Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                FDA Organization

FDA Organization

                        


                        Office of the Commissioner
          Center for Biologics Evaluation and Research (CBER)
          Center for Devices and Radiological Health
          Center for Drug Evaluation and Research | CDER
          Center for Food Safety and Applied Nutrition (CFSAN)
          Center for Tobacco Products
          Center for Veterinary Medicine
          Office of Regulatory Affairs
          Oncology Center of Excellence
          FDA’s Proposal for a Unified Human Foods Program and New Model for the Office of Regulatory Affairs
          FDA Organization Charts Home
          About FDA
          FDA Organization
          Jeffrey ShurenFDA Organization Dr.
        
                 Jeffrey 
         
                            E. 
        
                 Shuren 
         
                                    
    MD,    JD
        
                
                    Leadership Role
          Director - CDRH Offices:  Office of the Center Director 
                
    Share
    Post
    Linkedin

    Email
    PrintJeff Shuren M.D., J.D.


            Dr. Jeffrey E. Shuren 
    MD,    JDJeff Shuren is the Director of the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration. The center is responsible for assuring the safety, effectiveness, and quality of medical devices; assuring the safety of radiation-emitting products (such as cell phones and microwave ovens); and fostering device innovation.

"Our center experts and programs help get safe and effective technologies to patients and health care professionals on a daily basis and continue to assure devices are safe and effective once on the market," says Dr. Shuren. "Rapid technological advances enable us to approve innovations that make a difference in people’s lives. I could not be more proud of my fellow colleagues at CDRH, the family we have built, and what we have accomplished together on behalf of the American public."

Dr. Shuren received his B.S. and M.D. degrees from Northwestern University under its Honors Program in Medical Education. He completed his medical internship at Beth Israel Hospital in Boston, his neurology residency at Tufts New England Medical Center, and a fellowship in behavioral neurology and neuropsychology at the University of Florida. He subsequently joined the faculty of the University of Cincinnati. He received his J.D. from the University of Michigan. He is board certified in neurology and a member of the State of Maryland bar.

Dr. Shuren held various policy and planning positions within the FDA’s Office of the Commissioner from 1998 to 2009, including Medical Officer in the Office of Policy; Assistant Commissioner for Policy; Associate Commissioner for Policy and Planning; Special Counsel to the Principal Deputy Commissioner; and Acting Deputy Commissioner for Policy, Planning, and Budget.

From 1999 to 2000, Dr. Shuren served as a detailee on Senator Edward Kennedy's staff on the Senate Health, Education, Labor, and Pensions Committee. From 1998 to 2003, while at the FDA, he also served as a staff volunteer in the National Institutes of Health’s Cognitive Neuroscience Section, where he supervised and designed clinical studies on human reasoning.

As Director of the Division of Items and Devices, Coverage and Analysis Group at the Centers for Medicare and Medicaid Services (CMS) from 2001 to 2003, Dr. Shuren oversaw the development of Medicare national coverage determinations for drugs, biologics, and non-implantable devices.

Dr. Shuren became the Acting Director of CDRH beginning in September 2009 and was appointed the permanent Director in January 2010. During his tenure, Dr. Shuren has envisioned and implemented initiatives to modernize the regulation of medical devices through a holistic, patient-centric, customer service-focused, total product life cycle approach to oversight and the organizational structure of CDRH. These efforts include conceiving and co-founding the International Medical Device Regulators Forum  to foster global harmonization and the Medical Device Innovation Consortium  to advance regulatory science in support of developing innovative technologies and improving device safety and cybersecurity; envisioning and supporting the establishment of the National Evaluation System for health Technology  to generate real-world evidence to support device authorizations and identify and characterize safety signals; launching the Case for Quality Initiative to improve device quality and safety and facilitate the adoption of advanced manufacturing technologies; the Breakthrough Devices Program and Safety and Performance Based Pathway to address the unmet medical needs of people and foster the development of safer, more effective technologies; the Collaborative Communities Initiative to drive the development of community-generated solutions within the medical device ecosystem; the Network of Experts to expedite and expand access to external expertise to inform center decision making, and the Parallel Review Program with CMS to streamline the pathway from FDA authorization to CMS national coverage determination; and spearheading CDRH’s efforts on patient engagement and the science of patient input, including creation of the Patient Engagement Advisory Committee , advancing the development of digital health technologies and the creation of the Digital Health Center of Excellence, and piloting the Total Product Life Cycle Advisory Program  to expedite patient and health care professional access to and spur greater investment in the development of breakthrough devices.

Resources For You

FDA Leadership Profiles
	About the Center for Devices and Radiological Health
	FDA Basics

                                                                                  Content current as of:
      01/23/2024FDA Organization

          
                        


                        Office of the Commissioner
          Center for Biologics Evaluation and Research (CBER)
          Center for Devices and Radiological Health
          Center for Drug Evaluation and Research | CDER
          Center for Food Safety and Applied Nutrition (CFSAN)
          Center for Tobacco Products
          Center for Veterinary Medicine
          Office of Regulatory Affairs
          Oncology Center of Excellence
          FDA’s Proposal for a Unified Human Foods Program and New Model for the Office of Regulatory Affairs
          FDA Organization Charts
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop