[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR860.134]

[Page 168-169]
 
                        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. 860.134  Procedures for ``new devices'' under section 513(f) of the act and reclassification of certain devices.

    (a) Section 513(f)(2) of the act applies to proceedings for 
reclassification of a device currently in class III by operation of 
section 513(f)(1) of the act. This category includes any device that is 
to be first introduced or delivered for introduction into interstate 
commerce

[[Page 169]]

for commercial distribution after May 28, 1976, unless:
    (1) It is substantially equivalent to another device that was in 
commercial distribution before that date and had not been regulated 
before that date as a new drug; or
    (2) It is substantially equivalent to another device that was not in 
commercial distribution before such date but which has been classified 
into class I or class II; or
    (3) The Commissioner has classified the device into class I or class 
II in response to a petition for reclassification under this section.

The Commissioner determines whether a device is ``substantially 
equivalent'' for purposes of the application of this section. If a 
manufacturer or importer believes that a device is not ``substantially 
equivalent'' but that it should not be in class III under the criteria 
in Sec. 860.3(c), the manufacturer or importer may petition for 
reclassification under this section. A manufacturer or importer who 
believes that a device is ``substantially equivalent'' and wishes to 
proceed to market the device shall submit a premarket notification in 
accordance with part 807 of this chapter. After considering a premarket 
notification, the Commissioner will determine whether the device is 
``substantially equivalent'' and will notify the manufacturer or 
importer of such determination in accordance with part 807 of this 
chapter.
    (b) The procedures for effecting reclassification under section 
513(f) of the act are as follows:
    (1) The manufacturer or importer of the device petitions 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 and allows 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) After determining that the petition contains no deficiencies 
precluding a decision on it, the Commissioner may for good cause shown 
refer the petition to the appropriate classification panel for its 
review and recommendation whether to approve or deny the petition.
    (4) Within 90 days after the date the petition is referred to the 
panel, following the review procedures set forth in Sec. 860.84(c) for 
the original classification of an ``old'' device, the panel submits to 
the Commissioner its recommendation containing the information set forth 
in Sec. 860.84(d). A panel recommendation is regarded as preliminary 
until the Commissioner has reviewed it, discussed it with the panel, if 
appropriate, and developed a proposed reclassification order. 
Preliminary panel recommendations are filed in the Dockets Management 
Branch upon receipt and are available to the public upon request.
    (5) The panel recommendation is published in the Federal Register as 
soon as practicable and interested persons are provided an opportunity 
to comment on the recommendation.
    (6) Within 90 days after the panel's recommendation is received (and 
no more than 210 days after the date the petition was filed), the 
Commissioner denies or approves the petition by order in the form of a 
letter to the petitioner. If the Commissioner approves the petition, the 
order will classify the device into class I or class II in accordance 
with the criteria set forth in Sec. 860.3(c) and subject to the 
applicable requirements of Sec. 860.93, relating to the classification 
of implants, life-supporting or life-sustaining devices, and 
Sec. 860.95, relating to exemptions from certain requirements of the 
act.
    (7) Within a reasonable time after issuance of an order under this 
section, the Commissioner announces the order by notice published in the 
Federal Register.

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