# 21 CFR § 860.120: General

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-860.120

## Section

- **Citation:** 21 CFR § 860.120
- **Heading:** General
- **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 860—MEDICAL DEVICE CLASSIFICATION PROCEDURES > Subpart C—Reclassification

## Text

(a) Sections 513(e) and (f), 514(b), 515(b), and 520(l) of the Federal Food, Drug, and Cosmetic Act provide for reclassification of a device and prescribe the procedures to be followed to effect reclassification. The purposes of subpart C are to:
(1) Set forth the requirements as to form and content of petitions for reclassification;
(2) Describe the circumstances in which each of the five statutory reclassification provisions applies; and
(3) Explain the procedure for reclassification prescribed in the five statutory reclassification provisions.
(b) The criteria for determining the proper class for a device are set forth in § 860.3(c). The reclassification of any device within a generic type of device causes the reclassification of all devices within that generic type. Accordingly, a petition for the reclassification of a specific device will be considered a petition for reclassification of all devices within the same generic type.
(c) Any interested person may submit a petition for reclassification under section 513(e), 514(b), or 515(b) of the Federal Food, Drug, and Cosmetic Act. A manufacturer or importer may submit a petition for reclassification under section 513(f) or 520(l) of the Federal Food, Drug, and Cosmetic Act. The Commissioner may initiate the reclassification of a device under the following sections of the Federal Food, Drug, and Cosmetic Act:
(1) Section 513(e) (for a classified device other than a device classified into class III under section 513(f)(1) or 520(l)(1) of the Federal Food, Drug, and Cosmetic Act);
(2) Section 513(f)(3) (for a device classified into class III under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act); or
(3) Section 520(l)(2) (for a device classified into class III under section 520(l)(1) of the Federal Food, Drug, and Cosmetic Act).
[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992; 83 FR 64456, Dec. 17, 2018]

## Nearby sections

- [21 CFR § 860.1 § 860.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.1.md)
- [21 CFR § 860.3 § 860.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.3.md)
- [21 CFR § 860.5 § 860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.5.md)
- [21 CFR § 860.7 § 860.7 Determination of safety and effectiveness.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.7.md)
- [21 CFR § 860.10 § 860.10 Implants and life-supporting or life-sustaining devices.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.10.md)
- [21 CFR § 860.15 § 860.15 Exemptions from sections 510, 519, and 520(f) of the Federal Food, Drug, and Cosmetic Act.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.15.md)
- [21 CFR § 860.84 § 860.84 Classification procedures for “preamendments devices.”](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.84.md)
- [21 CFR § 860.90 § 860.90 Consultation with panels.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.90.md)
- [21 CFR § 860.120 § 860.120 General.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.120.md)
- [21 CFR § 860.123 § 860.123 Reclassification petition: Content and form.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.123.md)
- [21 CFR § 860.125 § 860.125 Consultation with panels.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.125.md)
- [21 CFR § 860.130 § 860.130 General procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.130.md)
- [21 CFR § 860.132 § 860.132 Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the Federal Food, Drug, and Cosmetic Act.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.132.md)
- [21 CFR § 860.133 § 860.133 Procedures when the Commissioner initiates a proceeding to require premarket approval under section 515(b) of the Federal Food, Drug, and Cosmetic Act.](https://www.frixlaw.com/law-library/statutes/ecfr-21-860.133.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-860.120. Check the current official text before relying on it. Not legal advice.