21 CFR § 1003.20 - Notification by the manufacturer to the Secretary.

---
identifier: "/us/cfr/t21/s1003.20"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1003.20 - Notification by the manufacturer to the Secretary."
title_number: 21
title_name: "Food and Drugs"
section_number: "1003.20"
section_name: "Notification by the manufacturer to the Secretary."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "J"
subchapter_name: "RADIOLOGICAL HEALTH"
part_number: "1003"
part_name: "NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY"
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. 360hh-360ss."
regulatory_source: "38 FR 28628, Oct. 15, 1973, unless otherwise noted."
cfr_part: "1003"
---


# 1003.20 Notification by the manufacturer to the Secretary.

The notification to the Secretary required by § 1003.10(a) shall be confirmed in writing and, in addition to other relevant information which the Secretary may require, shall include the following:

(a) Identification of the product or products involved;

(b) The total number of such product units so produced, and the approximate number of such product units which have left the place of manufacture;

(c) The expected usage for the product if known to the manufacturer;

(d) A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard;

(e) An evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard;

(f) A statement of the measures to be taken to repair such defect or to bring the product into compliance with the Federal standard;

(g) The date and circumstances under which the defect was discovered; and

(h) The identification of any trade secret information which the manufacturer desires kept confidential.