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Code · CFR · Title 21 — Food and Drugs · Part 1002 — Records and Reports · § 1002.11

§ 1002.11. Supplemental reports.

93 words·~1 min read·/us/cfr/t21/s§ 1002.11·

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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.
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