LegalFix
Sign In

§ 601.33 - Indications.

Copy with citation
Copy as parenthetical citation

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.

Previous Section
§ 601.32 - General factors relevant to safety and effectiveness.
Next Section
§ 601.34 - Evaluation of effectiveness.