AI-driven insights for regulatory decision-making in drug-device combinations

Medical devices or drug-device combination products are achieving acceptance for their use in early diagnosis, examination and the treatment delivery of various diseases. Artificial intelligence is reforming the healthcare domain by providing tremendous opportunities through increased precision detection, patient - specific treatment plan and improved clinical outcomes. Although these innovations provide potential advantages, their limitations in digital safety, data protection, and data authenticity in real-world cannot be overlooked along with other ethical challenges. Recent regulatory guidelines and good AI practice are designed to mitigate these challenges by continuous monitoring of AI models and constant improvement in them. Lastly, regulatory agency is expected to expedite research on AI accompanied devices for better clinical precision and improved tailored treatments.