Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 20  /  Sec. 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 Sec. 20.61 for trade secrets and confidential commercial or financial information and in Sec. 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 Sec. 20.63 for personal privacy.