{"data":{"id":"us/21-cfr-898.14","jurisdiction":"us","citation":"21 CFR 898.14","heading":"Exemptions and variances.","body":"(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:\n(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;\n(2) The reasons why compliance with the performance standard is unnecessary or unfeasible;\n(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\n(4) Other information justifying the exemption or variance.\n(b) An exemption or variance is not effective until the agency approves the request under § 10.30(e)(2)(i) of this chapter.","path":["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"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"c2f2a73cfa4e5b8c14f65cba3d0f17ea3783b68d74b91a924fb81e26220636c8","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-898.13","next":"us/21-cfr-900.1"},"notice":"GroundRules: Original legal text. Not legal advice."}