The most recent user-fee program trends report from FDA, with data current to March 31, 2014, shows improvements in 510(k) review metrics.
The total average time to a 510(k) decision by FDA continues to improve, according to the agency’s most recent quarterly update
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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.
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.
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.
Its move comes as the Swiss recognize the need to ensure adequate supplies on medical devices in its country.
