§ 315.1 - Scope.
§ 315.2 - Definition.
§ 315.3 - General factors relevant to safety and effectiveness.
§ 315.4 - Indications.
§ 315.5 - Evaluation of effectiveness.
§ 315.6 - Evaluation of safety.
Authority: 21 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). Source: 64 FR 26667, May 17, 1999, unless otherwise noted.