[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: 21CFR860.132]

[Page 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. 860.132  Procedures when the Commissioner initiates a performance standard or premarket approval proceeding under section 514(b) or 515(b) of the act.

    (a) Sections 514(b) and 515(b) of the act require the Commissioner 
to provide, by notice in the Federal Register, an opportunity for 
interested parties to request a change in the classification of a device 
based upon new information relevant to its classification when the 
Commissioner initiates a proceeding either to develop a performance 
standard for the device if in class II, or to promulgate a regulation 
requiring premarket approval for the device if in class III. In either 
case, if the Commissioner agrees that the new information warrants a 
change in classification, the Commissioner will publish in the Federal 
Register notice of the Commissioner's intent to initiate a proceeding 
under section 513(e) of the act and Sec. 860.130 to effect such a 
change.
    (b) The procedures for effecting a change in classification under 
sections 514(b) and 515(b) of the act are as follows:
    (1) Within 15 days after publication of the Commissioner's notice 
referred to in paragraph (a) of this section, an interested person files 
a petition for reclassification in accordance with Sec. 860.123.
    (2) The Commissioner consults with the appropriate classification 
panel with regard to the petition in accordance with Sec. 860.125.
    (3) Within 60 days after publication of the notice referred to in 
paragraph (a) of this section, the Commissioner, by order published in 
the Federal Register, either denies the petition or gives notice of his 
intent to initiate a change in classification in accordance with 
Sec. 860.130.