---
kind: "section"
citation: "21 C.F.R. § 898.14"
title: "21"
number: "898.14"
heading: "Exemptions and variances."
url: "https://uscodex.org/cfr/21/898.14"
---

# §898.14. Exemptions and variances.

- (a) A request for an exemption or variance shall be submitted in the form of a petition under [§ 10.30](/cfr/21/10.30.md) 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 [§ 10.30(e)(2)(i)](/cfr/21/10.30.md?p=e-2-i) of this chapter.

## Notes

### 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.