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Senate HELP Committee Approves FDA User Fee Legislation with OTC Hearing Aid Provision

Senate HELP Committee Approves FDA User Fee Legislation with OTC Hearing Aid Provision

After delaying the mark up by one day, the Senate Health Education Labor and Pensions (HELP) Committee met on Thursday, May 11 to consider legislation (S. 934) that would reauthorize the US Food and Drug Administration (FDA) drug and device user fees. Before voting, the Senate HELP Committee unanimously adopted the manager’s amendment released on May 8. The manager’s amendment included a number of added provisions, including one that directs the FDA to develop a category of over-the-counter hearing aids. The Senate HELP Committee then voted to approve the device user fee package. This legislation, including the OTC hearing aid provision, will now move to the full Senate for consideration. The current authorization for the user fees expires on September 30 so we anticipate the Senate to act quickly on this legislation.

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