21 CFR §898.14

1. (a)A request for an exemption or variance shall be submitted in the form of a petition under § 10.30 of this chapter and shall comply with the requirements set out therein. The petition shall also contain the following:
   1. (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. (2)The reasons why compliance with the performance standard is unnecessary or unfeasible;
   3. (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. (4)Other information justifying the exemption or variance.
2. (b)An exemption or variance is not effective until the agency approves the request under § 10.30(e)(2)(i) of this chapter.