21 CFR 315.3 - General factors relevant to safety and effectiveness.

Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024

View all text of Part 315 [§ 315.1 - § 315.6]

§ 315.3 - General factors relevant to safety and effectiveness.

FDA's determination of the safety and effectiveness of a diagnostic radiopharmaceutical includes consideration of the following:

(a) The proposed use of the diagnostic radiopharmaceutical in the practice of medicine,

(b) The pharmacological and toxicological activity of the diagnostic radiopharmaceutical (including any carrier or ligand component of the diagnostic radiopharmaceutical), and

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.

cite as: 21 CFR 315.3