U.S. FOOD & DRUG Administration

Dr. Michelle Tarver is a visionary public health executive, board-certified in ophthalmology with a doctorate in epidemiology, who serves as the Acting Center Director of the Center for Devices and Radiological Health (CDRH).  She attended Spelman College in Atlanta, GA where she received a B.S. in biochemistry. She completed the M.D./Ph.D. program at The Johns Hopkins University Bloomberg School of Public Health in 2002, earning her Ph.D. in clinical epidemiology and her M.D. at the Johns Hopkins School of Medicine in 2003. 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 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 health care ecosystem, and stimulate creative evidence generation pathways.  As a dedicated clinician, she continues to care for people living with inflammatory eye conditions.

As an entrepreneurial leader, Dorn leads strategic initiatives to advance OSEL’s mission to accelerate patient access to innovative, safe, and effective medical devices through best-in-the-world regulatory science. This includes fostering and establishing collaborations with federal agencies like the National Science Foundation, National Institutes of Health, Veterans Health Administration, more than 70 universities, philanthropic organizations and a top medical devices ecosystem actors committed to advancing regulatory science for development of safe and effective medical devices. Prior to the FDA, Dorn managed a portfolio of federally-funded science & technology innovation and commercialization programs aimed to boost the impact of research and technology-based entrepreneurship in the U.S. He has led life sciences, biotech and medical technology innovation, commercialization and business development programs in the San Francisco Bay Area for major corporations and startup companies. As a Hispanic scientist and innovation strategist, he is a speaker, mentor and national advocate for diversity, inclusion, and broadening participation in science, technology, engineering and mathematics (STEM) and the innovation economy.

Gilandra Russell is a biomedical research scientist and toxicologist. She is currently serving as a Senior Staff Fellow at the FDA's Center for Devices and Radiological Health (CDRH), in the Office of Product Evaluation and Quality (OPEQ) and the Division of Infection Control and Plastic Surgery Devices. Gilandra plays a pivotal role in evaluating medical device products throughout their life-cycle. Her responsibilities include shaping regulatory guidelines and providing high-level toxicological consulting and risk assessments.

Gilandra recieved a B.S. in Chemistry from the University of Louisville and a Ph.D. in Pharmacology and Toxicology from the University of Louisville School of Medicine. She has been honored with various fellowships and awards throughout her career, including a Fellowship from the National Institute of Environmental Health Sciences (NIEHS).

Before joining the FDA, Gilandra’s academic career included interdisciplinary and integrative research in the environmental health sciences, which involved finding novel compounds in food and plants to treat, as well as prevent, environmentally induced malignancies. She has also developed pre-clinical models of toxicity to evaluate the development and progression of environmentally induced disease. In addition to her academic work, she has also spent over a decade in industry as a regulatory and safety scientist, as well as a scientific consultant. Involved in overseeing significant projects related to safety and risk management, and advising on regulatory strategies related to food, pharmaceuticals, and cosmetics.

Gilandra has been published in several journals, including the Journal of Pharmacology and Experimental Therapeutics, Mutation Research, and Carcinogenesis. She is currently a member of the Society of Toxicology and the American Chemical Society.

Gabrielle Clark-Patterson is a General Engineer at the FDA within the Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health. She leads the review of premarket submissions for robotically-assisted surgical devices (RASD). Gabrielle is also involved with establishing consistent review practices within OPEQ for robotic medical devices and developing international standards for evaluating robotic medical devices used during surgery.

Gabrielle was first introduced to RASD while attending the University of Central Florida, where she received a Bachelor of Science in Mechanical Engineering. For her senior design project, she designed and built a mechanical structure supporting a RASD permitting operation in a surgical environment. Prior to joining FDA, Gabrielle received a Doctor of Philosophy in Biomedical Engineering from Tulane University. Her doctoral research focused on developing mechanical testing protocols to characterize the contractile and viscoelastic mechanical properties of the female reproductive organs.

Terry O. Woods is the director of the Division of Standards & Conformity Assessment in the FDA’s Center for Devices & Radiological Health. She leads the program’s efforts to accelerate medical device development through the strategic use of consensus standards, working to promote conformity assessment and the development of regulatory ready standards with a goal of providing patients access to innovative, safe and effective medical devices. Prior to this role, Dr. Woods served as a White House Leadership Development Program Fellow directing the Results-Oriented Accountability for Grants Cross Agency Priority Goal in the Office of Management and Budget.

