2024年1月31日，美国FDA发布最终规则，对实施近30年的质量体系法规（QS Regulation）进行重大修订，将21 CFR 820更名为 质量管理体系法规（QMSR） ，并通过"引用并入"方式将 ISO 13485:2016 国际标准正式纳入美国监管体系。这一历史性变革将于 2026年2月2日 正式生效，标志着美国医疗器械监管正式与全球标准接轨。

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 ...

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 ...

The US Food and Drug Administration (FDA) published its Medical Devices; Quality System Regulation Amendments proposed rule to amend the medical device Quality System Regulation (QSR) on February 23, ...

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 ...

The U.S. FDA’s Jan. 14 webinar for the new Quality Management System Regulation included some fairly predictable content, but one member of the FDA staff mentioned that the agency now expects ...

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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 ...

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 ...