[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: 21CFR860.136]

[Page 176]
 
                        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. 860.136  Procedures for transitional products under section 520(l) of the act.

    (a) Section 520(l)(2) of the act applies to reclassification 
proceedings initiated by a manufacturer or importer for reclassification 
of a device currently in class III by operation of section 520(l)(1) of 
the act. This section applies only to devices that the Food and Drug 
Administration regarded as ``new drugs'' before May 28, 1976.
    (b) The procedures for effecting reclassification under section 
520(l) are as follows:
    (1) The manufacturer or importer of the device files a petition for 
reclassification of the device in accordance with Sec. 860.123.
    (2) Within 30 days after the petition is filed, the Commissioner 
notifies the petitioner of any deficiencies in the petition that prevent 
the Commissioner from making a decision on it, allowing the petitioner 
to supplement a deficient petition. Within 30 days after any 
supplemental material is received, the Commissioner notifies the 
petitioner whether the petition, as supplemented, is adequate for 
review.
    (3) The Commissioner provides the petitioner an opportunity for a 
regulatory hearing conducted in accordance with part 16 of this chapter.
    (4) The Commissioner consults with the appropriate classification 
panel with regard to the petition in accordance with Sec. 860.125.
    (5) Within 180 days after the petition is filed (where the 
Commissioner has determined it to be adequate for review), the 
Commissioner, by order in the form of a letter to the petitioner, either 
denies the petition or classifies the device into class I or class II in 
accordance with the criteria set forth in Sec. 860.3(c).
    (6) Within a reasonable time after issuance of an order under this 
section, the Commissioner announces the order by notice published in the 
Federal Register.