eCFR Reference Browser

---

title: "21 CFR §809.4"

source: "https://www.ecfr.gov/current/title-21/section-809.4"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "809"

part_subject: "IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE"

subpart_code: "A"

subpart_subject: "General Provisions"

section_number: "809.4"

section_subject: "Confidentiality of submitted information."

cfr_reference: "21 CFR 809.4"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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.

§809.4 - Confidentiality of submitted information.