# 21 CFR § 315.2: Definition

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-315.2

## Section

- **Citation:** 21 CFR § 315.2
- **Heading:** Definition
- **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

Link to an amendment published at 91 FR 60004, Sept. 22, 2026.
For purposes of this part, diagnostic radiopharmaceutical means:
(a) An article that is intended for use in the diagnosis or monitoring of a disease or a manifestation of a disease in humans and that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons; or
(b) Any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of such article as defined in paragraph (a) of this section.

## 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-21-315.2. Check the current official text before relying on it. Not legal advice.