§315.4. Indications.
21 C.F.R. § 315.4
For diagnostic radiopharmaceuticals, the categories of proposed indications for use include, but are not limited to, the following:
Structure delineation;
Functional, physiological, or biochemical assessment;
Disease or pathology detection or assessment; and
Diagnostic or therapeutic patient management.
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.
Notes, amendments, and revision history
Authority
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
Source: 64 FR 26667, May 17, 1999, unless otherwise noted.