Dr. Woods is a Fellow with ASTM International and served on the Board of Directors.  She participates in standards development with numerous national and international standards organizations and serves in several leadership roles and policy committees.  She is also a Fellow of the American Institute for Medical and Biological Engineering and was named in the Top Ten Federal Engineers by the National Society of Professional Engineers in 2009.  Dr. Woods earned her Ph.D. in Engineering Science and Mechanics from the Georgia Institute of Technology.

Jianchao Zeng, Ph.D., is the Director of the Standards Management Program and Assistant Director of the Division of Standards and Conformity (DSCA) at FDA’s Center for Devices and Radiological Health (CDRH).  Dr. Zeng has been with the FDA/CDRH for more than 16 years. He has served as a lead premarket reviewer for medical devices before moving to DSCA, where for the past 14 years he has led standards development and conformity assessment activities, both nationally and internationally. Dr. Zeng has actively participated in various Standards Developing Organizations’ technical committees and has represented FDA at the US National Committee (USNC) for IEC and IECEE.

Dr. Zeng is a Regulatory Affairs Certificate holder, an American Society for Quality’s Certified Quality Auditor, and is certified at the AStd level with the Society for Standards Professionals. He is a recipient of the 2018 ANSI Meritorious Service Award.

Prior to joining the Agency, Dr. Zeng was a faculty member at Georgetown University Medical Center and Howard University’s Department of Electrical and Computer Engineering. His areas of research included medical imaging, image analysis and clinical applications.

Scott Colburn is the Director of the Office of Readiness and Response (ORR) at the Food and Drug Administration’s Center for Devices and Radiological Health. In this role, Scott is responsible for the overall leadership and strategic direction on medical device cybersecurity, standards and conformity assessment while providing oversight and coordination related to public health emergency preparedness and response. He is a member to many standards developing organizations (SDO) policy and strategy committees and currently is the Chair of ISO TC210 - Quality management and corresponding general aspects for products with a health purpose including medical devices.

After a span of 27 years serving in the US Army and US Public Health Service Commissioned Corps as a nurse, regulator and public health advocate, Scott continued his career as a civil servant through his role at FDA to drive his passion for standardization and global harmonizing engaging with organizations like the International Medical Device Regulators Forum [IMDRF], and his numerous affiliations across dozens of SDOs.

Heather Agler is a Senior Science Health Advisor in the Division of All Hazard Preparedness Response (DAPR) in FDA’s Center for Devices Radiological Health and has been working for the FDA for 19 years. As the lead of the Medical Countermeasure Innovation Program, Dr. Agler works as a liaison to government agencies on the medical device development needs. She works with agencies, academia, industry, and the CDRH review divisions to reduce the regulatory hurdles that often accompany bringing new, high-risk / high-benefit, medical countermeasure technology to market. At the beginning of the COVID-19 pandemic response, Dr. Agler worked on ways to make ventilators accessible and on the emergency use authorization process. Before joining DAPR, she worked on interoperability of medical devices, wireless technology in medical devices, digital health, and device classification. Dr. Agler was also an engineering reviewer and lead reviewer in the Office of Device Evaluation/CDRH/FDA. She reviewed interventional cardiology devices such as drug-eluting stents and cardiac occluders in the Division of Cardiovascular Devices. Prior to her work at the FDA, Dr. Agler was Christine Mirzayan Fellow at the National Academies. She also received a National Science Foundation Fellowship for graduate school. Dr. Agler has a B.S. in chemical engineering from the University of South Carolina and a Ph.D. in biomedical engineering from the Johns Hopkins School of Medicine.

Julia Madaras is the Division Director for All-Hazards Preparedness & Response (DAPR) in the Center for Devices and Radiological Health (CDRH) at the Food & Drug Administration (FDA). Known by most as Julie, she joined FDA in May 2001 as a nurse consultant after 15 years of critical care nursing. She has a Master of Science in trauma/critical care nursing from the University of Maryland. Within CDRH, Julie has been leading DAPR since September 2016 and guided the team through the historical and complex COVID-19 public health emergency. As Director, Julie is responsible for leading, planning and implementing CDRH’s emergency preparedness, incident response, and medical counter measure activities. She has made significant strides moving from a responsive posture to a culture of preparedness in CDRH and has recently operationalized a CDRH response structure for information and data management during emergencies that aligns with CDRH’s strategic priority of enhancing agility and resilience.

