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§1002.11. Supplemental reports.

21 C.F.R. § 1002.11

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.
Notes, amendments, and revision history

Source

Source: 60 FR 48386, Sept. 19, 1995, unless otherwise noted.

Authority

Authority: 21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371, 374.

Source

Source: 38 FR 28625, Oct. 15, 1973, unless otherwise noted.