BACKGROUND
FOCUS AREAS
AWARDS & HONORS
Former Director of the FDA’s Center for Devices and Radiological Health (CDRH); career includes service as a physician, senior FDA official, and member of the U.S. Public Health Service.
USFDA Regulatory Policy
Medical Devices and Combination Products
Medical Device Clinical Trials Design and Implementation
Strategic and Tactical Support
PHS Achievement Medal
Public Health Service Citation Medal
Public Health Service Commendation Medal
Public Health Service Crisis Response Award
Outstanding performance as Deputy Director, Clinical and Review Policy, ODE
Exemplary performance as the Director in the Office of Device Evaluation
Dr. Daniel Schultz joined Eliquent following a distinguished 50-year career devoted to supporting and advancing Americans’ public health as a physician, teacher, Food and Drug Administration (FDA) official, member of the US Public Health Service (USPHS) and regulatory expert. He has been recognized many times for his contributions and dedication to public health.
Dan continues his commitment to public health at Eliquent, where he provides strategic consulting services and works with Greenleaf clients to bring safe and innovative devices to patients.
As Director of the Center for Devices and Radiological Health (CDRH) at FDA from 2004–2009, Dan was responsible for seven FDA offices and more than 1,000 agency employees. He led the development, implementation, and evaluation of regulatory policies concerning medical devices and radiation-emitting products.
Dan began his 15-year FDA career in 1994 as a Medical Officer in the General Surgery Devices branch of the CDRH’s Office of Device Evaluation. In 1995, he advanced to Chief Medical Officer in the Office of Device Evaluation in the division of Reproductive, Abdominal, ENT, and Radiological Devices. He served as Division Director from 1998–2001. Dan became Deputy Director for Clinical and Review Policy in the Office of Device Evaluation in 2001 and Director of the Office of Device Evaluation the following year.
During his time at FDA, Dan took advantage of his medical knowledge and experience as Assistant Professor of Surgery at the Uniformed Services University of the Health Sciences and as a member of the Surgical Staff at the National Naval Medical Center in Bethesda, MD.
Before joining FDA, Dan served as a member of USPHS. During postings at Indian Health Service hospitals in Arizona and New Mexico, he provided medical care for people living in the Navajo Nation and Indian Pueblos. Dan received multiple awards for his service, including the Public Health Service Outstanding Medal.
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EDUCATION:
A New York City native, Dan is a graduate of the City College of New York.
He received his M.D. from the University of Pittsburgh and is board certified in Surgery and Family Practice.HONORS:
Medical School Class President, 1972 – 1974
Induction into the American College of Surgeons, October 13, 1994AWARDS:
1994 Service Award, Santa Fe Service Unit, Indian Health BoardPHS Achievement Medal
1995 PHS Citation Medal
1996 PHS Commendation Medal
PHS Crisis Response Award1997 FDA Group Recognition Award
1998 PHS Outstanding Unit Citation CDRH Achievement Award
1999 National Partnership for Reinventing Government: 515(b) Process Reengineering Team CDRH Hammer AWARD PHSOutstanding Service Medal
PHS Outstanding Unit Citation as a member of the FDAMA Device Implementation TeamPHS Unit Commendation as a member of the Breast Disease Diagnosis Coordinating Team
PHS Unit Commendation as a member of the CDRH Reinvention Teams
2002 Outstanding performance as Deputy Director, Clinical and Review Policy, ODE
2003 Exemplary performance as the Director and outstanding leadership in the Office of Device Evaluation
FDA Commissioner’s Special Citation as a member of the User Fee Legislative Team
CDRH Special Recognition Award as a member of the Endometrial Ablation Devices Working Group
CDER’s Team Excellence Award as a member of the Cancer Drug Development Patient Consultant Team
Commissioner’s Special Recognition Award as a member of the Cancer Drug Development Patient Consultant Program
Administration’s Leveraging/Collaboration Award as a member of the Tissue Safety Enforcement Group
2005 Certification of appreciation as a member of the Unified Financial Management team
2006 Commissioner’s Special Recognition Award for clearance of a new laboratory assay to detect Avian Influenza A/H5 (Asian Lineage)
2007 Commissioner’s Special Citation as a member of the FDA Pandemic Influenza Preparedness Task Force
CDRH Special Recognition Award as a member of the Medical Device Epidemiology Group
FDA Outstanding Service Award as a member of the ASR and IVDMIA Guidances Team
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PROFESSIONAL EXPERIENCE:
U.S. Food & Drug Administration (FDA)
Director, Center for Devices and Radiological Health (CDRH)
Director, Office of Device Evaluation (ODE), CDRH
Deputy Office Director for Clinical and Review Policy, ODE, CDRH
Division Director, Division of Reproductive, Abdominal, and Radiological Devices, ODE, CDRH
Division of Reproductive, Abdominal, ENT, and Reproductive Devices, CDRH
Division of General and Restorative Devices General Surgery Devices BranchCommissioned Corps of the U.S. Public Health Service
Chief of Surgery, Indian Hospital
Clinical Director, Indian Health Service Hospital
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