{"data":{"id":"us/21-cfr-1003.2","jurisdiction":"us","citation":"21 CFR 1003.2","heading":"Defect in an electronic product.","body":"For the purpose of this part, an electronic product shall be considered to have a defect which relates to the safety of use by reason of the emission of electronic product radiation if:\n(a) It is a product which does not utilize the emission of electronic product radiation in order to accomplish its purpose, and from which such emissions are unintended, and as a result of its design, production or assembly;\n(1) It emits electronic product radiation which creates a risk of injury, including genetic injury, to any person, or\n(2) It fails to conform to its design specifications relating to electronic radiation emissions; or\n(b) It is a product which utilizes electronic product radiation to accomplish its primary purpose and from which such emissions are intended, and as a result of its design, production or assembly it;\n(1) Fails to conform to its design specifications relating to the emission of electronic product radiation; or\n(2) Without regard to the design specifications of the product, emits electronic product radiation unnecessary to the accomplishment of its primary purpose which creates a risk of injury, including genetic injury to any person; or\n(3) Fails to accomplish the intended purpose.","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 A—General Provisions"],"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":"d2e1ff05c9b74322e0ba2c7bc025f029f209cf7849dd032231464e13d03f2571","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-1003.1","next":"us/21-cfr-1003.5"},"notice":"GroundRules: Original legal text. Not legal advice."}