Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post. The U.S. Food and Drug Administration (FDA) issued the much-anticipated proposed ...

The FDA issued a final rule which continues efforts to promote consistency in the regulation of devices and provides timelier introduction of safe and effective high-quality devices for patients.

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 ...

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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 ...

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 ...

The U.S. FDA dropped the final rule for the Quality Management System Regulation (QMSR), the long-awaited blending of the agency’s own Quality System Regulation (QSR) and ISO 13485.

This (QSR) Quality System Regulation webinar describes management responsibility by reviewing the Quality System Regulation (QSR) and the reasoning that FDA published. It covers each of the components ...

The medical device industry is undergoing a significant transformation as FDA transitions from the longstanding Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR), ...

The agency said it issued the import alerts because it “continues to have concerns related to outstanding Quality System regulation violations by Olympus.” The FDA sent three warning letters to ...