If you thought there was nothing keeping the director of the FDA’s device center up at night, you’d be wrong: He can’t sleep when he considers the growing threat that the cybersecurity of medical devices and hospital networks could pose significant risks to patients.
US Losing Its Digital Edge And Cybersecurity Are Shuren’s Chief Concerns
If the US Congress fails to give the Food and Drug Administration the authority it needs to regulate advancing technologies, the country could forfeit its leadership in the digital space to other countries eager to take its place.
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The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.
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Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.
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A seemingly humorous social media post on April Fool’s Day struck a nerve with regulatory experts, reflecting real concerns about recent actions by the US Food and Drug Administration.
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Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
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Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.
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Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.
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Swiss medtech exporters seek urgent diplomatic action from the Swiss Federal Council in a bid to overturn the 2 April US decision to put tariffs on goods imports.