Health Law Advisor

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.

FDA published the long awaited draft guidance on wellness products last Friday. The guidance is a positive step forward for industry in that it proposes that certain general wellness products will not be subject to FDA regulation.

The draft guidance clarifies that FDA does not intend to enforce its regulations against products that are "low risk" and are intended to:

1. Maintain or encourage health without reference to a disease or condition (e.g. weight, fitness, stress) or
2. Help users live well with or reduce risks of chronic conditions, where it is well accepted that a healthy ...

by Brandon C. Ge

In the months leading up to Election Day 2012, the pace of health reform implementation slowed considerably as the Obama administration held off on releasing regulations to avoid pre-election controversy. With the 2012 elections now in the books, health reform has scored two major victories: the re-election of President Barack Obama and the preservation of a Democratic majority in the Senate. Although the Affordable Care Act (ACA) is now safe from repeal, implementation still faces hurdles, such as state resistance, the fiscal cliff, and pending lawsuits ...