# 21 CFR § 315.3: General factors relevant to safety and effectiveness

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-315.3

## Section

- **Citation:** 21 CFR § 315.3
- **Heading:** General factors relevant to safety and effectiveness
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE > PART 315—DIAGNOSTIC RADIOPHARMACEUTICALS

## Text

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.

## Nearby sections

- [21 CFR § 315.1 § 315.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-315.1.md)
- [21 CFR § 315.2 § 315.2 Definition.](https://www.frixlaw.com/law-library/statutes/ecfr-21-315.2.md)
- [21 CFR § 315.3 § 315.3 General factors relevant to safety and effectiveness.](https://www.frixlaw.com/law-library/statutes/ecfr-21-315.3.md)
- [21 CFR § 315.4 § 315.4 Indications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-315.4.md)
- [21 CFR § 315.5 § 315.5 Evaluation of effectiveness.](https://www.frixlaw.com/law-library/statutes/ecfr-21-315.5.md)
- [21 CFR § 315.6 § 315.6 Evaluation of safety.](https://www.frixlaw.com/law-library/statutes/ecfr-21-315.6.md)
- [21 CFR § 317.2 § 317.2 List of qualifying pathogens that have the potential to pose a serious threat to public health.](https://www.frixlaw.com/law-library/statutes/ecfr-21-317.2.md)
- [21 CFR § 329.100 § 329.100 Postmarketing reporting of adverse drug events under section 760 of the Federal Food, Drug, and Cosmetic Act.](https://www.frixlaw.com/law-library/statutes/ecfr-21-329.100.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-315.3. Check the current official text before relying on it. Not legal advice.