FDA Guidance Shows a Regulatory Path Forward for Interoperable Devices

Market for interconnected medical devices is projected to grow but the regulatory pathway is still evolving. A new FDA guidance offers helpful recommendations for design and premarket submission.

Regulatory ComplianceNaveen AgarwalApril 2, 2020FDA Guidance, interoperable devices, FDA on interoperable devices, interoperability, medical device innovation, regulatory policy, medical device regulatory policy, premarket guidance, FDA premarket guidance, interoperable medical devicesComment

How FDA is Shaping a Regulatory Policy for Device Cybersecurity

Updated draft guidance provides recommendations for design, labeling, and premarket documentation. Industry response points to a long road ahead before it can be finalized.

Regulatory ComplianceNaveen AgarwalNovember 20, 2019FDA medical devices, FDA guidance, regulatory policy, regulatory news, device cybersecurity, medical device security, medical device cybersecurity, FDA safety, FDA regulation, WannaCry ransomware attack, WannaCry ransomware, URGENT/11, healthcare, cyberthreats in healthcare, healthcare securityComment

Regulatory Policy in the Age of Artificial Intelligence

Artificial intelligence (AI) based devices are unique in their ability to learn from real-world use and experience, which can translate to rapid improvement in performance and new applications. In a sign of recognition of this capability, the FDA is proposing a new regulatory framework for review and approval of modifications to these devices after they have been cleared or approved.