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Growing Concerns With Cybersecurity Hacks of Devices

While the agency released its first guidance on cybersecurity requirements a decade ago, a top FDA official says the agency has seen a spike in potential vulnerabilities over the past year and a half, and has been working with manufacturers and other stakeholders to fix them before someone gets hurt.

Concerns about cybersecurity threats to medical devices have grown over the past year and half, FDA affirms, as more and more wireless medical devices have been found to have potential vulnerabilities that hackers could take advantage of and endanger patients.

The agency has been concerned with such risks for some time, going back at least to the 2005 release of a guidance addressing cybersecurity issues for network devices with off-the-shelf...

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