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Medical Devices › Public Safety

Hogan Lovells

State Licensing Spotlight – Prescription medical device manufacturers & distributors: Regulatory considerations applicable to...

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State licensing for prescription medical device manufacturers and distributors is a complex and evolving landscape. While FDA oversees federal regulations, individual states impose their own licensing requirements, which can...more

Akin Gump Strauss Hauer & Feld LLP

FDA Announces Plan to Speed Up Public Notification About Potentially High-Risk Device Recalls

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On November 21, 2024, FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot program aimed at improving public notice about potentially high‑risk medical device recalls. The pilot seeks to reduce the time...more

K&L Gates LLP

COVID-19: K&L Gates Triage: FDA Facilitates Diagnostic Testing and Heightens Public Safety Efforts Amid Outbreak

K&L Gates LLP on

In this week’s episode, Kenneth Kennedy discusses several of FDA’s strategies for helping stakeholders in the drug and medical device industry support health care providers in their fight against the COVID-19 outbreak. In...more

Spilman Thomas & Battle, PLLC

Product Lines - Toxic Torts and Products Liability Insights: Issue 4, 2019

Spilman Thomas & Battle, PLLC on

Welcome - Welcome to the fourth 2019 issue of Product Lines – our quarterly e-newsletter that focuses on toxic torts and product liability issues. For this edition, we are reporting on several important and timely legal...more

Spilman Thomas & Battle, PLLC

Product Lines - Toxic Torts and Product Liability Insights - Issue 3, 2018

Spilman Thomas & Battle, PLLC on

Welcome to the third issue of Product Lines – our quarterly e-newsletter that focuses on toxic torts and products liability issues. For this edition, we are reporting on several important and timely legal issues. As you...more

Robinson & Cole LLP

Data Privacy + Cybersecurity Insider - October 2018

Robinson & Cole LLP on

On October 1, 2018, the Food and Drug Administration (FDA) issued its “Medical Device Cybersecurity Regional Incident Preparedness and Response Playbook” to address continued threats to medical devices that could affect...more

Mintz - Health Care Viewpoints

FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Mintz - Health Care Viewpoints on

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

Knobbe Martens

FDA Proposes Ban on Electrical Stimulation Devices for Aggressive or Self-Injurious Behavior

Knobbe Martens on

On April 25, the U.S. Food and Drug Administration published a proposed rule banning electrical stimulation devices (ESDs) used to treat aggressive or self-injurious behavior....more

Mintz - Health Care Viewpoints

Acquittals in Vascular Solutions Case Deal Setback to DOJ

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On February 26, 2016, a federal jury in Texas returned not guilty verdicts with respect to charges brought against Vascular Solutions Inc. (“VSI”) and its CEO by the U.S. Department of Justice (“DOJ”), dealing a decisive blow...more

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