{"data":{"id":"us/21-cfr-601.31","jurisdiction":"us","citation":"21 CFR 601.31","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 F—BIOLOGICS","PART 601—LICENSING","Subpart D—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":"020dbe38e950ca32c214b66ec3b7ad4e6b16e48a4dd2b48612eb28ed7114168b","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-601.30","next":"us/21-cfr-601.32"},"notice":"GroundRules: Original legal text. Not legal advice."}