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AI Summit panelists mull complexities of EU’s AI Act, global compliance considerations

Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including evolving regulatory...more

AI Health Law & Policy: FDA’s rapidly evolving regulatory paradigms

Artificial intelligence has become one of the most transformative forces in health care, reshaping everything from drug discovery to diagnostics. For pharmaceutical and medical device companies, AI-driven solutions present...more

State Licensing Spotlight – Medical Device Manufacturers & Distributors: Compliance Strategies for Avoiding or Reducing Penalties

Medical device manufacturers and distributors have come under increasing scrutiny from state licensing agencies and operating without a required license may lead to severe consequences. These can include financial penalties;...more

New guidance on AI-enabled device software functions clarifies information FDA expects in marketing applications

On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more

FDA lists top 10 artificial intelligence regulatory concerns

Last week, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials published a “Special Communication” in JAMA titled, “FDA Perspective on the Regulation of Artificial...more

FDA summarizes LDT rule requirements in new compliance guide

The U.S. Food and Drug Administration (FDA) announced yesterday a “Small Entity Compliance Guide” (SECG) for Laboratory Developed Tests (LDTs), aiming to assist small entities in complying with FDA’s LDT final rule, which...more

First salvo fired against FDA’s laboratory developed test rule

In the Eastern District of Texas U.S. federal court, the American Clinical Laboratory Association (ACLA) and its member company, HealthTrackRx, have filed a lawsuit against the Food and Drug Administration (FDA), claiming the...more

FDA finalizes guidance on “Remanufacturing” vs “Servicing”

The U.S. Food and Drug Administration (FDA) has finalized its guidance on “Remanufacturing of Medical Devices,” clarifying the point when manipulation or repair of a medical device becomes “remanufacturing” as opposed to...more

FDA under fire: Pared-down LDT Final Rule leaves unanswered questions

The U.S. Food and Drug Administration (FDA) has finalized its historic — and notoriously controversial — rule to explicitly assert the agency’s authority to regulate laboratory developed tests (LDTs). Below we summarize the...more

Device makers must verify third-party lab data, FDA warns

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 engage to conduct performance...more

U.S. device makers get 2 years to comply with FDA Quality Management System Regulations final rule

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) requirements for medical devices. The final rule...more

JPM2024: Manufacturing outlook for transformative technologies

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 and custom medical device...more

Informed consent duties for IRBs, investigators, and sponsors detailed in FDA final guidance

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. The final guidance supersedes FDA’s...more

The next era of digital therapeutics

Products incorporating artificial intelligence/machine learning (AI/ML) algorithms have enormous potential for health care. The power of AI can enhance the capabilities of software that has the potential to benefit more...more

FDA issues milestone draft guidance on decentralized clinical trial design & implementation

The U.S. Food and Drug Administration (FDA) has just published a highly-anticipated draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biologics, and medical devices. In the draft...more

JPM2023 Trendspotting: takeaways from Biotech Showcase

At the recent J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry led in-person discussions with industry experts on topics that will guide...more

JPM2023 Trendspotting: commercializing digital therapeutics

As the industry readies itself for the January 2023 pilgrimage to the J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry team has prepared...more

FDA to regulate more AI & software tools as devices, guidance indicates - FDA also seeks new digital health regulatory paradigm in...

In the waning days of FDA’s fiscal year, the U.S. Food and Drug Administration (FDA) issued the greatly anticipated final guidance “Clinical Decision Support Software,” which aims to clarify the scope of the FDA’s oversight...more

FDA plans to expand remote evaluations, record reviews post-pandemic

The U.S. Food and Drug Administration (FDA) recently issued draft guidance on how it will continue to conduct remote regulatory assessments (RRAs) after the COVID-19 public health emergency (PHE) ends. This guidance...more

HHS withdraws proposal to exempt 84 medical device types from FDA 510(k) process

On April 16, the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) published a notice of withdrawal of their January 15 proposal to exempt 84 medical device types ...more

Life Sciences and Health Care Horizons - 2021

Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more

HHS proposal to exempt medical devices from 510(k) process halted

On January 15, the U.S. Department of Health and Human Services (HHS) published a notice and request for information (RFI) proposing to exempt 91 medical devices – for which the normal regulatory process was temporarily...more

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

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

Looking ahead to 2021: AI – A brave new world?

In recent years, AI has become a buzzword in life sciences and health care as the technology has developed to create applications from drug discovery to diagnostics to therapeutics. Most recently, AI has been used in the...more

[Virtual Event] AI – A brave new world? - December 1st, 11:00 am - 12:15 pm EST

Life Sciences and Health Care Horizons virtual event series - The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more

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