§ 860.123 - Reclassification petition: Content and form.

§ 860.123 Reclassification petition: Content and form.

(a) Unless otherwise provided in writing by the Commissioner, any petition for reclassification of a device, regardless of the section of the act Federal Food, Drug, and Cosmetic Act under which it is filed, shall include the following:

(1) A specification of the type of device for which reclassification is requested;

(2) A statement of the action requested by the petitioner, e.g., “It is requested that _ device(s) be reclassified from class III to a class II”;

(3) A statement of the basis for disagreement with the present classification status of the device;

(4) A full statement of the reasons, together with supporting data satisfying the requirements of § 860.7, why the device should not be classified into its present classification and how the proposed classification will provide reasonable assurance of the safety and effectiveness of the device;

(5) Representative data and information known by the petitioner that are unfavorable to the petitioner's position;

(6) If the petition is based upon new information under section 513(e), 514(b), or 515(b) of the act, Federal Food, Drug, and Cosmetic Act, a summary of the new information;

(7) Copies of source documents from which new information used to support the petition has been obtained (attached as appendices to the petition); and

(8) A financial certification or disclosure statement or both as required by part 54 of this chapter.

(b) Each petition submitted pursuant to this section shall be:

(1) For devices regulated by the Center for Devices and Radiological Health, addressed to the Food and Drug Administration, Center for Devices and Radiological Health, Office of Policy Staff, 10903 New Hampshire Ave., Bldg. 66, Rm. 5445, Silver Spring, MD 20993-0002; for devices regulated by the Center for Biologics Evaluation and Research, addressed to the Food and Drug Administration, Center for Biologics Evaluation and Research, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G112, Silver Spring, MD 20993-0002; for devices regulated by the Center for Drug Evaluation and Research, addressed to the Food and Drug Administration, Center for Drug Evaluation and Research, Central Document Control Room, 5901-B Ammendale Rd., Beltsville, MD 20705-1266, as applicable.

(2) Marked clearly with the section of the Federal Food, Drug, and Cosmetic Act under which the petition is being submitted, i.e., “513(e),” “513(f)(3),” “514(b),” “515(b),” or “520(l) Petition”;

(3) Bound in a volume or volumes, where necessary; and

(4) Submitted in an original and two copies.

[43 FR 32993, July 28, 1978, as amended at 49 FR 14505, Apr. 12, 1984; 53 FR 11253, Apr. 6, 1988; 55 FR 11169, Mar. 27, 1990; 63 FR 5254, Feb. 2, 1998; 65 FR 17137, Mar. 31, 2000; 73 FR 49942, Aug. 25, 2008; 75 FR 20916, Apr. 22, 2010; 79 FR 77388, Dec. 24, 2014; 82 FR 39535, Aug. 21, 2017; 83 FR 64456, Dec. 17, 2018; 85 FR 18443, Apr. 2, 2020]