ARTICLE SUMMARY:
In this week’s Pathways Picks: FDA expands the scope of software and wearable products it doesn’t need to review and withdraws a global software guidance; notes from ongoing user fee talks; updates from China, Europe, Saudi Arabia, Brazil, and IMDRF; and dates to remember.
Digital Deregulation at FDA
Decision support, wellness guides reworked, and more:
Loosening software, wearables oversight. FDA published updates to its clinical decision support (CDS) software and general wellness guidelines January 6, opening the door for more digital health products to reach the market without agency review. The guides were revised without standard draft-and-comment periods. It’s anticipated the changes will result in more risk-prediction software and non-invasive sensors, among other categories, bypassing FDA regulation.
Decision-support changes. Under the 2022 version of the CDS guidance, software that provided recommendations not intended to replace a clinician’s judgements qualifies under federal law as a non-regulated product, but if the software provided a specific output or directive, it’s a regulated medical device. In the updated version, however, FDA says it will not enforce regulation for software that provides a specific output when “only one option is clinically appropriate.” The update also expands what qualifies as the type of “medical information” that software can display, analyze, or print and remain unregulated. Further, it tightens the definition of what constitutes a “pattern” of measurements taken by software that would designate it as a regulated device.
Wellness wearable path. The general wellness guide, originally published in 2019, describes products that are considered low-risk and unregulated under federal law because they are simply intended to maintain or encourage a “healthy lifestyle.” The main revision to the document establishes a new path for non-invasive sensors, such as wearable monitors for blood pressure, glucose, heart rate, or other parameters to be designated low-risk general wellness products if they meet certain stipulations. “There's now a clear lane for consumer-grade products and a clear lane for medical-grade products,” said FDA Commissioner Marty Makary, MD, during January 6 remarks at the CES 2026 conference in Las Vegas. “If you're not making medical or clinical claims, you don't need to come through the FDA.” The updated guidance underscores, that to be exempted, a device can’t report values that “mimic those used clinically unless validated … to reflect those values.”
Some observers said the guidance revisions will have major impacts, while others are predicting more measured practical implications. “If you’ve been watching industry commentary, you’d think the agency redrew the entire digital health map overnight. I don’t see it that way,” wrote Yujan Shrestha, MD, a digital health expert and consultant, in a January 8 analysis. “There are a couple of places where policy actually moved, but not nearly as much as the hype suggests.”
