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) > 1002.11—Supplemental reports.

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 § 1002.1 for which a report under § 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.