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.

Regulatory ComplianceNaveen AgarwalApril 9, 2019regulatory compliance, regulatory policy, artificial intelligence, artificial intelligence in healthcare, FDA regulationComment