A regulation establishing, amending, or revoking a performance standard will set forth the date upon which it will take effect. To the extent practical, consistent with the public health and safety, such effective date will be established so as to minimize economic loss to, and disruption or dislocation of, domestic and international trade.
Except as provided in paragraph (c) of this section, no regulation establishing, amending, or revoking a standard may take effect before 1 year after the date of its publication unless:
The Food and Drug Administration determines that an earlier effective date is necessary to protect the public health and safety; or
The standard has been established for a device that, by the effective date of the standard, has been reclassified from class III to class II.
The Food and Drug Administration may declare a proposed regulation amending a standard effective on publication in the Federal Register if it determines that making the regulation so effective is in the public interest. A proposed amendment of a performance standard made effective upon publication may not prohibit the introduction or delivery for introduction into interstate commerce of a device that conforms to the standard without the change or changes provided in the proposed amendment until the effective date of any final action on the proposal.
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 plans 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 easy access to affordable legal services through a network of independent 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 network law firms.
You should not disclose confidential or potentially incriminating information to LegalFix—you should only communicate such information to your network 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 plans, and access to the LegalFix networks of law firms are subject to the LegalFix Terms of Service and Privacy Policy.