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Medical Devices

Public Workshop – Complex Issues in Developing Medical Devices for Pediatric Patients Affected by Rare Diseases, January 8, 2014

The Food and Drug Administration (FDA) is announcing a public Workshop entitled “Complex Issues in Developing Medical Devices for Pediatric Patients Affected by Rare Diseases.”

The purpose of the workshop is to discuss issues related to the following broad topics associated with medical devices for the diagnosis and treatment of pediatric patients affected by rare diseases: Current approaches toward use of medical devices for pediatric clinical practice; Humanitarian Device Exemption (HDE) marketing pathway, including the Humanitarian Use Device (HUD) designation process; Pediatric Specialty-Specific Practice Areas; Clinical Trials; Registries; Pediatric Needs Assessment; and Possible Approaches to Advancing Pediatric Medical Device Development. FDA is seeking input from these topics from academicians, clinical practitioners, patients and advocacy groups, industry, and governmental agencies.

FDA is also holding a separate public workshop entitled “Complex Issues in Developing Drug and Biological Products for Rare Diseases” on January 6-7, 2014 (Separate registration is required). The purpose of this workshop is to discuss complex issues in clinical trials for developing drug and biological products (“drugs”) for rare diseases. (Contact: Tomeka Arnett, 301-796-2500; email:; webpage:

Date, Time and Location:

This meeting was held January 8, 2014, beginning at 8:00 a.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

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Webcast Archive

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Agenda (Tentative) as of December 5, 2013

8:15 AM-8:25 AMWelcome and IntroductionJacqueline Francis and Linda Ulrich, (Moderators)

Michelle McMurry-Heath, MD, PhD
Associate Director for Science, Office of the Center Director, CDRH

Gayatri Rao, MD, JD
Director, Office of Orphan Products Development (OOPD)
8:25 AM-8:55 AMSession 1: What's Happening ClinicallyLinda Ulrich, MD (Moderator)
What’s Happening Clinically (10 min)James Geiger, MD
Director, University of Michigan Pediatric Device Consortium
Participant In-Put (20 min) 
8:55 AM-9:45 AMWhat We're (FDA) DoingJacqueline Francis, MD,MPH (Moderator)
FDA Programs Overview (15 min)Jacqueline Francis, MD, MPH
Medical Officer, CDRH
Pediatric Device Consortia Grants (10 min)Linda Ulrich, MD
Director, Pediatric Device Consortia Grant Program, OOPD
Medical Device Innovation Program (7 min)Michelle McMurry-Heath, MD, PhD
Associate Director for Science,
Office of the Center Director, CDRH
Innovation Pathway (7 min)Murray Sheldon, MD
Associate Director for Technology,
Office of the Center Director, CDRH
Participant In-Put (10 min) 
9:45 AM-10 AMBreak 
10:00 AM-11:10 AMSession 2: HUD / HDE DiscussionVictoria Wagman (Moderator)
HUD Overview (10 min)Eric Chen, MS
Director, Humanitarian Use Devices Program, OOPD
Overview of HDEs (10 min)Nicole Wolanski
IRB Oversight Issues (10 min)Robert “Skip” Nelson, MD, PhD
Lead Medical Officer, OPT
Moderated Discussion (40 min) 
11:10 AM-11:30 AMSession 3:  Engineering ConsiderationsEric Chen, M.S (Moderator)
Engineering Considerations (10 min)Christy Foreman, MS
Director, Office of Device Evaluation, CDRH
Moderated disussion (20 min) 
11:30 AM-12:45 PMLunch (Moderators from various review divisions)Obtain Lunches (15 minutes) (Lunches will be available for purchase)

Lunchtime Discussion with CDRH Review Division Representatives
12:45 PM-2:00 PMSession 4:  Clinical Trials Issues Panel(Moderator TBD)
Trial Design Considerations (10 min)John Laschinger, MD
Medical Officer, Structural Heart Devices Branch, CDRH
Extrapolation Issues (15 min)Laura Thompson, PhD
General Surgical Devices Branch
Role for Patient Group Registries? (10 min)Steve Groft, PharmD
Director, Office of Rare Diseases, NIH
Moderated Discussion (40 minutes) 
2:00 PM-2:45 PMSession 5:  Needs AssessmentDebra Lewis and Eric Chen (Moderators)
Needs Assessment, Who/ What/ When/ Where/ How? (15 min)Gayatri Rao, MD, JD
Group Discussion with the Rare Disease Devices Needs Assessment Team and Participant In-Put (30 min) 
2:45 PM-3:00 PMBreak 
3:00 PM-3:30 PMSession 6:  Diagnostic DevicesMarkham Luke (Moderator)
Considerations for Diagnostics (15 min)Alberto Gutierrez, MD
Director, Office of In Vitro Diagnostics, CDRH
Moderated Discussion (15 minutes) 
3:30 PM-4:45 PMSession 7:  What Could be Done?...Incentives and OtherwiseJacqueline Ryan (Moderator)
AAP PerspectiveTamar Magarik Haro
AdvaMed PerspectiveMichael C. Morton
V.P. Regulatory Affairs of Medtronic, Inc.
NORD PerspectiveDiane Dorman
NICHD PerspectiveSteve Hirschfeld, MD, PhD, CAPT, USPHS
Associate Director for Clinical Research, NICHD
Participant input (55 min) 
4:45 PM-5:00 PMSession 8:  Wrap-Up / Closing RemarksJacqueline Francis, MD, MPH / Linda Ulrich, MD

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Contact Us

For questions regarding workshop content please contact: Carol Krueger, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Room 3663, Silver Spring, MD 20993, 301-796-3241,

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