[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR860.123]

[Page 173]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES--Table of Contents
 
                       Subpart C--Reclassification
 
Sec. 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:
    (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 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;
    (5) A statement of the basis for disagreement with the present 
classification status of the device;
    (6) A full statement of the reasons, together with supporting data 
satisfying the requirements of Sec. 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.
    (b) Each petition submitted pursuant to this section shall be:
    (1) Addressed to the Food and Drug Administration, Center for 
Devices and Radiological Health, Regulations Staff (HFZ-215), 1350 
Piccard Dr., Rockville, MD 20857;
    (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'';
    (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]