§ 898.14. Exemptions and variances.
177 words·~1 min read·
/us/cfr/t21/s§ 898.14·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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.