§601.33. Indications.
21 C.F.R. § 601.33
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
Source
Source: 64 FR 26668, May 17, 1999, unless otherwise noted.
Authority
Authority: 15 U.S.C. 1451-1561; 21 U.S.C. 321, 351, 352, 353, 355, 356b, 360, 360c-360f, 360h-360j, 371, 374, 379e, 381; 42 U.S.C. 216, 241, 262, 263, 264; sec 122, Pub. L. 105-115, 111 Stat. 2322 (21 U.S.C. 355 note), sec 7002(e), Pub. L. 111-148, 124 Stat. 817, as amended by sec. 607, Division N, Pub. L. 116-94, 133 Stat. 3127.
Source
Source: 38 FR 32052, Nov. 20, 1973, unless otherwise noted.