Regulations last checked for updates: Oct 18, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024
§ 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.

authority: 21 U.S.C. 352,360,360i,360j,360hh-360ss,371,374
source: 38 FR 28625, Oct. 15, 1973, unless otherwise noted.
cite as: 21 CFR 1002.11