Workshops and Conferences
Webinar
FDA Discussion on the Draft 510(k) and Use of Science in Regulatory Decision Making Reports
CDRH/FDA Public Webinar, August 31, 2010 (Audio Playback)
Public Meetings
Incorporation of New Science Into Regulatory Decision making Within the Center for Devices and Radiological Health - February 9, 2010
Federal Register Docket
Tentative Agenda
Case Studies for Discussion
Audio Recording (mp3)
Transcript (pdf)
Tentative Agenda
Case Studies for Discussion
Audio Recording (mp3)
Transcript (pdf)
Strengthening the Center for Devices and Radiological Health’s 510(k) Review Process, February 18, 2010
Federal Register Docket
Federal Register Docket, extension of comment period
Agenda
Transcript (pdf)
Captioned Video Recording
Presentations
Federal Register Docket, extension of comment period
Agenda
Transcript (pdf)
Captioned Video Recording
Presentations
Town Hall Meetings
Town Hall Discussion With the Director of CDRH and Other Senior Center Management, May 18, 2010
Town Hall Discussion With the Director of CDRH and Other Senior Center Management, June 22, 2010
Town Hall Discussion With the Director of CDRH and Other Senior Center Management, October 7, 2010
Public Workshops
Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development, June 24, 2010
Federal Register Docket
Agenda
Transcript
Presentations
Agenda
Transcript
Presentations
Justine Seidenfeld: Engaging Stakeholders in Priority Setting: Real World Experience (pdf)
David Klonoff: Standards & Interoperability for Better Diabetes Technology (pdf)
Richard Ehman: Development and Introduction of New Medical Imaging Technology: Lessons Learned in the Trenches (pdf)
Jack W. Lasersohn: Interagency Collaboration in Support of Medical Device Innovation (pdf)
Bonnie Norman (Director, Quality Assurance & Regulatory Affairs): Home Health: Barriers to Innovation (pdf)
Joseph Smith: Wireless Healthcare: Cost as an Imperative for Innovation (pdf)
Michael Morton: AdvaMed Recommendations on Approaches to Addressing Unmet Public Health Needs (pdf)
David Klonoff: Standards & Interoperability for Better Diabetes Technology (pdf)
Richard Ehman: Development and Introduction of New Medical Imaging Technology: Lessons Learned in the Trenches (pdf)
Jack W. Lasersohn: Interagency Collaboration in Support of Medical Device Innovation (pdf)
Bonnie Norman (Director, Quality Assurance & Regulatory Affairs): Home Health: Barriers to Innovation (pdf)
Joseph Smith: Wireless Healthcare: Cost as an Imperative for Innovation (pdf)
Michael Morton: AdvaMed Recommendations on Approaches to Addressing Unmet Public Health Needs (pdf)
Medical Device User Fee Program Public Meeting, September 14, 2010
Conferences
AMDM/FDA - OIVD 510(k) Workshop, April 21-22, 2009
Prosystem Symposium 2011: European Requirements for Medical Devices October 27 & 28, 2011, San Jose, CA
Description
"New 510(k): Trends, Recent Initiatives, and Looking Ahead," Marta Gaia Zanchi, Medinnovo LLC
"New 510(k): Trends, Recent Initiatives, and Looking Ahead," Marta Gaia Zanchi, Medinnovo LLC
FDA Science Board 2013: June 24, 2013
Report: Protecting the core of CDRH regulatory science in the face of financial and strategic threats (PDF - 699KB)