{"data":{"id":"us/21-cfr-315.4","jurisdiction":"us","citation":"21 CFR 315.4","heading":"Indications.","body":"(a) For diagnostic radiopharmaceuticals, the categories of proposed indications for use include, but are not limited to, the following:\n(1) Structure delineation;\n(2) Functional, physiological, or biochemical assessment;\n(3) Disease or pathology detection or assessment; and\n(4) Diagnostic or therapeutic patient management.\n(b) Where a diagnostic radiopharmaceutical is not intended to provide disease-specific information, the proposed indications for use may refer to a biochemical, physiological, anatomical, or pathological process or to more than one disease or condition.","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":"92e4578b4679124212482540335200dd12879b6aac6bb35a5d12b2d6217449b9","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-315.3","next":"us/21-cfr-315.5"},"notice":"GroundRules: Original legal text. Not legal advice."}