‘Til I Hear It From Congress: FDASLA to Direct Publication of Final OTC Hearing Aid Rules
FDA Law Blog
JUNE 21, 2022
Back in the 2017 user fee package, the FDA Reauthorization Act (also called “FDARA”), Congress set forth a process for establishing a category of OTC hearing aids—hearing aids that may be sold directly to patients without the intervention of a medical provider. Nor is it unusual for FDA to give FDA a deadline (which is often missed).
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