21 C.F.R. § 1002.11 Supplemental reports.
Title 21 - Food and Drugs
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.
Title 21: Food and Drugs
PART 1002—RECORDS AND REPORTS
Subpart B—Required Manufacturers' Reports for Listed Electronic Products
§ 1002.11 Supplemental reports.
