{"data":{"id":"us/21-cfr-315.2","jurisdiction":"us","citation":"21 CFR 315.2","heading":"Definition.","body":"For purposes of this part, diagnostic radiopharmaceutical means:\n(a) An article that is intended for use in the diagnosis or monitoring of a disease or a manifestation of a disease in humans and that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons; or\n(b) Any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of such article as defined in paragraph (a) of this section.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER D—DRUGS FOR HUMAN USE","PART 315—DIAGNOSTIC RADIOPHARMACEUTICALS"],"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":"8b0454c079f745470f2bc650c282312db3ddf9277ada1d8573f523df4a1cfd5a","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-315.1","next":"us/21-cfr-315.3"},"notice":"GroundRules: Original legal text. Not legal advice."}