21 CFR 20.113
§ 20.113 Voluntary product defect reports.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 20.113, § 20.113 Voluntary product defect reports, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83368
- Permanent ID
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.