21 CFR § 1002.12 - Abbreviated reports.

---
identifier: "/us/cfr/t21/s1002.12"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1002.12 - Abbreviated reports."
title_number: 21
title_name: "Food and Drugs"
section_number: "1002.12"
section_name: "Abbreviated 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"
---


# 1002.12 Abbreviated reports.

Manufacturers of products requiring abbreviated reports as specified in table 1 of § 1002.1 shall submit, prior to the introduction of such product, a report distinctly marked “Radiation Safety Abbreviated Report” which shall include:

(a) Firm and model identification.

(b) A brief description of operational characteristics that affect radiation emissions, transmission, or leakage or that control exposure.

(c) A list of applications or uses.

(d) Radiation emission, transmission, or leakage levels.

(e) If necessary, additional information as may be requested to determine compliance with the Act and this part.