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(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]
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