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e-CFR data is current as of September 17, 2020

Title 21Chapter ISubchapter FPart 601Subpart D → §601.33


Title 21: Food and Drugs
PART 601—LICENSING
Subpart D—Diagnostic Radiopharmaceuticals


§601.33   Indications.

(a) For diagnostic radiopharmaceuticals, the categories of proposed indications for use include, but are not limited to, the following:

(1) Structure delineation;

(2) Functional, physiological, or biochemical assessment;

(3) Disease or pathology detection or assessment; and

(4) Diagnostic or therapeutic patient management.

(b) 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.

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