CFR›Title 21›Chapter I›Part 315 ContainsSections 315.1–315.6CorpusDaily eCFRDisplayed edition2026-04-15Last updated2026-04-15 PART 315—DIAGNOSTIC RADIOPHARMACEUTICALS Sections 315.1 § 315.1 Scope. 315.2 § 315.2 Definition. 315.3 § 315.3 General factors relevant to safety and effectiveness. 315.4 § 315.4 Indications. 315.5 § 315.5 Evaluation of effectiveness. 315.6 § 315.6 Evaluation of safety. Authority21 U.S.C. 321, 331, 351, 352, 353, 355, 371, 374, 379e; sec. 122, Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note).Source64 FR 26667, May 17, 1999, unless otherwise noted. Previous 314 Part 314—Applications for FDA Approval to Market a New Drug Next 316 Part 316—Orphan Drugs