Medical Devices

Public Workshop - Center for Devices and Radiological Health Guidance Development and Prioritization Public Workshop, June 5, 2014

The Food and Drug Administration (FDA) is announcing the Center for Devices and Radiological Health (CDRH) Guidance Development and Prioritization Public Workshop. The topics discussed included CDRH’s guidance development process, guidance development best practices for FDA, CDRH and CDRH stakeholders, and CDRH guidance priorities and priority development.


Date, Time and Location

This meeting was held June 5, 2014, beginning at 9:00 a.m. at the following location:

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

The meeting will be webcast.

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Transcript

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Agenda

TopicSpeakerTime
KeynoteNancy Stade
Deputy Director for Policy, CDRH
9:00-9:20
CDRH Guidance Development ProcessRuth Fischer
Policy Advisor, CDRH
9:20-9:40
Guidance Development Best Practices Overview
CDRH PerspectiveNancy Stade9:40-10:00
FDA PerspectiveLeslie Kux
Assistant Commissioner for Policy, FDA
10:00-10:20
Break10:20-10:35

Stakeholder perspectives

Janet Trunzo
Senior Executive Vice President Technology & Regulatory Affairs, AdvaMed
10:35-10:55
Ralph Hall
Professor, University of Minnesota Law School
10:55-11:15
Paul Brown
Government Relations Manager, National Research Center for Women & Families, Cancer Prevention and Treatment Fund
11:15-11:35
Questions & Comments from Audience11:35-11:50
Lunch11:50-12:50
Guidance Development Best Practices Panel DiscussionNancy Stade (moderator)12:50-1:35
Panelists:
  • Hans Beinke, Head of Regulatory Quality & Clinical Affairs, Siemens / Board Member, The Medical Imaging & Technology Alliance
  • Ralph G. Brindis, MD, MPH, MAAC, FSCAI, Clinical Professor of Medicine, Department of Medicine & the Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco / Senior Medical Officer, External Affairs, American College of Cardiology National Cardiovascular Data Registry
  • Paul Brown, Government Relations Manager, National Research Center for Women & Families / Cancer Prevention and Treatment Fund
  • Ralph Hall, Professor, University of Minnesota Law School
  • Angela Krueger, Acting Associate Director for Guidance & Regulations, Office of Device Evaluation, CDRH
  • Scott McFarland, Policy Advisor, Office of In Vitro Diagnostics & Radiological Health, CDRH
  • Heather S. Rosecrans, Vice President of Regulatory Affairs, Medical Device Manufacturers Association
  • Janet Trunzo, Senior Executive Vice President Technology & Regulatory Affairs, AdvaMed
CDRH Priority DevelopmentPhilip Desjardins
Associate Director for Policy, CDRH
1:35-1:55
Break1:55-2:10
CDRH Guidance Priorities Panel DiscussionNancy Stade (moderator)
Panelists (see above)
2:10-2:55
Questions & Comments from AudienceWorkshop Participants2:55-3:45
ConclusionNancy Stade3:45-4:00

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Webcast Archive

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Contact Us

For questions regarding workshop content please contact Cathy Norcio, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5446, Catherine.Norcio@fda.hhs.gov.

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Page Last Updated: 07/15/2014
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