FDA will host a meeting in April to discuss the prospects of exempting a segment of hearing aids from FDA's Quality System Regulation
FDA To Weigh Proposals For Lightened Hearing-Aid Regs
Following a White House report arguing that the current regulation of hearing aids is stifling innovation and raising costs, FDA has scheduled a gathering to discuss the future of hearing aid regulations. The agency has also reopened a comment period on a pending draft guidance. An industry trade group, however, is skeptical of proposals that have been put forward.
More from Regulation
• By
Manufacturers of medical products would be foolish to think that recent upheavals at the US FDA will result in a lack of inspections in the coming years. A panel of experts discussed the current state of inspections during a webinar hosted by the Food and Drug Law Institute.
• By
The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.
• By
A New South Korean law, the Digital Medical Products Act, enhances regulation for digital health products. Medical devices in the country are categorized both by risk and by similarity to already authorized devices. The approval process may stretch to 515 days for new manufacturers.
• By
Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.