Caroline Kessler on Medical Devices

FDA Announces AI Councils Amid Calls for Greater Agency Transparency

Recently, it was reported that the U.S. Food and Drug Administration (FDA) is launching two cross-agency artificial intelligence (AI) councils. One AI council will be tasked with addressing how the agency uses AI internally...more

7/17/2025 / Artificial Intelligence , Data Security , Food and Drug Administration (FDA) , Healthcare , Medical Devices , Regulatory Oversight , Technology , Transparency

HHS to Launch Campaign Promoting Wearable Devices

On June 24, 2025, in a hearing before the U.S. House of Representatives Committee on Energy and Commerce, the Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr. revealed that his department plans to soon...more

6/27/2025 / Advertising , Data Privacy , Data Protection , Department of Health and Human Services (HHS) , Digital Health , Food and Drug Administration (FDA) , Healthcare Reform , Medical Devices , Public Health , Wearable Technology

No Appeal of LDT Decision Means Ball Is Back in FDA’s Court for Policy Clarification

Over the weekend, the Department of Justice (DOJ) did not file an appeal of the U.S. District Court for the Eastern District of Texas’ decision to vacate and set aside the agency’s final rule on the regulation of laboratory...more

6/6/2025 / Appeals , Department of Justice (DOJ) , Final Rules , Food and Drug Administration (FDA) , Judicial Authority , Medical Devices , Regulatory Agenda , Regulatory Requirements , Rulemaking Process

Five FDA Takeaways from the FY26 Budget

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

6/3/2025 / Department of Health and Human Services (HHS) , Drug Pricing , Federal Budget , Food and Drug Administration (FDA) , Government Agencies , Healthcare , Medical Devices , Regulatory Oversight , Regulatory Reform , Trump Administration

District Court Vacates FDA LDT Rule; What’s Next for Regulation of Lab Testing?

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets...more

4/4/2025 / Appeals , Clinical Laboratories , Final Rules , Food and Drug Administration (FDA) , Healthcare , Judicial Authority , Laboratory Developed Tests , Medical Devices , Regulatory Oversight , Regulatory Requirements

FDA’s Proposed Rule on Laboratory Developed Tests: One Small Change to Regulatory Language That Would Mark a Giant Leap in Lab...

On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more

10/6/2023 / CLIA , Emergency Use Authorization (EUA) , Enforcement , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices , Proposed Rules , Public Health , Rulemaking Process

Senate HELP Committee Unveils Draft FDA User Fee Reauthorization Legislation, with Major Reforms to In Vitro Diagnostics,...

On May 17 the Senate Health, Education, Labor and Pensions (HELP) Committee released a bipartisan legislative discussion draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA), which...more

5/24/2022 / Biologics , Biosimilars , Food and Drug Administration (FDA) , GDUFA , Generic Drugs , Medical Devices , PDUFA , Prescription Drugs , User Fees

FDA Preparedness Reforms Come into Focus as the PREVENT Pandemics Act Advances in the Senate HELP Committee

Last month, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 20 to 2 to advance S. 3799, the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (the “PREVENT Pandemics...more

4/20/2022 / Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , HELP , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry , Supply Chain

Diagnostics Reform Heats Back Up with Introduction of the Verifying Accurate Leading-edge IVCT Development Act of 2021

In vitro diagnostics (IVD) reform re-entered the legislative fray this week. The Verifying Accurate Leading-edge IVCT Development Act of 2021 (the “VALID Act of 2021,” the “VALID Act” or the “Act”) was introduced in both the...more

6/25/2021 / Clinical Laboratories , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Diagnostic Tests , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Laboratory Developed Tests , Medical Devices , Public Health Emergency

The Health Care Industry and the CARES Act: Insight and Next Steps

While the United States now leads the world with the number of reported cases of COVID-19, the Coronavirus Aid, Relief, and Economic Security (CARES) Act (or “the Act”) takes major, though perhaps still incomplete, steps...more

4/1/2020 / CARES Act , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Financial Stimulus , Health Care Providers , Hospitals , Medical Devices , Medical Supplies , Medical Testing , Over The Counter Drugs (OTC) , Personal Protective Equipment , Pharmaceutical Industry , Relief Measures

Caroline Kessler

Akin Gump Strauss Hauer & Feld LLP

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