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.

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 ...

This presentation provides an overview of the Quality Management System Regulation, including preamble and final rule, a review of some important definitions and their hierarchy of application, and a ...

The FDA's new Quality Management System Regulation doesn't just align American standards with global practice—it fundamentally redefines what regulators mean by 'quality.' Medical device companies ...

The FDA’s firm-based approach to regulating medical devices means that the regulatory oversight focuses on the quality systems and processes of the manufacturing firm, rather than just on the ...

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 ...

The attempt by the U.S. FDA to harmonize its Quality System Regulation (QSR) with ISO 13485 promises to be a difficult slog, but Jeff Shuren, director of the agency’s device center, said the agency is ...

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 ...

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 ...