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Podcast: Talking the cure
11 April 2024
Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover...
Publications
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Device makers must verify third-party lab data, FDA warns
26 February 2024
On Tuesday, the U.S. Food and Drug Administration (FDA) issued a letter warning medical device manufacturers and sponsors of device studies to carefully evaluate the third parties that they ...
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U.S. device makers get 2 years to comply with FDA Quality Management System Regulations final rule
06 February 2024
The U.S. Food and Drug Administration (FDA) published its long-awaited final rule to amend the Quality System Regulation’s (QSR’s) current good manufacturing practice (CGMP)...
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JPM2024: Manufacturing outlook for transformative technologies
04 January 2024
Cell, tissue, and gene therapies (CTGT) have for years offered the potential for truly personalized medicine for many near-incurable disease indications. In addition, radiopharmaceuticals...
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MedTech 2023: Key takeaways from conversations on women’s health, antitrust, and AI
17 November 2023
AdvaMed recently hosted its annual MedTech Conference in Anaheim, California, at which Hogan Lovells lawyers and regulatory specialists convened with business leaders, scientists,...
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Informed consent duties for IRBs, investigators, and sponsors detailed in FDA final guidance
02 November 2023
Nine years after the draft version was published, the Food and Drug Administration (FDA) has finalized its guidance on informed consent for sponsors, institutions, IRBs, and investigators....
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Post-COVID, FDA still permits changes to non-invasive remote monitoring devices without 510(k)
23 October 2023
The U.S. Food and Drug Administration (FDA) has revised its guidance on non-invasive remote monitoring devices used to support at-home patient monitoring, replacing its March 2020 guidance...
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FCC proposes a new cybersecurity labeling program for Internet of Things devices*
12 October 2023
The Federal Communications Commission (FCC) has proposed a new voluntary cybersecurity labeling program intended to provide consumers easily understandable information about the security of ...
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U.S. FDA: labeling guidance for sponsors incorporating prescription drug use-related software
05 October 2023
The U.S. Food and Drug Administration (FDA) published new draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software” (PDS Guidance), which...
