CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER J—RADIOLOGICAL HEALTH (parts 1000 to 1050) > PART 1002—RECORDS AND REPORTS > SUBPART B—Required Manufacturers' Reports for Listed Electronic Products (§1002.10 to §1002.13) > 1002.12—Abbreviated reports.

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.