Frank Block III is a senior health scientist with the Office of Strategic Partnerships and Technology Innovation at the US Food and Drug Administration in Silver Spring, Maryland. He also holds an appointment as an Adjoint Assistant Professor of Biomedical Engineering at Vanderbilt University. He received his BS degrees in Electrical and Biomedical Engineering and his MS and PhD in Electrical Engineering from the University of Virginia in Charlottesville, Virginia, and completed his postdoctoral research in Biomedical Engineering at Vanderbilt University in Nashville, Tennessee.

CDR Scott Steffen is a United States Public Health Service Officer serving as a Senior Program Management Officer for the United States Food and Drug Administration (FDA) in the Office of Readiness & Response. Over 4 years in this capacity he assisted in responses for COVID-19, highly pathogenic avian influenza, various healthcare associated infections, and numerous hurricanes. Currently, he has been also serving as the Ethylene Oxide Incident co-lead for four years. He has over 15 years of emergency response and regulatory experience spanning both the Center for Drug Evaluation and Research (CDER) or Center for Devices and Radiological Health (CDRH). Earlier in his FDA Career, he served as a microbiology/sterility reviewer and/or Team Lead for both CDER and CDRH completing over 800 sterility assurance reviews of Premarket Applications. He has Bachelor of Science degree from the Pennsylvania State University in Biochemistry and a doctoral degree in Biochemistry and Molecular Cell Biology from the Johns Hopkins Bloomberg School for Public Health. He also completed a post-doctoral fellowship studying enzymatic mechanisms of various Ebola proteins at Fort Detrick. Afterwards, he held various research positions investigating potential cancer targets and vaccine candidates at three different biotech companies before joining FDA. CDR Steffen holds five certifications as a Certified Quality Improvement Associate, Certified Quality Inspector, Certified Quality Technician, Certified Quality Process Analysis, and Certified Six Sigma Yellow Belt from the American Society of Quality.

CDR Tamara Rosbury has served as a Health Scientist since January 2024 with FDA’s Center for Devices and Radiological Health (CDRH) towards reducing the medical device industry’s reliance on Ethylene Oxide sterilization. She is an active-duty officer in the United States Public Health Service and began her FDA career in 2010 as an Investigator evaluating domestic and international medical device manufacturer’s quality systems for compliance with Current Good Manufacturing Practices (CGMPs). In 2016, she began serving as a Compliance Officer in the Center for Drug Evaluation and Research evaluating pharmaceutical manufacturer’s quality systems for compliance with CGMPs. CDR Rosbury obtained her Ph.D. and S.M. from MIT in the Department of Electrical Engineering and Computer Science in 2006 and 2000, respectively and a B.S. in Physics from Tennessee State University in 1998.

Tracy Ulderich is currently a Senior Science Health Advisor in the Division of All Hazards Preparedness and Response (DAPR) at FDA/CDRH. In her role she provides critical support for advancing national preparedness and response efforts for CBRNE, emerging infectious diseases, natural disaster threats and supports the development of medical countermeasure devices with a particular focus on PPE. Prior to her current position, Mrs. Ulderich was the Branch Chief of the Regulatory Business and Support Office within the U.S. Army Medical Research & Development Command (USAMRDC) where she led a team of administrative and regulatory operations professionals in the areas of medical writing, document control, submissions, and information technology to support medical product development efforts for the Department of Defense. Tracy earned her Master of Science in Biomedical Science with a concentration in Regulatory Compliance from Hood College.

Charlie Haggart, Ph.D., is CDRH’s Chief Data Steward. In his current role, Dr. Haggart has led the development of the Center’s enterprise data model and data dictionary and continues to  lead the architectural design and development of the CDRH Enterprise Data hub (CEDh), leveraging a diverse community of business (analysts, data owners, SMEs) and technical (data modelers, data managers, data engineers and data scientists) stakeholders to deliver a flexible and powerful data and analytics platform. Over the past several years, Dr. Haggart has established the Data Stewardship role in the Center, taking a comprehensive approach to defining and implementing enterprise data, improving data quality, and building and operating an effective data governance program. Prior to his current role, Dr. Haggart has a range of experience at CDRH across quality management and organization excellence, medical device innovation, and pre-market review of cardiovascular devices.

