FDA Cautions EUA-Holders They Have Same MDR Reporting Responsibilities As Other Manufacturers
In further sign the agency is tightening oversight of EUA products, regulators have set up a Q&A web page for manufacturers explaining their responsibilities to report adverse events.
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As the agency is starting to tighten EUA regulations, it says the new codes will help it better track adverse events and imports related to the products.
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The US regulatory agency will hold a two-day online workshop in April on how transbronchoscopic thermal ablation devices may be developed to treat intermediate-stage lung tumors known as oligometastases to the lung (OML).