GroundRules
21 CFR 1002.11: Supplemental reports.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER J—RADIOLOGICAL HEALTH
- PART 1002—RECORDS AND REPORTS
- Subpart B—Required Manufacturers' Reports for Listed Electronic Products
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON