Lexology April 17, 2023
ALERT: Recent guidance from the Food and Drug Administration (“FDA”) clarifies a procedural issue for premarket submissions related to cybersecurity of medical devices and emphasizes the importance of collaboration between the FDA and medical device manufacturers. Providers using medical devices in their practice should pay attention to these rulings because they impacts the providers’ ability to educate and engage their patients.
SUMMARY: As the healthcare industry becomes increasingly reliant on technology, medical device cybersecurity has become a critical concern not just for manufacturers, but also for providers and patients. New legislation addressing cybersecurity requirements for medical devices and recent guidance from the FDA highlight the importance of addressing cybersecurity risks in medical devices, as well as taking proactive steps to...
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