# 21 CFR § 807.34: Summary of requirements for owners or operators granted a waiver from submitting required information electronically

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-807.34

## Section

- **Citation:** 21 CFR § 807.34
- **Heading:** Summary of requirements for owners or operators granted a waiver from submitting required information electronically
- **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 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES > Subpart B—Procedures for Device Establishments

## Text

(a) For initial registration and listing, owners or operators who have been granted a waiver from electronic filing using the procedures set forth in § 807.21(b) must send a letter containing all of the registration and listing information described in §§ 807.22, 807.25 (and § 807.26 when such information is requested by FDA), at the times described in § 807.22, to: The Imports and Registration and Listing Team, Division of Regulatory Programs 2, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1432, Silver Spring, MD 20993-0002.
(b) As specified in § 807.22(b)(1) and (b)(3), all owners or operators shall update their establishment registration and device listings annually during the period beginning on October 1 and ending on December 31 of each fiscal year.
(c) Failure to submit any of the required information on time, as specified in § 807.22(a) and (b), will put the establishment in a “failed to register” or “failed to list” status as applicable.
The establishment will not be considered active and the establishment registration and device listing information may not appear on the FDA Web site until the required information is submitted to and processed by FDA.
[77 FR 45943, Aug. 2, 2012, as amended at 85 FR 18442, Apr. 2, 2020]

## Nearby sections

- [21 CFR § 807.3 § 807.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-807.3.md)
- [21 CFR § 807.20 § 807.20 Who must register and submit a device list?](https://www.frixlaw.com/law-library/statutes/ecfr-21-807.20.md)
- [21 CFR § 807.21 § 807.21 How to register establishments and list devices.](https://www.frixlaw.com/law-library/statutes/ecfr-21-807.21.md)
- [21 CFR § 807.22 § 807.22 Times for establishment registration and device listing.](https://www.frixlaw.com/law-library/statutes/ecfr-21-807.22.md)
- [21 CFR § 807.25 § 807.25 Information required for device establishment registration and device listing.](https://www.frixlaw.com/law-library/statutes/ecfr-21-807.25.md)
- [21 CFR § 807.26 § 807.26 Additional listing information.](https://www.frixlaw.com/law-library/statutes/ecfr-21-807.26.md)
- [21 CFR § 807.28 § 807.28 Updating device listing information.](https://www.frixlaw.com/law-library/statutes/ecfr-21-807.28.md)
- [21 CFR § 807.34 § 807.34 Summary of requirements for owners or operators granted a waiver from submitting required information electronically.](https://www.frixlaw.com/law-library/statutes/ecfr-21-807.34.md)
- [21 CFR § 807.35 § 807.35 Notification of registrant.](https://www.frixlaw.com/law-library/statutes/ecfr-21-807.35.md)
- [21 CFR § 807.37 § 807.37 Public availability of establishment registration and device listing information.](https://www.frixlaw.com/law-library/statutes/ecfr-21-807.37.md)
- [21 CFR § 807.39 § 807.39 Misbranding by reference to establishment registration or to registration number.](https://www.frixlaw.com/law-library/statutes/ecfr-21-807.39.md)
- [21 CFR § 807.40 § 807.40 Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States.](https://www.frixlaw.com/law-library/statutes/ecfr-21-807.40.md)
- [21 CFR § 807.41 § 807.41 Identification of importers and persons who import or offer for import.](https://www.frixlaw.com/law-library/statutes/ecfr-21-807.41.md)
- [21 CFR § 807.65 § 807.65 Exemptions for device establishments.](https://www.frixlaw.com/law-library/statutes/ecfr-21-807.65.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-807.34. Check the current official text before relying on it. Not legal advice.