Category: Legislation

Legislation

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WS Audiology is ‘First Hearing Aid Company’ to Receive Eu MDR Certification

The certification process at WS Audiology, with hearing aids and related software in scope, started with on-site audits in October and November of 11 sites in Europe, the US, China, and Singapore. During these audits, the company reports that its new quality management system was reviewed by notified body TüV Süd to ensure compliance to the EU Medical Device Regulation.

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President Trump Signs OTC Hearing Aid Legislation into Law

On Friday, August 18, President Donald Trump signed into law today the Food and Drug Administration Reauthorization Act of 2017, legislation that includes the Over the Counter Hearing Aid Act designed to provide greater public accessibility and affordability with over-the-counter (OTC) hearing aids. FDA will now be charged with creating and regulating a new class of OTC hearing aids.

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