21 CFR § 860.200 - Purpose and applicability.

---
identifier: "/us/cfr/t21/s860.200"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 860.200 - Purpose and applicability."
title_number: 21
title_name: "Food and Drugs"
section_number: "860.200"
section_name: "Purpose and applicability."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "860"
part_name: "MEDICAL DEVICE CLASSIFICATION PROCEDURES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321(h), 353(g), 360c, 360d, 360e, 360i, 360j, 371, 374."
regulatory_source: "43 FR 32993, July 28, 1978, unless otherwise noted."
cfr_part: "860"
---


# 860.200 Purpose and applicability.

(a) The purpose of this part is to establish an efficient, transparent, and thorough process to facilitate De Novo classification into class I or class II for devices for which there is no legally marketed device on which to base a review of substantial equivalence and which meet the definition of class I or class II as described in section 513(a)(1) of the Federal Food, Drug, and Cosmetic Act and § 860.3.

(b) De Novo requests can be submitted for a single device type:

(1) After receiving a not substantially equivalent determination in response to a premarket notification (510(k)), or

(2) If a person determines there is no legally marketed device upon which to base a determination of substantial equivalence.