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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR898.14]
See Related Information on Exemptions and variances. in CDRH databases



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.

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