‘Til I Hear It From Congress: FDASLA to Direct Publication of Final OTC Hearing Aid Rules
FDA Law
JUNE 21, 2022
This provision adds nothing substantive to the OTC hearing aid regulatory scheme—it merely tells FDA that it has 30 days from enactment of the user fee legislation to issue its final rules governing OTC hearing aids. Directing FDA to issue rules isn’t out of the ordinary.
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