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:
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;
The reasons why compliance with the performance standard is unnecessary or unfeasible;
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
Other information justifying the exemption or variance.
An exemption or variance is not effective until the agency approves the request under § 10.30(e)(2)(i) of this chapter.
At 62 FR 25477, May 9, 1997, § 898.14 was stayed pending Office of Management and Budget approval of information collection and recordkeeping requirements.
Copyright ©2024 LegalFix. All rights reserved. LegalFix is not a law firm, is not licensed to practice law, and does not provide legal advice, services, or representation. The information on this website is an overview of the legal insurance products you can purchase—or that may be provided by your employer as an employee benefit or by your credit union or other membership group as a membership benefit.
LegalFix provides its members with access to legal services through a network of provider law firms. LegalFix, its corporate entity, and its officers, directors, employees, agents, and contractors do not provide legal advice, services, or representation—directly or indirectly.
The articles and information on the site are not legal advice and should not be relied upon—they are for information purposes only. You should become a LegalFix member to get legal services from one of our provider law firms.
You should not disclose confidential or potentially incriminating information to LegalFix—you should only communicate such information to your provider law firm.
The benefits and legal services described in the LegalFix legal plans are not always available in all states or with all plans. See the legal plan Benefit Overview and the more comprehensive legal plan contract during checkout for coverage details in your state.
Use of this website, the purchase of legal insurance products, and access to the LegalFix network of provider law firms are subject to the LegalFix Terms of Service and Privacy Policy.
