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

---
identifier: "/us/cfr/t21/s315.3"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 315.3 - General factors relevant to safety and effectiveness."
title_number: 21
title_name: "Food and Drugs"
section_number: "315.3"
section_name: "General factors relevant to safety and effectiveness."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "315"
part_name: "DIAGNOSTIC RADIOPHARMACEUTICALS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
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)."
regulatory_source: "64 FR 26667, May 17, 1999, unless otherwise noted."
cfr_part: "315"
---


# 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.