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MedTech DiveFDA Finalizes Guidance on Cybersecurity for Medical Devices

New Guidelines Aim to Streamline Cybersecurity Protocols and Reflect Emerging Threats

The FDA has recently released its final guidance on cybersecurity requirements for medical devices, just days before the October 1 deadline. This updated document replaces the 2014 version and aims to help manufacturers navigate the rapidly changing landscape of cybersecurity threats and regulations.

HCN Medical Memo
The FDA’s new cybersecurity guidance for medical devices signifies a step forward in ensuring patient data safety and device functionality. It is crucial to be aware of these guidelines when considering the integration of new medical devices into your practice, as they set the standard for cybersecurity compliance moving forward.

Key Points
  • The FDA was empowered by Congress last year to issue “refuse to accept” decisions for applicants that do not meet cybersecurity requirements.
  • The new guidance comes as an update to a 2014 document and reflects emerging threats and the need for effective mitigations throughout a product’s lifecycle.
  • Medical device manufacturers and trade group AdvaMed have generally responded favorably to the draft guidance, praising its “sensible approach.”
  • AdvaMed requested that cybersecurity be risk-based and for a two-year transition period; the final text includes a new section on cybersecurity risk assessment.

The FDA has made changes based on more than 1,800 comments, aligning the guidance with industry best practices and clarifying documentation and interoperability considerations.

Additional Points
  • The FDA has not changed its plan to start using its new powers from October 1, as set in March.
  • The agency has clarified that cybersecurity controls should not prohibit a user from accessing their device data.

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