JD Supra

FDA updates compliance program inspection manual for the QMSR age

On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, ...
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 ...
Becker's Hospital Review

FDA sounds early alert on Abiomed heart pumps

The FDA has issued an early alert warning of a potentially high-risk issue affecting certain Abiomed heart pumps. The agency said Abiomed issued an urgent medical device correction Jan. 27 for all ...
STAT

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

Y ou’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life ...
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 ...
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.
Medical Device and Diagnostic Industry (MD+DI)

How Medical Device Companies Can Avoid Costly FDA Inspection Mistakes

Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.
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 ...

FDA Qualifies MolecuLightDX Wound Measurement as a Medical Device Development Tool (MDDT) for Evaluating New Products in Wound Care

PRNewswire/ - MolecuLight today announced that its MolecuLightDX(R) wound measurement has been qualified by the U.S. Food and Drug Administration (FDA) as a Medical Device Development Tool (MDDT). 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 ...
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 ...