GroundRules
21 CFR 898.14: Exemptions and variances.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 898—PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON