21 CFR § 898.14 - Exemptions and variances.

---
identifier: "/us/cfr/t21/s898.14"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 898.14 - Exemptions and variances."
title_number: 21
title_name: "Food and Drugs"
section_number: "898.14"
section_name: "Exemptions and variances."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "898"
part_name: "PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 352, 360c, 360d, 360gg-360ss, 371, 374; 42 U.S.C. 262, 264."
regulatory_source: "62 FR 25497, May 9, 1997, unless otherwise noted."
cfr_part: "898"
---


# 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 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) 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.