---
kind: "section"
citation: "21 C.F.R. § 1002.11"
title: "21"
number: "1002.11"
heading: "Supplemental reports."
url: "https://uscodex.org/cfr/21/1002.11"
---

# §1002.11. Supplemental reports.


Prior to the introduction into commerce of a new or modified model within a model or chassis family of a product listed in table 1 of [§ 1002.1](/cfr/21/1002.1.md) for which a report under [§ 1002.10](/cfr/21/1002.10.md) is required, each manufacturer shall submit a report with respect to such new or modified model describing any changes in the information previously submitted in the product report. Reports will be required for changes that:

- (a) **Affect actual or potential radiation emission.**
- (b) **Affect the manner of compliance with a standard or manner of testing for radiation safety.**

## Notes

### Source

Source: 60 FR 48386, Sept. 19, 1995, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371, 374.

### Source

Source: 38 FR 28625, Oct. 15, 1973, unless otherwise noted.