21 CFR §860.210

1. (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. (1)
      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.
      2. (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. (2)Be signed by the requester or an authorized representative.
   3. (3)Be designated “De Novo Request” in the cover letter.
   4. (4)Have all content used to support the request written in, or translated into, English.