FDA Town Hall with Dr. Michelle Tarver

April 21, 2026

Medical Alley is honored to host a landmark event for our ecosystem. For the first time in over 15 years, the FDA is returning to Minnesota for a dedicated Town Hall, and registration is now officially open for Medical Alley partners.

This is a rare and vital forum to hear directly from Dr. Michelle Tarver, Director of the CDRH, and other key agency leaders. More importantly, it is a direct opportunity for those FDA leaders and policymakers to hear from you.

Your insights are essential to this dialogue. This session is designed for the Minnesota health and life sciences to provide candid input on what is working well and to identify areas where regulatory frameworks can be strengthened to better support innovation and public health.

Event Details:

  • Date:  April 21, 2026
  • Time: 1:30–5:00 PM
  • Location: Medtronic Campus, Mounds View, MN
  • Eligibility:  Medical Alley Partners

Agenda:

  • Registration: 1:30–2:00 PM
  • Speakers: 2:00–4:00 PM
  • Reception: 4:00–5:00 PM

                   ---------------------------------------------------

  • A CDRH update by Dr. Tarver and senior staff.
  • A Fireside Chat. Dr. Tarver and her staff will respond to questions from participants. 
  • A Listening Session. The participants will move into three breakout sessions dependent upon their individual interests will have real time discussions. The purpose of the Listening Session is to provide opportunities for the FDA to hear directly from stakeholders in the health care ecosystem. Each breakout session will be led by senior FDA staff, and Dr. Tarver will rotate among the three sessions. The topics of the breakouts will include:
    Compliance and Quality
    Digital Health
    Regulatory and Clinical

Speakers

Michelle E. Tarver, M.D., Ph.D.

Director, Center for Devices and Radiological Health

U.S. Food and Drug Administration

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.  She has spent more than 15 years as a medical device regulator, driving strategic initiatives, conducting clinical research, and changing organizational culture.  Dr. Tarver has held various leadership positions while at FDA, including the Deputy Director of the Office of Strategic Partnerships and Technology Innovation and the Program Director of Patient Science and Engagement.  Over the course of her career, she has conducted laboratory-based and epidemiological studies, clinical trials, and surveys to capture patient preferences, as well as developed registries and patient-reported outcome measures. Dr. Tarver has extensive policy experience in crafting regulations, guidances, and conducting premarket and postmarket reviews. She most recently served as the Deputy Center Director for Transformation, steering the development, implementation, and direction of CDRH’s transformative projects and strategic initiatives. Under her leadership, CDRH has launched efforts to amplify the perspectives of people living with medical conditions, foster collaboration across the healthcare ecosystem, and stimulate creative evidence generation pathways.  Dr. Tarver received a B.S. in Biochemistry from Spelman College in Atlanta, GA and completed the M.D./Ph.D. program at The Johns Hopkins University School of Medicine and Bloomberg School of Public Health.  As a dedicated clinician, she continues to care for people living with inflammatory eye conditions.


Dr. Rick Abramson, MD, MHCDS, FACR

Associate Director for Digital Health, and Director Digital Health Center of Excellence

CDRH at the U.S. Food and Drug Administration 

Dr. Rick Abramson is Associate Director for Digital Health and Director of the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA).  In this role, he leads efforts to advance the development, evaluation, and regulation of digital health technologies, including artificial intelligence and software-based medical devices.

Dr. Abramson is a physician-executive with more than 20 years of experience at the intersection of healthcare delivery, technology, and policy.  Prior to joining FDA, he served as Global Chief Medical Officer at Annalise-AI, where he led global clinical and regulatory strategy.  He previously held senior leadership roles at Covera Health and HCA Healthcare.

Earlier in his career, Dr. Abramson was Associate Professor and Vice Chair for Innovation at Vanderbilt University Medical Center, where he practiced clinically and led NIH-funded research into machine learning and quantitative biomarkers for clinical trials.  He has also held roles in health policy and strategy at McKinsey & Company, the White House Office of Management and Budget, and Avalere.

Dr. Abramson received his undergraduate and medical degrees from Harvard University and a Master of Health Care Delivery Science from Dartmouth College.  He completed his postgraduate medical training at Brigham and Women’s Hospital, the University of Pennsylvania, and Johns Hopkins Hospital.  He is a Fellow of the American College of Radiology and has authored more than 80 peer-reviewed publications in medical imaging, healthcare quality measurement, and artificial intelligence.

Angela Krueger

Deputy Director for Regulatory Policy Office of Product Evaluation and Quality

U.S. Food and Drug Administration/ CDRH

Ms. Angela Krueger serves as the Deputy Director for Regulatory Policy for the Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA). In this position, she provides executive leadership of OPEQ’s total product lifecycle (TPLC) evaluation of medical devices with a focus on regulatory policy issues. Ms. Krueger provides oversight and strategic direction for OPEQ’s policy, guidance, and regulation development and implementation teams, including in areas such as digital health, combination products, and device-specific policy. Ms. Krueger has worked at the FDA for over 20 years and has previously served in the former Office of Device Evaluation (ODE) as the Deputy Director for Engineering and Science and Associate Director for Regulations and Guidance; a Regulatory Advisor and Policy Analyst; CDRH Product Jurisdiction Officer; and a Scientific Reviewer in the Division of Cardiovascular Devices. Ms. Krueger holds degrees in Chemistry and Journalism from Butler University, Indianapolis, Indiana.

April Marrone

Program Lead

Total Product Life Cycle Advisory Program (TAP)

April leads the FDA/CDRH Total Product Life Cycle (TPLC) Advisory Program (TAP). Prior to her current role, April has served on the Obesity and Hepatobiliary Devices Team as the acting Assistant Director, Team Lead, Lead Reviewer, and chemistry consultant. In addition to supervisory, leadership, and medical device review responsibilities, April has promoted improvement in product manufacturing and quality through developing device specific FDA guidance documents, creating review tools to ensure consistency and quality in device review, and publishing external manuscripts on topics relevant to the FDA and industry on topics in the obesity and hepatobiliary device space. April has served as a Commissioner Fellowship Program (CFP) preceptor, mentor to new reviewers and advisors, and has developed and instructed Reviewer Certification Program courses. Prior to joining CDRH, April was a Commissioner Fellow at FDA’s National Center for Toxicology Research (NCTR) and served on the CFP Advisory Board. Prior to joining the FDA, April completed post-doctoral training at the University of Pittsburgh, Children’s Hospital of Pittsburgh and the Max Planck Institute for Biophysical Chemistry. April completed her doctoral training at the University of Central Florida’s National Center for Forensic Science.

Keisha R. Thomas, MS, MHS, CQA, RAC

Associate Director for Compliance & Quality

U.S. Food and Drug Administration
CDRH/Office of Product Quality and Evaluation

Keisha Thomas is the Associate Director for Compliance and Quality in FDA’s Center for Devices and Radiological Health. She provides strategic oversight, coordination and guidance over medical device quality, compliance, and enforcement efforts. Ms. Thomas is a coauthor of the recently implemented amendment to 21 CFR 820, “Quality Management System Regulation (QMSR)”—incorporating the requirements of ISO 13485:2016; and spearheaded FDA’s implementation efforts for the proposed regulation. She has been at CDRH for 23 years and has an extensive regulatory, compliance, and enforcement background. Ms. Thomas has held multiple positions in CDRH, including Deputy Office Director for OPEQ/OHT1, Deputy Director for the Division of Premarket and Labeling Compliance, and Deputy Director for the Division of Enforcement A, and Quality System Team Lead in the former Office of Compliance, CDRH.

   
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