Institute of Medicine of the National Academies (IOM)
Meeting 1: Public Health Effectiveness of the FDA 510(k) Clearance Process, March 1, 2010
Agenda
Heather Rosencrans: Understanding the Premarket Notification (510(k)) Process - 510k History from 1976 to 2010 (pdf)
Christy Foreman: Understanding the Premarket Notification (510(k)) Process - Reviewing a 510k Submission (pdf)
Donna Bea Tillman: Understanding the Premarket Notification (510(k)) Process - The 510k Working Group (pdf)
Heather Rosencrans: Understanding the Premarket Notification (510(k)) Process - 510k History from 1976 to 2010 (pdf)
Christy Foreman: Understanding the Premarket Notification (510(k)) Process - Reviewing a 510k Submission (pdf)
Donna Bea Tillman: Understanding the Premarket Notification (510(k)) Process - The 510k Working Group (pdf)
Meeting 2: Public Health Effectiveness of the FDA 510(k) Clearance Process, June 14-15, 2010
Agenda (pdf)
Biographical Information for Invited Speakers and Panelists (pdf)
Webcast: Public Health Effectiveness of the FDA 510(k) Clearance Process, Workshop 1
Philip Phillips: Premarket Notification-A Key Element of US Medical Device Regulation (June 14, 2010) (pdf)
Timothy Ulatowski: FDA's Compliance Infrastructure (June 14, 2010) (pdf)
Josh Makower: The Structure of the MedTech Innovation Ecosystem (June 14, 2010) (pdf)
David Feigal: Impact of the Regulatory Framework on Medical Device Development and Innovation (June 14, 2010) (pdf)
David Jefferys: Comparative Overview of Other Medical Device Regulatory Systems (June 15, 2010) (pdf)
Janet Trunzo: Global Harmonization Task Force (June 15, 2010) (pdf)
Doug Mowen: PwC Medical Technology Innovation Scorecard (June 15, 2010) (pdf)
Biographical Information for Invited Speakers and Panelists (pdf)
Webcast: Public Health Effectiveness of the FDA 510(k) Clearance Process, Workshop 1
Philip Phillips: Premarket Notification-A Key Element of US Medical Device Regulation (June 14, 2010) (pdf)
Timothy Ulatowski: FDA's Compliance Infrastructure (June 14, 2010) (pdf)
Josh Makower: The Structure of the MedTech Innovation Ecosystem (June 14, 2010) (pdf)
David Feigal: Impact of the Regulatory Framework on Medical Device Development and Innovation (June 14, 2010) (pdf)
David Jefferys: Comparative Overview of Other Medical Device Regulatory Systems (June 15, 2010) (pdf)
Janet Trunzo: Global Harmonization Task Force (June 15, 2010) (pdf)
Doug Mowen: PwC Medical Technology Innovation Scorecard (June 15, 2010) (pdf)
Meeting 3: Public Health Effectiveness of the FDA 510(k) Clearance Process, July 28, 2010
Agenda (pdf)
Biographical Information for Speakers and Panelists (pdf)
Webcast: Public Health Effectiveness of the FDA 510(k) Clearance Process Workshop
Kevin Fu: Trustworthy Medical Device Software (pdf)
Rita Redberg: Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices (pdf)
Robert Fischell: Issues with the Present FDA on the Matter of FDA 510(k) Clearance (pdf)
Susan Gardner: Monitoring Device Safety: CDHR's Current System and Vision for the Future (pdf)
William Maisel: Premarket Notification: Analysis of FDA Recall Data (pdf)
Ralph Hall: Using Recall Data to Assess the 510(k) Process (pdf)
Frederick Masoudi: National Cardiovascular Data Registries (pdf)
Paul Varosy: The Veterans Health Administration CART Program (pdf)
Eric Peterson: Use of Registry Data for Postmarket Device Surveillance (pdf)
Frederic Resnic: The DELTA Project (pdf)
Biographical Information for Speakers and Panelists (pdf)
Webcast: Public Health Effectiveness of the FDA 510(k) Clearance Process Workshop
Kevin Fu: Trustworthy Medical Device Software (pdf)
Rita Redberg: Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices (pdf)
Robert Fischell: Issues with the Present FDA on the Matter of FDA 510(k) Clearance (pdf)
Susan Gardner: Monitoring Device Safety: CDHR's Current System and Vision for the Future (pdf)
William Maisel: Premarket Notification: Analysis of FDA Recall Data (pdf)
Ralph Hall: Using Recall Data to Assess the 510(k) Process (pdf)
Frederick Masoudi: National Cardiovascular Data Registries (pdf)
Paul Varosy: The Veterans Health Administration CART Program (pdf)
Eric Peterson: Use of Registry Data for Postmarket Device Surveillance (pdf)
Frederic Resnic: The DELTA Project (pdf)
Reports
Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation - Workshop Report
Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics - Workshop Report
Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years (July 29, 2011)
IOM Report Brief, 510k Clearance Process, July 2011 (pdf)
IOM 510k Clearance Process, Accompanying Letter to the FDA, July 20, 2011 (pdf)
Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics - Workshop Report
Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years (July 29, 2011)
IOM Report Brief, 510k Clearance Process, July 2011 (pdf)
IOM 510k Clearance Process, Accompanying Letter to the FDA, July 20, 2011 (pdf)