As more and more devices reach the US market through FDA's de novo pre-market pathway, the agency is formalizing its rules of the road for the approach that represents a middle-way between 510(k)s and PMAs.
The agency issued a proposed rule Dec
A new proposed rule on the de novo classification process does not advance any major policy reforms, but its release underscores the growing popularity of the regulatory pathway that provides flexibility for US FDA and industry in the space between 510(k)s and PMAs.
As more and more devices reach the US market through FDA's de novo pre-market pathway, the agency is formalizing its rules of the road for the approach that represents a middle-way between 510(k)s and PMAs.
The agency issued a proposed rule Dec
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.