---
kind: "section"
citation: "21 C.F.R. § 860.210"
title: "21"
number: "860.210"
heading: "De Novo request format."
url: "https://uscodex.org/cfr/21/860.210"
---

# §860.210. De Novo request format.

- (a) Each De Novo request or information related to a De Novo request pursuant to this part must be formatted in accordance with this section. Each De Novo request must be provided as a single version in electronic format. These materials must:
  - (1)
    - (i) For devices regulated by the Center for Devices and Radiological Health, be sent to the current address displayed on the website https://www.fda.gov/cdrhsubmissionaddress.
    - (ii) For devices regulated by the Center for Biologics Evaluation and Research, be sent to the current address displayed on the website https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/regulatory-submissions-electronic-and-paper.
  - (2) **Be signed by the requester or an authorized representative.**
  - (3) **Be designated “De Novo Request” in the cover letter.**
  - (4) **Have all content used to support the request written in, or translated into, English.**

## Notes

### Source

Source: 86 FR 54847, Oct. 5, 2021, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 321(h), 353(g), 360c, 360d, 360e, 360i, 360j, 371, 374.

### Source

Source: 43 FR 32993, July 28, 1978, unless otherwise noted.