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21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371, 374.
38 FR 28625, Oct. 15, 1973, unless otherwise noted.
60 FR 48386, Sept. 19, 1995, unless otherwise noted.
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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.