The Food and Drug Administration (FDA) is amending its regulations to clarify that the Agency will provide an opportunity for an informal hearing in connection with a proposed rule to ban a device with a special effective date. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
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Banned Devices; General Provisions; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulations to clarify that the Agency will provide an opportunity for an informal hearing in connection with a proposed r...
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80 FR 31299
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“Banned Devices; General Provisions; Technical Amendment,” thefederalregister.org (June 2, 2015), https://thefederalregister.org/documents/2015-13329/banned-devices-general-provisions-technical-amendment.