Tuesday, January 6, 2026, yielded two surprising updates from the Food and Drug Administration (“FDA”) Center for Devices and Radiological Health. While many experts have been forecasting continued tension between med tech innovators and the agency based on enforcement trends in 2025, FDA released two policy updates that, in fact, purport to ease the burdens on developers of certain wearables and clinical decision support (“CDS”) software tools.
Introduction
Let’s say FDA proposed a guidance document that would change the definition of “low cholesterol” for health claims. Now let’s say that when FDA finalized the guidance, instead of addressing that topic, FDA banned Beluga caviar. If you are interested in Beluga caviar, would you think you had adequate opportunity to comment? Would you care if FDA argued that Beluga caviar was high in cholesterol so the two documents were related?
Recent Updates
- DOJ, HHS Announce One-Stop Shop for Companies Voluntarily Disclosing Potential Health Care Fraud
- DOJ, HHS, CMS Launch an FCA Self-Disclosure Program for Health Care: Who Can Participate, How, and Why
- Psychedelics Move Toward the Mainstream: Lawyers’ Bird’s-Eye View from the Horizons Conference
- CMS Receives Its Exclusion Authority: What Happens Now?
- GLOBE Model Final Rule Drops — but Will It Work on a Smaller Scale?