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FDA Advisory Committee outlines informed consent best practices

The U.S. Food and Drug Administration (FDA) recently held a Patient Engagement Advisory Committee meeting focused on clinical trial informed consent practices. Below, we summarize key takeaways from the meeting, including a...more

FDA proposal classifying wound dressings/washes with antimicrobials may require PMAs, new 510(k)s

Last week, the U.S. Food and Drug Administration (FDA) proposed two new rules for classification of certain, previously unclassified wound dressings and liquid wound washes containing antimicrobials, which would categorize...more

MedTech 2023: Key takeaways from conversations on women’s health, antitrust, and AI

AdvaMed recently hosted its annual MedTech Conference in Anaheim, California, at which Hogan Lovells lawyers and regulatory specialists convened with business leaders, scientists, investors, regulators, and others across the...more

FDA approving more Deep Brain Stimulation and Transcranial Magnetic Stimulation devices

While devices that stimulate the brain invasively have generally been available since 2002, and devices that do so non-invasively have been available since 2013, in recent years, the U.S. Food and Drug Administration (FDA)...more

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