The Food and Drug Administration’s final guidance on opioid abuse seeks to help device developers in tackling an ongoing national crisis.
FDA Drops Final Guidance On Devices Designed To Treat Opioid Abuse
The FDA has published final guidance to assist developers of medical devices designed to treat opioid use disorder, along with considerations for sponsors of clinical studies to evaluate those devices.
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AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
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Cybersecurity, sustainability and regulatory intelligence all need factoring into risk management today as AI and data availability change the goalposts. Eight experts tell Medtech Insight how compliance efforts must adapt.
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Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.
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As deadlines approach, the regulatory landscape for medtech batteries is set to change, with an emphasis on sustainability and ethical practices.
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Cybersecurity, sustainability and regulatory intelligence all need factoring into risk management today as AI and data availability change the goalposts. Eight experts tell Medtech Insight how compliance efforts must adapt.
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About 3,500 full-time FDA employees are expected to be laid off as part of a restructuring of the Health and Human Services Department. Experts questioned whether the cuts could be implemented without harming FDA’s core mission.
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The IVD industry’s new 10-point plan for healthcare change shows that medtechs will keep calling the German government to account. Tariffs, sector resilience, digital functionality are among the pressing issues industry wants answers to.