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 ...
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.
JD Supra

New device QMSR includes significant changes for combination products

The new Quality Management System Regulation (QMSR) that became effective on February 2, 2026, includes significant changes ...
Chicago Tribune

Nearly 2,000 drug manufacturing plants are overdue for FDA inspections after COVID delays, AP finds

WASHINGTON — Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections ...