News & Analysis as of September 18, 2024

Medical Devices

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The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on 4/1/2024

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

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

King & Spalding on 2/9/2024

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

The Wait is Over: FDA Releases Proposed Rule to Align the U.S. Medical Device Quality Regulation with International Standards

King & Spalding on 3/2/2022

On February 23, 2022, the U.S. Food and Drug Administration (FDA) published in the Federal Register, 87 Fed. Reg. 10119, the long-awaited proposed rule, Medical Devices; Quality System Regulation Amendments (Docket No....more

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European Union › Proposed Rules › Medical Devices

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

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

The Wait is Over: FDA Releases Proposed Rule to Align the U.S. Medical Device Quality Regulation with International Standards

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