CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 898—PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES > 898.14—Exemptions and variances.

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.

Code of Federal Regulations

Effective Date Note: At 62 FR 25477, May 9, 1997, § 898.14 was stayed pending Office of Management and Budget approval of information collection and recordkeeping requirements.