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:

Set forth the requirements as to form and content of petitions for reclassification;

Describe the circumstances in which each of the five statutory reclassification provisions applies; and

Explain the procedure for reclassification prescribed in the five statutory reclassification provisions.

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.

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:

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);

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

Section 520(l)(2) (for a device classified into class III under section 520(l)(1) of the Federal Food, Drug, and Cosmetic Act).