Electronic Code of Federal Regulations
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e-CFR data is current as of August 13, 2020 |
Title 21 → Chapter I → Subchapter J → Part 1002 → Subpart 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.