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Home » FDA’s hearing aid draft rule pushes agency back into debate over class II device preemption
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FDA’s hearing aid draft rule pushes agency back into debate over class II device preemption

Oct. 19, 2021
By Mark McCarty
The FDA published a draft rule on Oct. 19 for over-the-counter hearing aids, four years after the Food and Drug Administration Reauthorization Act (FDARA) had directed the agency to do so by 2020. One of the potentially more problematic aspects of the draft is that the rule would be preemptive of state law on several points, including consumer protections, a consideration that could serve as a flashpoint in future litigation.
BioWorld MedTech Regulatory Ear, nose and throat Hearing aid U.S. FDA

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