Title 21: Food and Drugs
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/ PART 1002 - RECORDS AND REPORTS
/ Subpart B - Required Manufacturers' Reports for Listed Electronic Products / § 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.