The FDA has issued new guidelines on cybersecurity for medical devices. The guidelines aim to prevent security vulnerabilities in medical devices, such as pacemakers and insulin pumps, that could be exploited by hackers. The FDA recommends that manufacturers prioritize cybersecurity considerations throughout the development and production process, and that they conduct thorough testing and documentation to ensure the security and reliability of their devices. Failure to comply with the FDA’s cybersecurity requirements can result in delays in market entry, reputational damage, and enforcement actions. Companies are urged to take proactive measures to address cybersecurity risks and to stay informed about industry standards and regulatory requirements.
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