Health Law Advisor

The Food and Drug Administration (FDA) is urging innovators, providers, and patients to “reimagine the home as an integral part of the health care system.” If you’re skeptical, the “Home as a Health Care Hub” initiative was introduced in 2024 by the FDA’s Center for Devices and Radiological Health (CDRH) in response to changing needs of health care and feedback from the public, accelerated by the COVID-19 pandemic.

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.

This month I wanted to take a data-driven look at FDA’s treatment of citizen petitions, and specifically as a starting point how quickly the agency resolves those petitions.  Make no mistake, I have an interest in this topic.  Over the more than 35 years I have been practicing law, I have filed multiple petitions including a 1995 petition that successfully caused FDA to adopt Good Guidance Practices.  But more recently, specifically on February 6, 2023, I filed a citizen petition asking FDA to rescind its final guidance on Clinical Decision Support Software.[1]  On August 5, 2023, when we ...