CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR898.14]

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

Sec. 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.

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.