Medical Device Cybersecurity: Areas Of Concern In Latest FDA Guidance [Forbes]
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Source: Forbes
Medical device cybersecurity is a dynamic and evolving space. As more devices enter the market and connect to the internet, the risk of these devices being compromised increases—ultimately increasing the risk to patient safety. The Food and Drug Administration (FDA) oversees medical device submission approvals. The agency has realized that medical devices are now part of the threat landscape and can be vulnerable to hacking and cyberattacks. PROMOTED In September 2023, the FDA for the cybersecurity of medical devices, likely in response to the revealing that 53% of medical and internet-connected devices had critical vulnerabilities. The FDA decided it was time to modernize its approach to medical device cybersecurity. Therefore, it updated of the Food, Drug, and Cosmetic Act (FD&C Act). What Manufacturers Need To Know The FDA noted that vigilance regarding cyber risks in medical devices is a shared responsibility. However, most requirements relate to device manufacturers an
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