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Medical Devices / Regulatory Affairs

Lawmakers Consider Adding Four Device Bills to MDUFA Reauthorization

May 3, 2017

A House subcommittee held a hearing Tuesday on the MDUFA reauthorization and four additional device-related measures it is considering attaching to the user fee legislation.

The draft MDUFA bill would extend the existing MDUFA programs to 2022, and include new fees for de novo reviews. Anticipated fees to be collected would increase from $130.2 million for the current fiscal year to $183.3 million in fiscal 2018 and to $213.7 million for fiscal 2022.

One bill the lawmakers may combine with the MDUFA package aims to make hearing aids more accessible over the counter by doing away with the need for an examination or signed waiver in order for a patient to buy or receive the device.

The bill would:

  • Make hearing aids, intended to be used by adults to compensate for mild to moderate hearing impairment, available over the counter;
  • Remove requirements that consumers obtain a medical evaluation or sign a waiver of that examination in order to obtain an OTC hearing aid;
  • Require the FDA to issue regulations with safety and labeling requirements for this new category of OTC hearing aids;
  • Maintain existing safety, labeling, and manufacturing protections; and
  • Require the FDA to update its draft guidance on personal sound amplification products — consumer electronics products that may use similar technology to hearing aids, but are intended for use by individuals with normal hearing.

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