New US FDA draft guidance on 510(k)s for peripheral vascular atherectomy devices asks sponsors to submit clinical trial data due to lack of a good animal model.
US FDA issued a draft guidance document July 27 for peripheral vascular atherectomy devices, asking sponsors submit clinical evidence to help prove the new devices are substantially equivalent to their predicates.
While clinical trial data is not requested for a majority of 510(k) devices, clinical data in about 10%
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.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. 25 documents have been posted on the tracker since its last update.
