# 21 CFR § 812.10: Waivers

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-812.10

## Section

- **Citation:** 21 CFR § 812.10
- **Heading:** Waivers
- **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) Request. A sponsor may request FDA to waive any requirement of this part. A waiver request, with supporting documentation, may be submitted separately or as part of an application to the address in § 812.19.
(b) FDA action. FDA may by letter grant a waiver of any requirement that FDA finds is not required by the act and is unnecessary to protect the rights, safety, or welfare of human subjects.
(c) Effect of request. Any requirement shall continue to apply unless and until FDA waives it.

## 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-21-812.10. Check the current official text before relying on it. Not legal advice.