On February 11, 2026, the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) held a Town Hall to address industry questions and provide further clarity on the January 6, 2026, update...more
Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision support (“CDS”) software and general wellness products provide clearer, more...more
On January 6, 2026, the US Food and Drug Administration (FDA) issued two revised guidance documents relating to general wellness products (General Wellness Guidance) and clinical decision support software (CDS Software...more
On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical Decision Support Software (“Revised CDS Guidance”) and its General Wellness Policy for Low Risk Devices...more
The United States Food and Drug Administration (FDA) issued revisions this month to its guidance documents "Clinical Decision Support Software" (CDS Guidance) and "General Wellness: Policy for Low Risk Devices" (General...more
Last week, the U.S. Food and Drug Administration (“FDA”) rung in the new year with a flurry of device-related activity, updating two final guidance documents and withdrawing a guidance published back in 2017. The two final...more
Since 2019, companies that offer software and/or hardware devices aimed at promoting consumer health and wellness have had little more to rely on than a single short U.S. Food and Drug Administration (FDA) guidance document...more
As Americans kick off the new year with resolutions to get fit, sleep better, and take better care of themselves, the FDA has broadened access to the wearable wellness device market to a greater number of products. In a...more
The FDA’s January 2026 update to its “General Wellness: Policy for Low Risk Devices” guidance materially expands the types of wearable features that may avoid medical device regulation. Signaling a more flexible regulatory...more
On January 6, the Food and Drug Administration (FDA) updated its guidance documents on Clinical Decision Support (CDS) software and general wellness products, and withdrew its guidance on the adoption of international...more
The world of wearable health technology has exploded in the last decade, driven by consumer demand for tools to monitor health, track fitness and provide personalized insights into overall wellness. This increased demand has...more
The surge in health and wellness devices—including wearables, beauty devices and more—comes a result of consumer interest in preventive health measures. These products offer a range of benefits, from improving skin and...more
Host Mary O'Brien interviews Wilson Sonsini partner Paul Gadiock exploring the convergence of the gaming and healthcare industries....more
In this issue, we discuss U.S. Food and Drug Administration (FDA) regulation of wellness devices. We also look at good commercial contracting hygiene for digital health start-ups. Other articles include recent enforcement...more
On Thursday, January 30, members of Verrill’s Labor & Employment Group and Employee Benefits & Executive Compensation Group conducted a full-day seminar on employment law topics to prepare HR professionals, managers, and...more
The enactment of the 21st Century Cures Act signaled the close of a multi-year bipartisan effort on Capitol Hill to grant the US Food and Drug Administration (FDA) new authorities to expedite product development and reform...more
The Agency shows no signs of slowing regulatory activity. Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
The Food and Drug Administration has issued guidance on general wellness products, which are low risk products it will not regulate as “medical devices.” A draft of the guidance was issued in January 2015, and the final...more
The Food and Drug Administration Safety Innovation Act of 2012 (“FDASIA”) required a collaborative effort by the Food and Drug Administration (“FDA”), Federal Communications Commission and Office of the National Coordinator...more
The U.S. Food and Drug Administration (FDA) recently released final version of its guidance, General Wellness: Policy for Low-Risk Devices (Policy), with a webinar slated for September 1st as part of the rollout. While not...more
On July 29, 2016, the US Food and Drug Administration (FDA) finalized General Wellness: Policy for Low Risk Devices Guidance (Final Guidance) detailing its risk-based regulatory approach to relax certain regulatory...more