[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR860.130]

[Page 166-167]
 
                        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. 860.130  General procedures under section 513(e) of the act.

    (a) Section 513(e) of the act applies to reclassification 
proceedings under the act based upon new information.
    (b) A proceeding to reclassify a device under section 513(e) may be 
initiated:
    (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 Sec. 860.132); or
    (3) In response to the petition of an interested person, based upon 
new information, filed in accordance with Sec. 860.123.
    (c) By regulation promulgated under this section, the Commissioner 
may change the classification from class III into:
    (1) Class II if the Commissioner determines that special controls in 
addition to general controls would provide reasonable assurance of the 
safety and effectiveness of the device and there is sufficient 
information to establish special controls to provide assurance; or
    (2) Class I if the Commissioner determines that general controls 
would provide reasonable assurance of the safety and effectiveness of 
the device.
    (d) The rulemaking procedures in Sec. 10.40 of this chapter apply to 
proceedings to reclassify a device under section 513(e), except that the 
Commissioner may secure a recommendation with respect to a proposed 
reclassification from the classification panel to which the device was 
last referred. The panel will consider a proposed reclassification 
submitted to it by the Commissioner in accordance with the consultation 
procedures of Sec. 860.125. Any recommendation submitted to the

[[Page 167]]

Commissioner by the panel will be published in the Federal Register when 
the Commissioner promulgates a regulation under this section.
    (e) Within 180 days after the filing of a petition for 
reclassification under this section, the Commissioner, by order 
published in the Federal Register, will either deny the petition or give 
notice of his intent to initiate a change in the classification of the 
device.
    (f) If a device is reclassified under this section, the regulation 
effecting the reclassification may revoke any special control or 
premarket approval requirement that previously applied to the device but 
that is no longer applicable because of the change in classification.
    (g) A regulation under this section changing the classification of a 
device from class III to class II may provide that such classification 
will not take effect until the effective date of a special control for 
the device established under section 514 of the act.

[43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992]