Ali Russo is the Chief Data Officer in the Center for Center for Devices and Radiological Health. Ali joined the FDA in 2023 to lead the Data Modernization efforts within the Center. She has over 25 years of experience in standing up successful data and analytic programs. Prior to the FDA, Ali served as the Chief Information Officer at FAIR Health, a non-profit organization with the mission to increase healthcare price transparency and the largest private healthcare claims repository in the United States. Ali has also served as the Director of Analytic Services for McKesson, Corp. She has a Master of Public Health from the George Washington University Milken School of Public Health.

Randi Scott, MS is the Data Modernization Analytics and Reporting Lead in CDRH’s Office of Strategic Partnership and Technology Innovation. In line with CDRH’s Data Modernization goals, Randi oversees the Center’s implementation of innovative products and strategies to meet staff reporting needs. She also spearheads increased usage of Artificial Intelligence and Machine Learning in CDRH to assist with workflow efficiency, text analysis of FDA documentation, and more. Prior to the FDA, Randi worked in healthcare analytics at a non-profit organization and the NYC Department of Health & Mental Hygiene. She holds a Master of Science in Quantitative Methods in the Social Sciences from Columbia University.

Mark helps lead the Office of Supply Chain Resilience horizon scanning efforts.  He has over 30 years of experience supporting and leading federal government supply chain operations.  He is passionate about developing and utilizing information technology and supply chain management methodologies to enable innovative solutions.

Nate is a Supply Chain Specialist supporting OSCR.  Nate has over 30 years of supply chain and process transformation experience across both private and public organizations.

Ryan is a global health supply chain specialist supporting OSCR. His previous work includes supporting supply chain operations for USAID related to delivering HIV and Malaria medicine to hard-to-reach communities.

Ed is a Supply Chain Risk Specialist supporting OSCR.  Ed has over 15 years of medical supply chain experience and management at various organizational levels.

Thomas is a Senior Staff Fellow in OSCR. With a background as a physician, Thomas helps the team put many of the medical devices in context, while also performing supply chain analysis for many other devices.

Monroe J. Molesky, MPH is a Cybersecurity Specialist in the Office of Strategic Partnerships and Technology Innovation (OST) at the U.S. Food and Drug Administration (FDA). As part of OST’s Division of Medical Device Cybersecurity, he examines issues and develops policy related to the safety, effectiveness, and cybersecurity of connected medical devices including coordinating incident responses, drafting policy documents, and engaging with other federal agencies and sector stakeholders. Previously, Monroe served in roles at the Cybersecurity and Infrastructure Security Agency, U.S. Department of Health and Human Services, U.S. Forest Service, and worked in consulting. Monroe received his BS in Integrative Physiology and History, MPH in Health Policy, and is currently completing both an MBA and a Doctorate in Health Administration. Monroe was also a National CyberCorps Scholarship-for-Service recipient.

Gilandra Russell is a biomedical research scientist and toxicologist. She is currently serving as a Senior Staff Fellow at the FDA's Center for Devices and Radiological Health (CDRH), in the Office of Product Evaluation and Quality (OPEQ) and the Division of Infection Control and Plastic Surgery Devices. Gilandra plays a pivotal role in evaluating medical device products throughout their life-cycle. Her responsibilities include shaping regulatory guidelines and providing high-level toxicological consulting and risk assessments.

Gilandra recieved a B.S. in Chemistry from the University of Louisville and a Ph.D. in Pharmacology and Toxicology from the University of Louisville School of Medicine. She has been honored with various fellowships and awards throughout her career, including a Fellowship from the National Institute of Environmental Health Sciences (NIEHS).

Before joining the FDA, Gilandra’s academic career included interdisciplinary and integrative research in the environmental health sciences, which involved finding novel compounds in food and plants to treat, as well as prevent, environmentally induced malignancies. She has also developed pre-clinical models of toxicity to evaluate the development and progression of environmentally induced disease. In addition to her academic work, she has also spent over a decade in industry as a regulatory and safety scientist, as well as a scientific consultant. Involved in overseeing significant projects related to safety and risk management, and advising on regulatory strategies related to food, pharmaceuticals, and cosmetics.

