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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 April 1 2020.

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]
[Revised as of April 1, 2020]
[CITE: 21CFR860.120]
See Related Information on General. 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 C - Reclassification

Sec. 860.120 General.

(a) Sections 513(e) and (f), 514(b), 515(b), and 520(l) of the 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]

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