---
kind: "section"
citation: "21 C.F.R. § 315.3"
title: "21"
number: "315.3"
heading: "General factors relevant to safety and effectiveness."
url: "https://uscodex.org/cfr/21/315.3"
---

# §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
- (c) **The estimated absorbed radiation dose of the diagnostic radiopharmaceutical.**

## Notes

### 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.