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:
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;
The reasons why compliance with the performance standard is unnecessary or unfeasible;
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
Other information justifying the exemption or variance.
An exemption or variance is not effective until the agency approves the request under § 10.30(e)(2)(i) of this chapter.
At 62 FR 25477, May 9, 1997, § 898.14 was stayed pending Office of Management and Budget approval of information collection and recordkeeping requirements.
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