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 under which it is filed, shall include the following:
(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 completed supplemental data sheet applicable to the device for which reclassification is requested;
(4)
A completed classification questionnaire applicable to the device for which reclassification is requested;
(6)
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;
(7)
Representative data and information known by the petitioner that are unfavorable to the petitioner's position;
(8)
If the petition is based upon new information under section 513(e), 514(b), or 515(b) of the act, a summary of the new information;
(9)
Copies of source documents from which new information used to support the petition has been obtained (attached as appendices to the petition).
(10)
A financial certification or disclosure statement or both as required by part 54 of this chapter.
(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, Regulations Staff, 10903 New Hampshire Ave., Bldg. 66, rm. 4425, Silver Spring, MD 20993-0002; for devices regulated by the Center for Biologics Evaluation and Research, addressed to the Document Control Center (HFM-99), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448; for devices regulated by the Center for Drug Evaluation and Research, addressed to the Central Document Control Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266, as applicable.
(2)
Marked clearly with the section of the act under which the petition is being submitted, i.e., “513(e),” “513(f),” “514(b),” “515(b),” or “520(l) Petition”;