---
kind: "section"
citation: "21 C.F.R. § 1003.20"
title: "21"
number: "1003.20"
heading: "Notification by the manufacturer to the Secretary."
url: "https://uscodex.org/cfr/21/1003.20"
---

# §1003.20. Notification by the manufacturer to the Secretary.


The notification to the Secretary required by [§ 1003.10(a)](/cfr/21/1003.10.md?p=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.**

## Notes

### Authority

Authority: 21 U.S.C. 360hh-360ss.

### Source

Source: 38 FR 28628, Oct. 15, 1973, unless otherwise noted.