STAT

FDA digital advisers confront risks of therapy chatbots, weigh possible regulation

FDA's digital advisors could nudge the agency to clarify how its rules apply to medical applications of generative AI, including therapy chatbots.
JD Supra

From Vulnerability to Violation: FDA Cybersecurity Requirements for Medical Devices and FCA Enforcement

In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: ...
STAT

What’s FDA plotting for therapy chatbot regulation?

The Food and Drug Administration is considering whether and how to regulate therapy chatbots that are based on large language models. Today, the agency’s Digital Health Advisory Committee is meeting ...
JD Supra

Drug and Medical Device Regulation Under the Trump Administration

Many of President Trump’s executive orders (EOs) and legislative measures have been designed to curtail federal regulation, reduce the size of the administrative state, and withdraw the U.S. from ...
FierceBiotech

Federal judge blocks FDA's regulation of lab-developed tests

A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses to oversee other in vitro diagnostics and medical devices—saying the agency ...
Medical Device Network on MSN

FDA hits Philips with warning over manufacturing site deficiencies

In a letter to Philips’ CEO, the FDA cited quality system issues at three of Philips’ manufacturing sites, and failures over ...

Mobile Medical Device Apps and the FDA Training Webinar: Classification, Regulatory Requirements and Cybersecurity

The burgeoning field of Software as a Medical Device (SaMD) offers opportunities for innovation in healthcare monitoring and delivery through mobile apps. Regulatory focus by the FDA on "device ...
MobiHealthNews

Q&A: What FDA layoffs mean for MedTech approvals

Mass layoffs at the U.S. Department of Health and Human Services (HHS), including the Food and Drug Administration (FDA), will impact the medical device regulatory process, says Ben Wolf, partner in ...

Philips Had Received Warning Letter From FDA on Medical Device Facilities

The letter, dated Sept. 9, was issued by the Center for Devices and Radiological Health. It follows inspections of Philips Ultrasound facilities in Bothell, Wash. and Reedsville, Pa., as well as a ...
The National Law Review

District Court Strikes Down FDA’s LDT Rule, Opens the Door for Challenges to FDA’s Regulation of Other “Services” as Medical Devices

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...