part_subject: "PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES"
subpart_code: "B"
subpart_subject: "Requirements for Specific Medical Devices"
section_number: "898.14"
section_subject: "Exemptions and variances."
cfr_reference: "21 CFR 898.14"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.