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Executive Orders Medical Devices

Axinn, Veltrop & Harkrider LLP

Reflections on the 12th Annual Summit for Women Leaders in Life Sciences Law

We closed out July 2025 in Boston alongside several of our Axinn colleagues attending the American Conference Institute’s 12th Annual Summit for Women Leaders in Life Sciences Law. This conference is a highlight for us every...more

Quarles & Brady LLP

Risks and Regulations with the Use of AI in Behavioral Health

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As some studies estimate that nearly 23% of the adult population lives with a mental illness, the integration of artificial intelligence (AI) into mental health care has transformative potential in terms of accessibility,...more

Goldberg Segalla

Does EtO’s Recent Regulatory Battle Victory Mean It Will Win the War?

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Following years of heightened concern about the dangers of exposure to ethylene oxide (EtO), increased regulatory oversight, and a steady hum of litigation, in 2025 it seems like things might be changing for the beleaguered...more

Akin Gump Strauss Hauer & Feld LLP

Regulatory Relief for Certain Stationary Sources to Promote American Security with Respect to Sterile Medical Equipment (Trump EO...

This proclamation addresses the EPA’s April 5, 2024 final rule, National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review, 89...more

Morgan Lewis

Navigating Uncertainty in US FDA’s Center for Devices and Radiological Health Regulation of Medical Devices

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The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more

Morgan Lewis - As Prescribed

Navigating FDA’s Evolving Approach to Guidance Publication for Medical Products

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

Alston & Bird

Health Care Week in Review | Trump Administration Releases FY 2026 Budget Proposal; CMS Launches Oversight Initiative on Medicaid...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Skadden, Arps, Slate, Meagher & Flom LLP

A 20-Minute Speech Provides the Clearest Road Map Yet for FDA Policy

Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more

Alston & Bird

Health Care Week in Review | White House Issues Executive Orders on Biosecurity and Domestic Drug Production; House Committee...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Faegre Drinker Biddle & Reath LLP

The Effects of HHS Workforce Reductions, Tariffs on Pharma, the ‘Pill Penalty’ and More

With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA at the Start of the Trump Administration: A Cheat Sheet

There has been a flurry of activity at the Food and Drug Administration (FDA) since the start of the Trump administration. Day-to-day operations at FDA are already significantly altered, and we expect the trickle-down effects...more

Morgan Lewis

How New Executive Orders May Affect FDA’s Medical Device Operations

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Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration (FDA) and its regulatory oversight for medical device and digital health...more

Ropes & Gray LLP

FDA Finalizes Guidance on Predetermined Change Control Plans for AI-Enabled Medical Device Software

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On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software...more

Goodwin

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

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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

Ankura

FDA Authorized to Establish New Cybersecurity Standards for Medical Devices: What it Means for Industry

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On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more

Alston & Bird

FDA Extends Pause on Non-mission-critical Domestic Surveillance inspections to February 4 – Medical Products Supply Chain Week in...

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In this week’s issue, OSHA withdrew its emergency temporary standard (ETS), which required a mandatory vaccination policy for large private employers with an exception for employers that adopt a policy requiring mandatory...more

Sheppard Mullin Richter & Hampton LLP

“Buy American” Update: Essential Medicines May Continue to Come From Abroad (For Now)

The Biden Administration has taken (at least temporarily) the teeth out of a Trump-era Executive Order that directed the government to “Buy American” for essential drugs and medical devices. President Trump’s August 2020...more

Sheppard Mullin Richter & Hampton LLP

“Buy American” Update: FDA Issues List Of Essential Medicines Required By Executive Order

On October 30, 2020 the FDA published a list of essential medicines, medical countermeasures, and critical inputs as required by President Trump’s August 2020 Executive Order on Ensuring Essential Medicines, Medical...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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Tuesday, 20 October 2020 - President Trump’s executive order on essential medicines aims to encourage pharmaceutical companies to bring their manufacturing back to the U.S. But it may also have unintended consequences for...more

Saul Ewing LLP

CMS Proposes Medicare Coverage of Certain New Medical Devices, Clarification of “Reasonable and Necessary” Definition

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On September 1, 2020, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register a proposed rule that, if finalized, would establish a Medicare coverage pathway to provide Medicare beneficiaries with...more

Wilson Sonsini Goodrich & Rosati

CMS Proposes Basic Changes for Medicare Coverage, Including a New Reimbursement Pathway for FDA-designated Breakthrough Medical...

On August 31, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that, if finalized, would entail changes in Medicare coverage. (“Medicare Coverage of Innovative Technology (MCIT) and Definition...more

Foley & Lardner LLP

What You Need to Know about President Trump’s Executive Order to Strengthen the Domestic Supply Chain for Essential Drugs and...

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On August 6, 2020, President Trump signed an Executive Order (“Order”) to ensure essential medicines, medical countermeasures, and critical inputs are made in the United States. The President recognized that reliable...more

Hogan Lovells

Buy American EO applies domestic preferences for "essential medicines" and "medical countermeasures"

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On August 6, 2020, U.S. President Donald Trump issued his much-anticipated "Buy American" Executive Order (EO), intended to increase and support domestic manufacture and Federal government procurement of "essential...more

Spilman Thomas & Battle, PLLC

The “Preventing Essential Medical Device Shortages Act of 2020”: COVID-19 Side Effect that Could Permanently Harm Medical Device...

The ongoing COVID-19 pandemic crisis—infecting more than 2.7 million people worldwide, with almost 870,000 cases in the United States alone as of the writing of this article—has thrown nearly every industry into chaos as the...more

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