Nathan Brown 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

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 Debuts a New Communications and Compliance Tool for Device Data Integrity Concerns

Yesterday, the U.S. Food and Drug Administration (FDA) updated its website to provide new information on data integrity concerns relating to medical devices. Over a year ago, FDA’s device center, the Center for Devices and...more

3/13/2025 / Compliance , Data Integrity , Enforcement Actions , Food and Drug Administration (FDA) , Medical Devices , Regulatory Requirements

2025 Perspectives in Private Equity: Health Care & Life Sciences

Private equity investors in health care and life sciences must navigate a complex and shifting landscape influenced by regulatory and policy changes and technological advancements. As private equity investments in the health...more

Just Prior to Leadership Change, FDA Announces Public Workshops to Advance Dialogues on HCT Product Development and Optimizing...

In the final stretch of the Biden administration, the Food and Drug Administration (FDA) laid the groundwork for continued engagement with the public on two challenging areas of product development, each of which is of high...more

1/23/2025 / Data Collection , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Medical Devices , Medical Research , Pregnancy , Public Health , Regulatory Requirements

FDA Finalizes Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products

On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions...more

1/20/2025 / Compliance , Final Guidance , Final Rules , Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Medical Devices , OMB , Pharmaceutical Industry , Regulatory Agenda , Regulatory Reform , Regulatory Requirements

FDA Publishes a Wide Range of Guidances in the Final Days of the Biden Administration

On January 6 and 7, 2025, the FDA announced, by our count, 31 draft or final guidances, on a wide range of topics. Historically, an incoming administration will impose a temporary freeze on the issuance of guidances and...more

1/9/2025 / Artificial Intelligence , Biden Administration , Digital Health , Food and Drug Administration (FDA) , Food Safety , Life Sciences , Medical Devices , Prescription Drugs

FDA’s Idea Lab Seeks to Reimagine Device Use in the Home Through New Virtual Reality Prototype

On December 30, 2024, FDA unveiled an Idea Lab as part of its Home as a Health Care Hub initiative to reimagine how new and existing medical devices can be incorporated in a home environment. As previously discussed here, FDA...more

1/3/2025 / Food and Drug Administration (FDA) , Home Health Care , Medical Devices , Virtual Reality

FDA Finalizes PCCP Guidance for AI-Enabled Medical Devices

Today FDA issued final guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI) enabled device software functions. FDA recognizes that development of...more

12/5/2024 / Artificial Intelligence , Final Guidance , Food and Drug Administration (FDA) , Medical Devices , White Papers

Three Questions with Sedgwick’s Jeremy Schutz

In this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, recall & remediation at Sedgwick, to explore key strategies that pharmaceutical...more

12/4/2024 / Cybersecurity , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry , Quality Control Plan , Risk Management , Supply Chain

National Institutes of Health Develops AI Algorithm to Identify Potential Volunteers for Clinical Trials

Researchers from the National Institutes of Health (NIH) have developed an algorithm that harnesses AI to help accelerate the process of matching potential volunteers for relevant clinical research trials. The algorithm,...more

11/26/2024 / Algorithms , Artificial Intelligence , Bias , Clinical Trials , Diversity , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , National Institute of Health (NIH) , Patients

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

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

11/26/2024 / Corrective Actions , Federal Pilot Programs , Food and Drug Administration (FDA) , Medical Devices , Notification Requirements , Product Recalls , Public Safety

President-elect Trump Makes More HHS Personnel Moves: Dr. Marty Makary Tapped to Lead FDA

In recent days, President-elect Trump has made progress in announcing the names of various individuals he intends to nominate to serve in some of the most senior and influential leadership positions at the Department of...more

11/26/2024 / Centers for Disease Control and Prevention (CDC) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Loper Bright Enterprises v Raimondo , Medical Devices , Public Health , Trump Administration , World Health Organization

FDA Announces New Director of the Center for Devices and Radiological Health

Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Director of the Center for Devices and Radiological Health (CDRH). She has spent...more

10/24/2024 / Food and Drug Administration (FDA) , Medical Devices , Public Health , Research and Development

FDA Publishes Digital Health and Artificial Intelligence Glossary

On September 26, 2024, FDA published a compilation of commonly used terms in the digital health, artificial intelligence (AI), and machine learning space and their definitions, available here. FDA intends the glossary to be...more

10/14/2024 / Artificial Intelligence , Digital Health , Food and Drug Administration (FDA) , Machine Learning , Medical Devices

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

ONC Proposes Sweeping Health IT Certification Program Requirements for “Predictive Decision Support Interventions”—Featuring...

On April 18, 2023, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) published a far-reaching proposed rule, Health Data, Technology, and...more

5/9/2023 / Artificial Intelligence , Department of Health and Human Services (HHS) , Digital Health , Food and Drug Administration (FDA) , Health Care Providers , Machine Learning , Medical Devices , Proposed Rules

Software and Digital Health Policies Issued by FDA

Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug...more

4/6/2023 / Artificial Intelligence , Cybersecurity , Digital Health , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Machine Learning , Medical Devices

FDA Gets Digital, Agency Issues Digital Health Policies on PCCP, Cybersecurity and Drug Development

In recent days, the U.S. Food and Drug Administration (FDA) has issued multiple policy documents relating to software and digital health. Two of them relate to software-based medical devices: draft guidance for predetermined...more

4/4/2023 / De Novo Standard of Review , Digital Health , Draft Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , Pharmaceutical Industry

Congress’ Year-End Appropriations Package Brings FDA Legislative Changes, Leaves Unresolved Policy Issues

In a break with past precedent, last year’s Food and Drug Administration (FDA) user fee reauthorization legislation did not contain significant FDA policy changes. Although the Senate Health, Education, Labor and Pensions...more

1/11/2023 / Biosimilars , Consolidated Appropriations Act (CAA) , Cosmetics , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Popular

FDA Changes Direction in Final CDS Guidance

FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation - Key Points - The Final Guidance does not address the FDA’s risk-based enforcement discretion policy...more

10/5/2022 / Artificial Intelligence , Draft Guidance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , GAO , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry

FDA User Fee Reauthorization Legislation Continues to Simmer in Congress: What’s at Stake and What it Means for September

Update on UFA Reauthorization Legislation - As outlined in Akin Gump’s previous analysis, the current five-year authorization of the Food and Drug Administration (FDA) user fee programs for branded/reference drugs and...more

8/15/2022 / BsUFA , Food and Drug Administration (FDA) , GDUFA , Medical Device User Fee Program (MDUFA IV) , Medical Devices , PDUFA , User Fees

FDA User Fee Reauthorization Gains Momentum with Senate HELP Committee Approval

There continues to be no shortage of FDA-related issues in front of Congress this summer. In recent days, the pace of Congressional action on reauthorizing FDA’s user fee programs has significantly picked up with the Senate...more

6/27/2022 / Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , GAO , HELP , Imports , Medical Devices , Prescription Drugs , User Fees

Nathan Brown

Akin Gump Strauss Hauer & Feld LLP

Popular Topics by This Author

Latest Posts › Medical Devices