[Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2002] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR1002.12] [Page 573] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 1002--RECORDS AND REPORTS--Table of Contents Subpart B--Required Manufacturers' Reports for Listed Electronic Products Sec. 1002.12 Abbreviated reports. Manufacturers of products requiring abbreviated reports as specified in table 1 of Sec. 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.