Conference | Mixed
Event Title
FDA Grand Rounds – Real-World Evidence Series: Center for Devices and Radiological Health RWE Program and Recent RWE Examples
October 22, 2026
- Date:
- October 22, 2026
- Time:
- 12:00 p.m. - 1:00 p.m. ET
- Location:
-
Event LocationFDA Headquarters
FDA White Oak Campus
10903 New Hampshire Ave, Building 31
The Great Room
Silver Spring, MD 20903
United States
About the Speakers
Sanjula Jain-Nagpal, Ph.D.
Associate Director of Policy and Research Strategy
Office of the Commissioner
U.S. Food & Drug Administration
Sanjula Jain-Nagpal, Ph.D. is the Associate Director of Policy & Research Strategy in the Office of the FDA Commissioner, where she applies her expertise in real-world data, health services research, and healthcare forecasting to inform regulatory policy. She brings a unique perspective to the FDA from building and leading research, product, and business strategy efforts that use large-scale healthcare data to translate complex information into actionable insights.
Prior to joining the FDA, Dr. Jain-Nagpal served as Chief Research Officer and Senior Vice President of Market Strategy at Trilliant Health, where she led the company’s thought leadership agenda and strategic advisory work for C-suite executives while overseeing the market research business. Throughout her career, she has held executive leadership, research, and strategy roles across the healthcare ecosystem and served on the faculty at the Johns Hopkins School of Medicine, where she taught courses in digital health.
Dr. Jain-Nagpal earned her undergraduate degree in Psychology and Biology from Rice University and holds a Ph.D. in health services research and health policy, with a concentration in economics, from Emory University.
Michelle Tarver, M.D., Ph.D.
Director
Center for Devices and Radiological Health
U.S. Food & Drug Administration
Dr. Michelle Tarver is a public health executive and board-certified ophthalmologist 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 the FDA, including Deputy Director of the Office of Strategic Partnerships and Technology Innovation and 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 experience in crafting regulations and guidances and conducting premarket and postmarket reviews. She most recently served as Deputy Center Director for Transformation, steering 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 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.
Daniel Caños, Ph.D., M.P.H.
Director
Office of Clinical Evidence and Analysis
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
U.S. Food & Drug Administration
Daniel Arthur Caños, Ph.D., M.P.H., is the Director of the Office of Clinical Evidence and Analysis (OCEA) in the FDA Center for Devices and Radiological Health (CDRH). Prior to joining CDRH in 2019, Daniel was the Director of the Evidence Development Division in the Centers for Medicare and Medicaid Services (CMS) Coverage and Analysis Group (CAG) leading National Coverage Determinations involving Coverage with Evidence Development and review of FDA approved Investigational Device Exemption studies for CMS coverage determination. Before joining CAG in 2016, Daniel was an Associate Director in the FDA CDRH Division of Epidemiology originally joining FDA in 2008. He received a B.A. in psychology from the University of Cincinnati, M.P.H. from the George Washington University, and Ph.D. in Epidemiology from the University of North Carolina at Chapel Hill.
Aneesh Deoras, M.S.
Division Director for Digital Health Technology Assessment
Digital Health Center of Excellence
Office of Strategic Partnerships and Technology Innovation
Center for Devices and Radiological Health
U.S. Food & Drug Administration
Aneesh Deoras is the Division Director for Digital Health Technology Assessment in CDRH’s Digital Health Center of Excellence. He has been with the FDA for 11 years, primarily in the Office of Cardiovascular Devices. Aneesh holds a bachelor’s in electrical engineering from Penn State and a master’s in bioengineering from Penn.
Lora Weidner, Ph.D.
Assistant Director
Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
U.S. Food & Drug Administration
Dr. Lora Weidner received a B.S. in neuroscience from the University of Pittsburgh in 2011 and her Ph.D. in neuroscience from Karolinska Institute in 2017. Her doctoral and postdoctoral research focused on the development of diagnostic radioligands for PET imaging of neurological and psychiatric disorders. Dr. Weidner joined the FDA in 2019, reviewing submissions for radiation therapy and nuclear medicine devices. Since 2022, she has served as the Assistant Director of the Radiation Therapy team in the Center for Devices and Radiological Health.
About the Presentation
This session will highlight the Real-World Evidence (RWE) Program at the FDA’s Center for Devices and Radiological Health (CDRH), with a focus on recent RWE examples in the digital health technology space. Through presentations and panel discussion with CDRH experts, participants will gain practical insight into CDRH's RWE Program and explore how these principles could support evidence generation.
This event will be offered in a hybrid format, with options to attend in person at the FDA White Oak Campus or virtually via webcast.
Note: this is the first of a three-part RWE series. Future sessions will discuss the RWE programs and recent RWE examples within the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research.
Learning Objectives
- Describe CDRH's RWE Program. Participants will be able to describe the milestones and evolution of CDRH’s Real-World Evidence Program.
- Analyze examples of RWE use in CDRH regulatory decisions. Participants will be able to identify examples of RWE use in medical device regulatory decisions — including recent examples in digital health — and explain the role real-world data/real-world evidence played in supporting those decisions.
To Attend
Participants may attend either virtually via Zoom or in person at FDA White Oak in Silver Spring, MD.
Virtual Attendance: Register to attend via Zoom
In-Person: Register to attend in person at FDA White Oak – Great Room
For technical assistance please contact: Rakesh.Raghuwanshi@fda.hhs.gov; Ayan.Ibrahim@fda.hhs.gov
Continuing Medical Education (CME) Credit
As CME credit is being offered through the Johns Hopkins University School of Medicine, those wishing to obtain CME credit must create a user profile on the Hopkins Cloud CME platform. If you have never had a CME certificate/credits awarded and need a user profile created, please log onto https://hopkinscme.cloud-cme.com and click the “Sign Up Now” button. DO NOT create a new account if you have already received credit for Johns Hopkins CME activities at any time. Click on Forgot Password if you already have an email on file with the JHU OCME office. Instructions on how to claim the CME credit will be provided during the Grand Rounds presentation, but participants must already have a Hopkins Cloud CME user profile before the presentation.
Accreditation Statement
The Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
Credit Designation Statement
The Johns Hopkins University School of Medicine designates this live activity for a maximum of 1 AMA PRA Category 1 Credit. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This regularly scheduled series has been approved for a 52-week cycle beginning October 23, 2025.
Other Credits
Reciprocity exists with the following boards that accept AMA PRA Category 1 Credits™ from organizations accredited by the ACCME:
- American Nurses Credentialing Center
- American Academy of Nurse Practitioners National Certification Program
- National Commission on Certification of Physicians Assistants
- Psychologists: JHUSOM is authorized by the Maryland State Board of Examiners of Psychologists as a provider of continuing education. The JHUSOM maintains responsibility for this program.
- Social Workers: The Maryland Board of Social Work Examiners certifies that this program meets the criteria for 1 credit hour of Category 1 of continuing education for social workers licensed in Maryland. The JHUSOM is an approved sponsor of the Maryland Board of Social Work Examiners for continuing education credits for licensed social workers in Maryland.
These professionals should submit their transcript to their respective boards to convert their credits to CEUs.
Policy on Presenter and Provider Disclosure
It is the policy of the Johns Hopkins University School of Medicine that the presenter globally disclose conflicts of interest and any discussion of unlabeled/unapproved uses of drugs or devices during their presentation(s). The Johns Hopkins University School of Medicine OCME has established policies in place to identify and mitigate relevant conflicts of interest prior to this educational activity. Detailed disclosure will be made prior to presentation of the education.