The US FDA is clarifying how it evaluates real-world data when making regulatory decisions on medical devices.
The Food and Drug Administration draft guidance published on 19 December explains how the agency determines if real-world data (RWD) is sufficient for generating real-world evidence (RWE) that can be used when making regulatory decisions on medical devices.
The document, “
NeuroOne is preparing to submit its OneRF Trigeminal Nerve Ablation System to the US FDA for treating trigeminal neuralgia, a chronic facial pain condition. CEO Dave Rosa told Medtech Insight that he expects a possible product launch by fall 2025.
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.
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