§898.14. Exemptions and variances.
21 C.F.R. § 898.14
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.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 351, 352, 360c, 360d, 360gg-360ss, 371, 374; 42 U.S.C. 262, 264.
Source
Source: 62 FR 25497, May 9, 1997, unless otherwise noted.