Past Webinar – Unlocking Success: FDA Regulatory Strategies for AgeTech Devices and AI
https://www.youtube.com/watch?v=0dpRR_cDPPs Abstract: This webinar explores regulatory strategies for bringing AgeTech devices and AI innovations to market under FDA oversight. Panelists provided an overview of FDA pathways, including 510(k), De Novo, and Pre-Market Approval (PMA), highlighting how device classification and intended use shape regulatory requirements. Discussion emphasized unique challenges for software as a medical device (SaMD), clinical decision support (CDS) tools, and AI/ML-enabled technologies, including validation standards and cybersecurity mandates. Speakers underscored the importance of aligning regulatory strategy with business models and offered guidance on leveraging Pre-Submission processes and breakthrough device designation to accelerate approval. Real-world insights from wearable device development illustrated the complexities of clinical validation, reimbursement planning, and risk-based regulation.You will gain practical knowledge on navigating FDA processes to responsibly develop and deploy AgeTech innovations for older adults. About the Speakers: Ameet Sarpatwari, PhD,…