21 CFR § 809.4 - Confidentiality of submitted information.

---
identifier: "/us/cfr/t21/s809.4"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 809.4 - Confidentiality of submitted information."
title_number: 21
title_name: "Food and Drugs"
section_number: "809.4"
section_name: "Confidentiality of submitted information."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "809"
part_name: "IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321(h)(1), 331, 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 371, 372, 374, 381, and 42 U.S.C. 262."
cfr_part: "809"
---


# 809.4 Confidentiality of submitted information.

Data and information submitted under § 809.10(c) that are shown to fall within the exemption established in § 20.61 of this chapter shall be treated as confidential by the Food and Drug Administration and any person to whom the data and information are referred. The Food and Drug Administration will determine whether information submitted will be treated as confidential in accordance with the provisions of part 20 of this chapter.

[45 FR 7484, Feb. 1, 1980]