# 21 CFR § 807.35: Notification of registrant

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-807.35

## Section

- **Citation:** 21 CFR § 807.35
- **Heading:** Notification of registrant
- **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) The Food and Drug Administration will assign each device establishment a registration number after verifying the initial establishment registration information that has been submitted. The owner or operator of the establishment will also be assigned an identifying number. Both numbers will be sent to the official correspondent by email, or by postal mail if the owner or operator has been granted a waiver from the requirement to file registration and listing information electronically.
(b) Owners or operators of device establishments who also manufacture or process biological products (including devices licensed under section 351 of the Public Health Service Act) or drug products at the same establishment must also register and list those products under part 607 or part 207 of this chapter, as appropriate. Registration and listing for human blood and blood products, devices licensed under section 351 of the Public Health Service Act, and licensed biological products used in the manufacture of a device licensed under section 351 of the Public Health Service Act, are subject to part 607 of this chapter; registration and listing for all other drug products (including other biological products that are also regulated as drug products) are subject to part 207 of this chapter.
(c) Although establishment registration and device listing are required to engage in the device activities described in § 807.20, validation of registration and the assignment of a device listing number in itself does not establish that the holder of the registration is legally qualified to deal in such devices and does not represent a determination by the Food and Drug Administration as to the status of any device.
[69 FR 11312, Mar. 10, 2004, as amended at 77 FR 45943, Aug. 2, 2012]

## 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-21-807.35. Check the current official text before relying on it. Not legal advice.