JD Supra

FDA Issues Long-Awaited Quality System Regulation Amendments

After four long years and a series of delays, the US Food and Drug Administration released its proposed rule for amending the Quality System Regulation to be harmonized with ISO 13485:2016. In a ...
JD Supra

FDA Aligns U.S. Medical Device Quality System Regulation with International Standards

On February 2, 2024, the U.S. Food and Drug Administration (FDA) published a final rule 1 amending the device good manufacturing practice (GMP) requirements of the Quality System Regulation (QSR) 2 ...
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 ...
BioWorld

US FDA sees new QMSR as part of push toward culture of quality

The U.S. FDA’s device center has been prodding industry for some time to develop a culture of quality regarding the manufacture of medical devices, an emphasis that has resulted in the development of ...
The National Law Review

FDA Finalizes Revised Medical Device Quality System Requirements, Issues Remote Regulatory Assessments Guidance

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
Becker's Hospital Review

Hospitals May Face FDA Inspections for Medical Device Data Systems Regulation

Hospitals that are considered device manufacturers under the new medical device data system regulation may be subject to FDA inspections, according to an Association for the Advancement of Medical ...
Business Insider

Integra LifeSciences reports FDA warning letter related to quality system issues

In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the U.S. FDA. The warning letter relates to quality system ...
BioWorld

FDA renews plan to align quality management rules with ISO standard

The FDA’s multiyear effort to rewrite the Quality System Regulation (QSR) to align with ISO 13485 could significantly ease the regulatory burden for device makers in multiple markets, but that effort ...
The National Law Review

Quality System Harmonization Is Here, But with Small Benefit to Device Industry

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
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 ...
MD&M East

Olympus Gets on FDA's Bad Side

FDA alerted healthcare providers this week about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems and its subsidiaries. “Despite extensive and ongoing efforts ...