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Code of Federal Regulations (Last Updated: May 6, 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 |
§ 808.55 - California.
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§ 808.55 California.
(a)The following California medical device requirements are
enforceable notwithstanding section 521 of the act because the Food and Drug Administration exempted them from preemptionpreempted under section 521(
ba) of the
act: Business and Professions Code sections 3365 and 3365.6. (b) The following California medical device requirements are preempted by section 521 of the actFederal Food, Drug, and Cosmetic Act, and FDA has denied them
anexemption from preemption:
1)(
(a) Medical devices; general provisions. Sherman Food, Drug, and Cosmetic Law
), Division 21 of the California Health and Safety Code
26641, sections 26207, 26607, 26614, 26615, 26618, 26631, 26640, and
.26441, to the extent that they apply to devices
(3)(2) Sherman Food, Drug, and Cosmetic Law, section 26463(m) to the extent that it applies to hearing aids.
; and
(b) Ophthalmic devices; quality standards. California Business and Professions Code, section 2541.3
,to the extent that it requires adoption of the American National Standards Institute standards Z-80.1 and Z-80.2.