[Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR1002.11] [Page 582] 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. 1002.11 Supplemental reports. Prior to the introduction into commerce of a new or modified model within a model or chassis family of a product listed in table 1 of Sec. 1002.1 for which a report under Sec. 1002.10 is required, each manufacturer shall submit a report with respect to such new or modified model describing any changes in the information previously submitted in the product report. Reports will be required for changes that: (a) Affect actual or potential radiation emission. (b) Affect the manner of compliance with a standard or manner of testing for radiation safety.