title_number: 21
title_name: "Food and Drugs"
section_number: "1.1395"
section_name: "Under what circumstances may FDA revise or revoke modified requirements or an exemption?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "1"
part_name: "GENERAL ENFORCEMENT REGULATIONS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 350d, 350j, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374, 381, 382, 384a, 387, 387a, 387c, 393, and 2223; 42 U.S.C. 216, 241, 243, 262, 264, 271."
regulatory_source: "42 FR 15553, Mar. 22, 1977, unless otherwise noted."
cfr_part: "1"
---

# 1.1395 Under what circumstances may FDA revise or revoke modified requirements or an exemption?

FDA may revise or revoke modified requirements or an exemption if we determine that such revision or revocation is necessary to protect the public health.