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e-CFR data is current as of August 13, 2020

Title 21Chapter ISubchapter JPart 1002Subpart B → §1002.12


Title 21: Food and Drugs
PART 1002—RECORDS AND REPORTS
Subpart B—Required Manufacturers' Reports for Listed Electronic Products


§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.

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