By nature, digital health innovation is pushing the envelope, often operating in a gray zone where regulatory requirements may be unclear. However, with a dedicated center of excellence, new guidances, and a policy navigator, the FDA is taking action to provide clarity. As the FDA’s regulation of digital health matures, regulatory choices will become an increasingly crucial element of go-to-market strategy. FDA regulation is a key avenue for demonstrating the validity and efficacy of digital health tools.
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