21 CFR § 20.113 - Voluntary product defect reports.

---
identifier: "/us/cfr/t21/s20.113"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 20.113 - Voluntary product defect reports."
title_number: 21
title_name: "Food and Drugs"
section_number: "20.113"
section_name: "Voluntary product defect reports."
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"
---


# 20.113 Voluntary product defect reports.

Voluntary reports of defects in products subject to the jurisdiction of the Food and Drug Administration are available for public disclosure:

(a) If the report is submitted by the manufacturer, after deletion of data and information falling within the exemptions established in § 20.61 for trade secrets and confidential commercial or financial information and in § 20.63 for personal privacy.

(b) If the report is submitted by any person other than the manufacturer, after deletion of names and other information that would identify the person submitting the report and any data or information falling within the exemption established in § 20.63 for personal privacy.