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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Nov 29, 2022.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR860.210]
See Related Information on De Novo request format. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H - MEDICAL DEVICES

PART 860 -- MEDICAL DEVICE CLASSIFICATION PROCEDURES

Subpart D - De Novo Classification

Sec. 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.

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