A new FDA guidance calls on the medical device community to be more proactive when it comes to developing a solid set of cybersecurity controls to ensure safety and efficacy for users.

However, the agency isn’t putting the entire onus on medical device manufacturers. The FDA “recognizes that medical device security is a shared responsibility between stakeholders, including healthcare facilities, patients, providers,” and device makers. Those are comforting words, but we all know the buck ultimately stops with manufacturers. The key is to be prepared for any eventuality.

For the most part, the FDA’s recommendations fall under the “basic common sense” category. However, it is still valuable to understand FDA inspectors’ general marching orders if they come calling at your facility.

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