21 CFR § 20.116 - Drug and device registration and listing information.

---
identifier: "/us/cfr/t21/s20.116"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 20.116 - Drug and device registration and listing information."
title_number: 21
title_name: "Food and Drugs"
section_number: "20.116"
section_name: "Drug and device registration and listing information."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "20"
part_name: "PUBLIC INFORMATION"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21 U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1."
regulatory_source: "42 FR 15616, Mar. 22, 1977, unless otherwise noted."
cfr_part: "20"
---


# 20.116 Drug and device registration and listing information.

Information submitted to the Food and Drug Administration pursuant to section 510(a) through (j) of the Federal Food, Drug, and Cosmetic Act shall be subject only to the special disclosure provisions established in §§ 207.81 and 807.37 of this chapter.

[81 FR 60212, Aug. 31, 2016]