21 CFR § 1002.11 - Supplemental reports.

---
identifier: "/us/cfr/t21/s1002.11"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1002.11 - Supplemental reports."
title_number: 21
title_name: "Food and Drugs"
section_number: "1002.11"
section_name: "Supplemental reports."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "J"
subchapter_name: "RADIOLOGICAL HEALTH"
part_number: "1002"
part_name: "RECORDS AND REPORTS"
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. 352, 360, 360i, 360j, 360hh-360ss, 371, 374."
regulatory_source: "38 FR 28625, Oct. 15, 1973, unless otherwise noted."
cfr_part: "1002"
---


# 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 for which a report under § 1002.10 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.