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Code of Federal Regulations (Last Updated: October 10, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 808 - Exemptions from Federal Preemption of State and Local Medical Device Requirements |
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Subpart C - Listing of Specific State and Local Exemptions |
§ 808.93 - Texas.
Latest version.
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§ 808.93 Texas.
(a) The following Texas medical device requirement is enforceable notwithstanding section 521(a) of the act because the Food and Drug Administration has exempted it from preemption under section 521(b) of the act: Vernon's Civil Statutes, Article 4566, section 14(b) on the condition that, in enforcing this requirement, Texas apply the definition of “used hearing aid” in § 801.420(a)(6) of this chapter.
(b) The following Texas medical device requirement is preempted by section 521(a) of the act, and the Food and Drug Administration has denied it an exemption from preemption under section 521(b) of the act: Vernon's Civil Statutes, Article 4566, section 14(d).
[45 FR 67337, Oct. 10, 1980]