[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: 21CFR821.2]

[Page 152]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 821--MEDICAL DEVICE TRACKING REQUIREMENTS--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 821.2  Exemptions and variances.

    (a) A manufacturer, importer, or distributor may seek an exemption 
or variance from one or more requirements of this part.
    (b) A request for an exemption or variance shall be submitted in the 
form of a petition under Sec. 10.30 of this chapter and shall comply 
with the requirements set out therein, except that a response shall be 
issued in 90 days. The Director or Deputy Directors, CDRH, or the 
Director, Office of Compliance, CDRH, shall issue responses to requests 
under this section. The petition shall also contain the following:
    (1) The name of the device and device class and representative 
labeling showing the intended use(s) of the device;
    (2) The reasons that compliance with the tracking requirements of 
this part is unnecessary;
    (3) A complete description of alternative steps that are available, 
or that the petitioner has already taken, to ensure that an effective 
tracking system is in place; and
    (4) Other information justifying the exemption or variance.
    (c) An exemption or variance is not effective until the Director, 
Office of Compliance and Surveillance, CDRH, approves the request under 
Sec. 10.30(e)(2)(i) of this chapter.
    (d) For petitions received under this section before August 29, 
1993, FDA will, within 60 days, approve or disapprove the petition or 
extend the effective date of this part for the device that is the 
subject of the petition. Any extension that FDA grants to the effective 
date will be based upon the additional time FDA needs to complete its 
review of the petition.

[58 FR 43447, Aug. 16, 1993, as amended at 59 FR 31138, June 17, 1994]