Gilandra has been published in several journals, including the Journal of Pharmacology and Experimental Therapeutics, Mutation Research, and Carcinogenesis. She is currently a member of the Society of Toxicology and the American Chemical Society.

Gabrielle Clark-Patterson is a General Engineer at the FDA within the Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health. She leads the review of premarket submissions for robotically-assisted surgical devices (RASD). Gabrielle is also involved with establishing consistent review practices within OPEQ for robotic medical devices and developing international standards for evaluating robotic medical devices used during surgery.

Gabrielle was first introduced to RASD while attending the University of Central Florida, where she received a Bachelor of Science in Mechanical Engineering. For her senior design project, she designed and built a mechanical structure supporting a RASD permitting operation in a surgical environment. Prior to joining FDA, Gabrielle received a Doctor of Philosophy in Biomedical Engineering from Tulane University. Her doctoral research focused on developing mechanical testing protocols to characterize the contractile and viscoelastic mechanical properties of the female reproductive organs.

Terry O. Woods is the director of the Division of Standards & Conformity Assessment in the FDA’s Center for Devices & Radiological Health. She leads the program’s efforts to accelerate medical device development through the strategic use of consensus standards, working to promote conformity assessment and the development of regulatory ready standards with a goal of providing patients access to innovative, safe and effective medical devices. Prior to this role, Dr. Woods served as a White House Leadership Development Program Fellow directing the Results-Oriented Accountability for Grants Cross Agency Priority Goal in the Office of Management and Budget.

Dr. Woods is a Fellow with ASTM International and served on the Board of Directors.  She participates in standards development with numerous national and international standards organizations and serves in several leadership roles and policy committees.  She is also a Fellow of the American Institute for Medical and Biological Engineering and was named in the Top Ten Federal Engineers by the National Society of Professional Engineers in 2009.  Dr. Woods earned her Ph.D. in Engineering Science and Mechanics from the Georgia Institute of Technology.

Jianchao Zeng, Ph.D., is the Director of the Standards Management Program and Assistant Director of the Division of Standards and Conformity (DSCA) at FDA’s Center for Devices and Radiological Health (CDRH).  Dr. Zeng has been with the FDA/CDRH for more than 16 years. He has served as a lead premarket reviewer for medical devices before moving to DSCA, where for the past 14 years he has led standards development and conformity assessment activities, both nationally and internationally. Dr. Zeng has actively participated in various Standards Developing Organizations’ technical committees and has represented FDA at the US National Committee (USNC) for IEC and IECEE.

Dr. Zeng is a Regulatory Affairs Certificate holder, an American Society for Quality’s Certified Quality Auditor, and is certified at the AStd level with the Society for Standards Professionals. He is a recipient of the 2018 ANSI Meritorious Service Award.

Prior to joining the Agency, Dr. Zeng was a faculty member at Georgetown University Medical Center and Howard University’s Department of Electrical and Computer Engineering. His areas of research included medical imaging, image analysis and clinical applications.

Scott Colburn is the Director of the Office of Readiness and Response (ORR) at the Food and Drug Administration’s Center for Devices and Radiological Health. In this role, Scott is responsible for the overall leadership and strategic direction on medical device cybersecurity, standards and conformity assessment while providing oversight and coordination related to public health emergency preparedness and response. He is a member to many standards developing organizations (SDO) policy and strategy committees and currently is the Chair of ISO TC210 - Quality management and corresponding general aspects for products with a health purpose including medical devices.

After a span of 27 years serving in the US Army and US Public Health Service Commissioned Corps as a nurse, regulator and public health advocate, Scott continued his career as a civil servant through his role at FDA to drive his passion for standardization and global harmonizing engaging with organizations like the International Medical Device Regulators Forum [IMDRF], and his numerous affiliations across dozens of SDOs.

