{"data":{"id":"us/21-cfr-1002.11","jurisdiction":"us","citation":"21 CFR 1002.11","heading":"Supplemental reports.","body":"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:\n(a) Affect actual or potential radiation emission.\n(b) Affect the manner of compliance with a standard or manner of testing for radiation safety.","path":["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"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"68ce0f7243b11ea1861b2d2379266425da4d4a4d32c7feca391132c54d856a78","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-1002.10","next":"us/21-cfr-1002.12"},"notice":"GroundRules: Original legal text. Not legal advice."}
