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: ...
American Enterprise Institute

Congress Must Update FDA Regulations for Medical AI

The FDA’s firm-based approach to regulating medical devices means that the regulatory oversight focuses on the quality systems and processes of the manufacturing firm, rather than just on the ...
Fierce Healthcare

FDA advisory committee to roll up sleeves on generative AI this week

The FDA will hold its first Digital Health Advisory Committee (DHAC) meeting to discuss how the agency should review medical devices that rely on generative AI, like chatbots. The meeting will be held ...
Healthcare IT News

FDA finalizes AI-enabled medical device life cycle plan guidance

The U.S. Food and Drug Administration has announced the availability of its final guidance on AI medical devices. The document – Marketing Submission Recommendations for a Predetermined Change Control ...
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 ...
St. Louis Post-Dispatch

FDA proposes regulation of e-cigarettes

The regulations will be a step in a long process that many believe will ultimately end up being challenged in court. Kevin Gutknecht, co-owner of the e-cigarette shop Vapor Exchange in the Delmar Loop ...
MobiHealthNews

Commentary: FDA’s website has wrong information about the scope of its software regulation — and that's a big problem

The guidance sets forth FDA’s 2015 policy on when mobile medical applications qualified as medical devices. But in 2016 the 21st Century Cures Act changed fundamentally the scope of FDA’s oversight of ...
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 ...
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 ...
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

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