Resources
for You and Your Team
When does AI Health Software Become an FDA Regulated Medical Device? Lessons from WHOOP and UpDoc
Does adding AI to healthcare software automatically trigger FDA regulation? Not necessarily. This article examines the FDA's 2026 WHOOP closeout letter and UpDoc's 510(k) clearance to explain how the agency evaluates AI-enabled digital health products based on intended use, clinical risk, software functionality, user interface design, and validation—not simply the use of artificial intelligence. HealthTech founders, software developers, investors, and regulatory professionals will gain practical guidance on FDA General Wellness enforcement discretion, Software as a Medical Device (SaMD), AI governance, and product design strategies that can influence whether software remains a wellness product or becomes an FDA-regulated medical device.
FDA Relaxes Clinical Decision Support and General Wellness Guidance: What It Means for Generative AI and Consumer Wearables
In January 2026, FDA issued major updates to its Clinical Decision Support and General Wellness guidance, signaling a more innovation-friendly approach to generative AI, clinical copilots, and consumer wearables. This post explains what changed, which AI tools can now remain outside FDA regulation, and how digital health companies can design for compliance while accelerating time to market.
FDA Cracks Down on Wearable Devices: Lessons from WHOOP and Dexcom Enforcement Actions
Recent FDA actions against WHOOP and Dexcom reveal how wearables and SaMD are being regulated more aggressively. Here’s what digital health founders must know.