[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR898.14]

[Page 552-553]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 898_PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT
CABLES--Table of Contents
 
Sec. 898.14  Exemptions and variances.

    (a) 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. The petition shall also contain 
the following:
    (1) The name of the device, the class in which the device has been 
classified, and representative labeling showing the intended uses(s) of 
the device;
    (2) The reasons why compliance with the performance standard is 
unnecessary or unfeasible;
    (3) A complete description of alternative steps that are available, 
or that the petitioner has already taken, to ensure that a patient will 
not be inadvertently connected to hazardous voltages via an unprotected 
patient cable or electrode lead wire for intended use with the device; 
and
    (4) Other information justifying the exemption or variance.
    (b) An exemption or variance is not effective until the agency 
approves the request under Sec. 10.30(e)(2)(i) of this chapter.

    Effective Date Note: At 62 FR 25477, May 9, 1997, Sec. 898.14 was 
stayed pending Office of

[[Page 553]]

Management and Budget approval of information collection and 
recordkeeping requirements.

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