{"data":{"id":"us/21-cfr-1003.20","jurisdiction":"us","citation":"21 CFR 1003.20","heading":"Notification by the manufacturer to the Secretary.","body":"The notification to the Secretary required by § 1003.10(a) shall be confirmed in writing and, in addition to other relevant information which the Secretary may require, shall include the following:\n(a) Identification of the product or products involved;\n(b) The total number of such product units so produced, and the approximate number of such product units which have left the place of manufacture;\n(c) The expected usage for the product if known to the manufacturer;\n(d) A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard;\n(e) An evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard;\n(f) A statement of the measures to be taken to repair such defect or to bring the product into compliance with the Federal standard;\n(g) The date and circumstances under which the defect was discovered; and\n(h) The identification of any trade secret information which the manufacturer desires kept confidential.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER J—RADIOLOGICAL HEALTH","PART 1003—NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY","Subpart C—Notification"],"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":"d95049e10d15868e68f2ae0492fa2623899fabc7ac43efd3e9b01ec2c194ed3f","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-1003.11","next":"us/21-cfr-1003.21"},"notice":"GroundRules: Original legal text. Not legal advice."}