21 CFR § 1002.12 Records and Reports

§ 1002.12 Abbreviated reports.

Current through Sep 8, 2026 · Read all of Part 1002

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.

← § 1002.11 Supplemental reports.§ 1002.13 Annual reports. →