Niloufar Jafari is a Biomedical Engineer Staff Fellow at the U.S. Food and Drug Administration, supporting the Pediatrics and Special Populations program. With a Master of Engineering in Biomedical Engineering and a Concept, Creation, Commercialization (C3) certificate in engineering entrepreneurship from Texas A&M University, and experience working with medical device start-ups, Niloufar brings a comprehensive approach to early-stage product development. Her expertise includes needs finding, customer discovery, market analysis, and prototyping, enabling her to drive innovative solutions from concept to commercialization. As a former product development lead and project manager, Niloufar leveraged her skills to guide projects through complex stages ensuring alignment with regulatory standards and market needs.

Erin Zenilman, M.D., is a medical officer on the Pediatrics and Special Populations team in the Center for Devices and Radiological Health (CDRH). Dr. Zenilman specializes in pediatric anesthesiology and worked in private practice prior to joining the FDA as a clinical reviewer in the Center for Drug Evaluation and Research (CDER) in 2019. She earned her undergraduate degree from the University of Pennsylvania and her medical degree from Rutgers-Robert Wood Johnson Medical School. She lives in Rockville, Maryland and enjoys listening to folk music, walking in nature, doing yoga, and spending time with her family.

Dr. Peiris serves as the Chief Medical Officer for Pediatrics and Special Populations at the Center for Devices and Radiological Health.

As Chief Medical Officer for Pediatrics and Special Populations at the U.S. FDA CDRH, Vasum provides executive and clinical leadership on Center policies and initiatives associated with medical devices intended for use in pediatric and special populations. He is the Center’s senior clinical expert on pediatrics and pediatric medical device issues. He leads systems development to facilitate internal and external innovation and synergy that enhances the ability of the Center and the Agency to optimally meet the medical device needs of historically underserved populations.

Prior to joining the FDA, Vasum was the Joon Park MD Endowed Chair in Medical Excellence and Chief of Pediatric and Adult Congenital Cardiology at Texas Tech University Health Sciences Center (TTUHSC). With appointments in both the Departments of Pediatrics and (adjunct) Internal Medicine, he provided full spectrum cardiovascular critical care and outpatient services. He helped develop the TTUHSC Clinical Research Institute, promoting patient-oriented translational and outcomes research, and was inaugural faculty of the Department of Public Health, assisting in development of the curricula offering unique training in rural health.

Vasum is triple-board certified in Pediatrics, Pediatric Cardiology and Adult Congenital Cardiovascular Disease. He completed his undergraduate and graduate degrees at Yale University and the Yale School of Medicine Department of Epidemiology and Public Health, his MD at the University of Vermont College of Medicine, Residency at Yale-New Haven Hospital/Yale School of Medicine and Fellowship and Senior Fellowship at Children’s Hospital Boston/Harvard Medical School.

Mark helps lead the Office of Supply Chain Resilience horizon scanning efforts.  He has over 30 years of experience supporting and leading federal government supply chain operations.  He is passionate about developing and utilizing information technology and supply chain management methodologies to enable innovative solutions.

Nate is a Supply Chain Specialist supporting OSCR.  Nate has over 30 years of supply chain and process transformation experience across both private and public organizations.

Ryan is a global health supply chain specialist supporting OSCR. His previous work includes supporting supply chain operations for USAID related to delivering HIV and Malaria medicine to hard-to-reach communities.

Ed is a Supply Chain Risk Specialist supporting OSCR.  Ed has over 15 years of medical supply chain experience and management at various organizational levels.

Thomas is a Senior Staff Fellow in OSCR. With a background as a physician, Thomas helps the team put many of the medical devices in context, while also performing supply chain analysis for many other devices.

Monroe J. Molesky, MPH is a Cybersecurity Specialist in the Office of Strategic Partnerships and Technology Innovation (OST) at the U.S. Food and Drug Administration (FDA). As part of OST’s Division of Medical Device Cybersecurity, he examines issues and develops policy related to the safety, effectiveness, and cybersecurity of connected medical devices including coordinating incident responses, drafting policy documents, and engaging with other federal agencies and sector stakeholders. Previously, Monroe served in roles at the Cybersecurity and Infrastructure Security Agency, U.S. Department of Health and Human Services, U.S. Forest Service, and worked in consulting. Monroe received his BS in Integrative Physiology and History, MPH in Health Policy, and is currently completing both an MBA and a Doctorate in Health Administration. Monroe was also a National CyberCorps Scholarship-for-Service recipient.