Regulatory Standards, Medical Devices, Federal Food Drug and Cosmetic Act (FFDCA)

FDA Needs a New Approach to AI/ML-Enabled Medical Devices

Mintz - Health Care Viewpoints on 3/13/2024

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...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

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on 1/4/2024

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

The Omnibus Appropriations Act Grants FDA Formal Authority to Require Cybersecurity Action by Medical Device Manufacturers

Faegre Drinker Biddle & Reath LLP on 2/21/2023

Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show...more

FDA Proposes Amendments to Medical Device Quality System Regulation

Skadden, Arps, Slate, Meagher & Flom LLP on 3/2/2022

On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good manufacturing practice...more

FDA Policy for Mobile Medical Applications

Nossaman LLP on 2/18/2020

The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify...more

Parsing products: FDA regulatory policy for multi-function medical devices

Hogan Lovells on 5/7/2018

On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's regulatory approach to medical...more

Third Circuit Issues Precedential Ruling on Express Preemption for Hybrid Medical Devices

Cozen O'Connor on 3/21/2018

The Third Circuit has become the first U.S. Court of Appeals to address the application of the express preemption provision in the Medical Device Amendments of 1976 to hybrid medical devices. Hybrid medical devices are...more

Third Circuit Grants Express Preemption in “Hybrid” Medical Device Case

Bradley Arant Boult Cummings LLP on 3/7/2018

On March 1, the U.S. Court of Appeals for the Third Circuit, in Shuker et al. v. Smith & Nephew PLC, affirmed a District Court’s ruling that claims against a medical device manufacturer are expressly preempted by federal law....more

Regulatory Standards › Medical Devices › Federal Food Drug and Cosmetic Act (FFDCA)

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