JD Supra

The QMSR Goes Live and FDA Implements a New Medical Device Inspection Technique

On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice ...
MedTech Dive

FDA guidance eases wearables oversight. But experts have questions about what’s next.

Experts say two new guidances — issued without the usual public comment period — leave questions about how patients will ...
STAT

AI doctors are coming. Should FDA make sure they’re safe?

Despite it all, I’m feeling sunny today because the temperature popped above freezing yesterday. Bring it on, February. In this edition: I take a closer look at Doctronic’s hyped “AI doctor” ...
JD Supra

What FDA’s TEMPO Pilot and CMS’s ACCESS Model Mean for Medical Device Manufacturers

The U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) have launched two coordinated initiatives: the ...
NBC New York

FDA moves to rehire medical device staffers fired only days earlier

Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning Friday night, FDA ...
Becker's Hospital Review

Device supply gaps put pediatric patients at risk: FDA

Device supply gaps put pediatric patients at risk by causing delays and forcing use of adult equipment, FDA says in recent safety alert.
Yahoo

FDA moves to rehire medical device, food safety and other staffers fired days earlier

WASHINGTON (AP) — Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning ...
Penn Live

FDA rehires medical device staffers fired only days earlier

WASHINGTON (AP) — Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning ...