Michael Chen
Regulatory pathways for digital health have evolved significantly over the past decade. What started as a challenge—how to regulate software that can be updated continuously—has become an opportunity for innovative companies.
FDA's Evolving Approach
The FDA has recognized that traditional medical device regulation doesn't perfectly fit digital health products. The agency has created new pathways, including the Software Precertification Program and streamlined processes for low-risk digital therapeutics.
"Regulation shouldn't be a barrier to innovation—it should be a framework that ensures safety while enabling progress."
Companies that understand these pathways and can navigate them efficiently have a significant competitive advantage. Early engagement with regulatory bodies, clear evidence generation strategies, and thoughtful risk assessments are critical.
International Considerations
The regulatory landscape varies significantly across markets. What works in the United States may need adaptation for European markets, and vice versa. Successful companies build regulatory strategy into their product development from day one.