# 21 CFR § 812.7: Prohibition of promotion and other practices

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-812.7

## Section

- **Citation:** 21 CFR § 812.7
- **Heading:** Prohibition of promotion and other practices
- **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 H—MEDICAL DEVICES > PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS > Subpart A—General Provisions

## Text

A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not:
(a) Promote or test market an investigational device, until after FDA has approved the device for commercial distribution.
(b) Commercialize an investigational device by charging the subjects or investigators for a device a price larger than that necessary to recover costs of manufacture, research, development, and handling.
(c) Unduly prolong an investigation. If data developed by the investigation indicate in the case of a class III device that premarket approval cannot be justified or in the case of a class II device that it will not comply with an applicable performance standard or an amendment to that standard, the sponsor shall promptly terminate the investigation.
(d) Represent that an investigational device is safe or effective for the purposes for which it is being investigated.

## Nearby sections

- [21 CFR § 812.1 § 812.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.1.md)
- [21 CFR § 812.2 § 812.2 Applicability.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.2.md)
- [21 CFR § 812.3 § 812.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.3.md)
- [21 CFR § 812.5 § 812.5 Labeling of investigational devices.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.5.md)
- [21 CFR § 812.7 § 812.7 Prohibition of promotion and other practices.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.7.md)
- [21 CFR § 812.10 § 812.10 Waivers.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.10.md)
- [21 CFR § 812.18 § 812.18 Import and export requirements.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.18.md)
- [21 CFR § 812.19 § 812.19 Address for IDE correspondence.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.19.md)
- [21 CFR § 812.20 § 812.20 Application.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.20.md)
- [21 CFR § 812.25 § 812.25 Investigational plan.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.25.md)
- [21 CFR § 812.27 § 812.27 Report of prior investigations.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.27.md)
- [21 CFR § 812.28 § 812.28 Acceptance of data from clinical investigations conducted outside the United States.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.28.md)
- [21 CFR § 812.30 § 812.30 FDA action on applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.30.md)
- [21 CFR § 812.35 § 812.35 Supplemental applications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-812.35.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-812.7. Check the current official text before relying on it. Not legal advice.