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Regulatory Reform › Regulatory Oversight › Medical Devices

Morgan Lewis

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

Morgan Lewis on

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

Akin Gump Strauss Hauer & Feld LLP

Five FDA Takeaways from the FY26 Budget

Akin Gump Strauss Hauer & Feld LLP on

On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as...more

Ropes & Gray LLP

2025 Medtech Regulatory Affairs Roundtable: Key Takeaways

Ropes & Gray LLP on

On May 22, Ropes & Gray and McKinsey & Company co-hosted the 12th Medtech Regulatory Affairs Roundtable online. Around 40 Regulatory Affairs leaders from Chinese and multinational medtech companies gathered to review and...more

Venable LLP

Venable FDA Pulse: FDA at the 100-Day Mark of Trump Administration 2.0

Venable LLP on

Since returning to office for a second term, President Trump has taken steps to reshape federal agencies. Here, we discuss the significant changes that have occurred at the Food and Drug Administration (FDA or Agency) during...more

Mintz - Health Care Viewpoints

HHS Restructuring and Workforce Reductions – Key Implications for the Health Care Industry

Mintz - Health Care Viewpoints on

As spring arrived in the mid-Atlantic region, the Department of Health and Human Services (HHS) under Robert F. Kennedy, Jr. followed through with a previously announced Reduction in Force (RIF) that reduced the department’s...more

Jones Day

EU Geopolitical Risk Update - Key Policy & Regulatory Developments No. 119

Jones Day on

This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more

Bennett Jones LLP

Health Canada Consultation on Proposed Amendments to Address Drug and Medical Device Shortages in Canada

Bennett Jones LLP on

Health Canada is proposing to amend the Food and Drug Regulations, C.R.C., c.870 (the FDRs) and the Medical Device Regulations, SOR/98-282 (the MDRs) in an effort to avoid pharmaceutical and medical device shortages and...more

Alston & Bird

Feds Continue to Reform Approach to Regulation of Biotech Products

Alston & Bird on

Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more

Faegre Drinker Biddle & Reath LLP

FDA issues final rule clarifying its “intended use” regulations for pharmaceuticals and medical devices

Faegre Drinker Biddle & Reath LLP on

The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule...more

Hogan Lovells

Five highlights from FDA’s new AI device regulation Action Plan

Hogan Lovells on

On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based...more

Hogan Lovells

UK regulation of medical devices from 1 January 2021

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published new guidance (the "Guidance") on how medical devices will be regulated in Great Britain ("GB") (England, Wales and Scotland) and in Northern...more

Hogan Lovells

FDA loosens restrictions on gynecologic power morcellators, recommends use only with containment

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) today released significant changes to its recommendations for the use of laparoscopic power morcellators in gynecologic procedures, including an update to safety communications...more

Polsinelli

FDA Guidance on Software as Medical Devices Represents Broader Deregulation Trend

Polsinelli on

The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more

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