What are Mobile Mental Health Apps and How Are the Apps Regulated? Part Two
What mobile mental health app manufacturers and the physicians who recommend and use these apps need to understand about FDA regulation of medical devices.
Digital Health and FDA – Part One
The FDA does have authority to regulate medical devices – including digital health technologies that qualify as medical devices. Digital health includes SaMD, AI, ML, medical mobile apps, and [...]
Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Part Two
Key provisions of the FDA’s proposed regulatory framework of software that uses and adapts to artificial intelligence and machine learning
