Code of Federal Regulations Title 21. Food and Drugs § 21.860.130 General procedures under section 513(e) of the Federal Food, Drug, and Cosmetic Act

(1) On the initiative of the Commissioner alone;

(2) On the initiative of the Commissioner in response to a request for change in classification based upon new information, under section 514(b) or 515(b) of the act (see § 860.132);  or

(3) In response to the petition of an interested person, based upon new information, filed in accordance with § 860.123.

(1) Class I or class II to class III if the Commissioner determines that the device meets the criteria set forth in § 860.3(c)(3) for a class III device;  or

(2) Class III or class I to class II if the Commissioner determines that the device meets the criteria set forth in § 860.3(c)(2) for a class II device;  or

(3) Class III or class II to class I if the Commissioner determines that the device meets the criteria set forth in § 860.3(c)(1) for a class I device.

(d)(1) The Commissioner shall consult with a classification panel and may secure a recommendation with respect to reclassification of a device from a classification panel. The panel will consider reclassification in accordance with the consultation procedures of § 860.125. A recommendation submitted to the Commissioner by the panel will be published in the Federal Register when the Commissioner publishes an administrative order under this section.

(2) The Commissioner may change the classification of a device by administrative order published in the Federal Register following publication of a proposed reclassification order in the Federal Register, a meeting of a device classification panel described in section 513(b) of the Federal Food, Drug, and Cosmetic Act, and consideration of comments to a public docket.