[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: 21CFR898.14]

[Page 522-523]
 
                        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.


[[Page 523]]



    Effective Date Note: At 62 FR 25477, May 9, 1997, Sec. 898.14 was 
stayed pending Office of Management and Budget clearance for information 
collection.

[[Page 524]]