As a former pilot participant for FDA Digital Health Pre-Check Program, I applaud FDA’s recent efforts to streamline how it regulates software through the exploration of new paradigms, as various industries (medical devices, biotech, hi-tech/software) converge to develop a wide-range of healthcare software products such as SaMD (Software as a Medical Device), mobile (medical) apps, medtech applications, CDS (Clinical Decision Support), HealthIT and bioinformatics, and technologies such as artificial intelligence, machine learning and cloud. It’s one-of-a-kind (if not once-in-a-lifetime) opportunity, both for the FDA and industry alike, to work together in developing a framework which promotes innovation while ensuring regulatory compliance.

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