# 21 CFR § 812.19: Address for IDE correspondence

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-812.19

## Section

- **Citation:** 21 CFR § 812.19
- **Heading:** Address for IDE correspondence
- **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) If you are sending an application, supplemental application, report, request for waiver, request for import or export approval, or other correspondence relating to matters covered by this part, you must send the submission to the appropriate address as follows:
(1) For devices regulated by the Center for Devices and Radiological Health, send it to the current address displayed on the website https://www.fda.gov/cdrhsubmissionaddress.
(2) For devices regulated by the Center for Biologics Evaluation and Research, send it to the current address displayed on the website https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm385240.htm.
(3) For devices regulated by the Center for Drug Evaluation and Research, send it to Central Document Control Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266.
(b) You must state on the outside wrapper of each submission what the submission is, for example, an “IDE application,” a “supplemental IDE application,” or a “correspondence concerning an IDE (or an IDE application).”
[71 FR 42048, July 25, 2006, as amended at 75 FR 20915, Apr. 22, 2010; 80 FR 18094, Apr. 3, 2015; 84 FR 68339, Dec. 16, 2019]

## 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-21-812.19. Check the current official text before relying on it. Not legal advice.