RAPS

FDA Considers Shift on Device Quality System Regulations

A US Food and Drug Administration (FDA) spokeswoman told Focus on Wednesday that as part of global harmonization efforts around quality management systems, the agency is considering adding clauses ...
Hosted on MSN

An Overview of the Quality Management System Regulation

Hello. I’m Joseph Tartal, Deputy Director of the Division of Industry and Consumer Education, in the Center for Devices and Radiological Health, at the U.S. Food and Drug Administration. Welcome to ...
MassDevice

Zoll faces FDA warning letter related to quality, reporting processes

The FDA issued Zoll Medical a warning letter outlining quality system regulation violations and violations of medical device ...
MD&M East

Medtech Implementation of FDA’s Updated QMSR

Fulfilling the required changes to FDA’s quality management system regulation (QMSR) ahead of February 2026’s compliance deadline is much ado about nothing for most companies, according to Kim ...
RAPS

Upcoming FDA Rulemakings: Device Quality Systems, Post Approval Changes to NDAs and BLAs and More

The Department of Health and Human Services (HHS) on Wednesday released the spring version of its unified agenda on proposed and final rulemakings, featuring a proposed rule on quality system ...
JD Supra

A QMSR State of Mind: FDA Adopts New Inspection Approach for Medical Devices as Quality Management System Regulation Takes Effect

On February 2, 2026, FDA’s new Quality Management System Regulation (“QMSR”) for medical devices became effective, two years after FDA’s issuance of a final rule to implement the QMSR. The QMSR ...
Medical Device and Diagnostic Industry (MD+DI)

FDA Issues Warning Letter to Zoll Medical for Manufacturing Violations Involving Life-Saving Devices

FDA issued a warning letter to Zoll Medical following a 14-month inspection of its Chelmsford, Massachusetts facility.
Becker's ASC

Polymicro Technologies Achieves FDA Quality System Regulation Registration, Compliance

Polymicro Technologies, a subsidiary of Molex, announced its registration and compliance with the U.S. Food and Drug Administration 21 CFR 820 Quality System Regulation. The Polymicro Technologies ...

FDA Warning Tests Medline Quality Systems And Earnings Story

Medline (NasdaqGS:MDLN) has received a warning letter from the U.S. FDA citing significant repeated violations of current Good Manufacturing Practice regulations. The letter focuses on recurring ...
JD Supra

FDA readies for QMSR implementation with draft QMS information guidance: What manufacturers need to know

FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed to prepare industry for the February 2, 2026 effective ...
Dark Reading

FDA's Critical Role in Keeping Medical Devices Secure

The Internet and the always connected world have significantly improved medical care with devices that can transmit patient data in real-time to caregivers. But with this growing reliance on software ...