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U.S. Department of Health and Human Services

Medical Devices

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Public Workshop - Bridging the IDEAL and TPLC Approaches for Evidence Development for Surgical Medical Devices and Procedures, December 2, 2011

The Food and Drug Administration (FDA) is announcing a public workshop entitled, “Bridging the IDEAL and TPLC Approaches for Evidence Development for Surgical Medical Devices and Procedures; Public Workshop”. The purpose of the public workshop is to provide a forum for discussion among FDA, governmental agencies, academia, physicians and various stakeholders to f urther refine and advance the IDEAL initiative (Idea Development Exploration, Assessment and Long-Term Study) and TPLC (Total Product Life Cycle) frameworks related to evidence generation and evaluation for surgical devices and procedures.


Date, Time and Location

This meeting was held on December 2, 2011, beginning at 8:00 a.m.-5:30 p.m., at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center (Great Room, Room 1503)
Silver Spring, MD 20993

The meeting was webcasted.

Agenda

8:15-10:45 am Setting the Stage Introductory Session
8:15-8:35 amOpening Remarks
Jeff Shuren, MD, JD, Director, FDA/CDRH
8:35-9:05 amIntroductions: Danica Marinac-Dabic , MD, PhD, Director, Division of Epidemiology, FDA/CDRH/OSB
Goals for the Day: Peter McCulloch, MD, University of Oxford and Art Sedrakyan, MD, PhD, Cornell University
9:05-9:25 amThe Challenges of Medical Device & Surgical Procedure Regulation
William Maisel, MD, MPH, Deputy Director for Science, FDA/CDRH
9:25-9:45 amParadigms for Evaluating Innovation in Medical Devices
9:45-9:55 amConceptual Framework for Evidence Evaluation for Devices & Procedures
9:55-10:15 amIDEAL: What it is and Why it is Relevant?
10:15 -10:45 amTHINK TANK DISCUSSION: Leveraging the Accumulated Evidence
10:45-11:00 am BREAK
11:00-12:30 pm Premarket Evidence Generation and Evaluation for Surgical Medical Devices
11:00-11: 20 amFDA’s Premarket Evaluation: Methodological Opportunities of the New FDA Initiatives
11:20-11:30 amThe IDEAL Recommendations for Early Phase Studies: Registers for First-In-Man; Prospective Study Design and Reporting Recommendations for Early Phase Studies; Prospective Collaborative Databases
11:30-12:15 pmTHINK TANK DISCUSSION: Optimizing an Integrated Total Product Life Cycle for Devices and Procedures
12:15-1:15 pm LUNCH
1:15-3:00 pm Condition Approval (Licensing with Evaluation)-Similarities and Differences from Post-Approval Study Requirements
1:15-1:40 pmCurrent Practice in US
1:40-2:00 pmCurrent Practice in EU
2:00-3:00 pmTHINK TANK DISCUSSION: What is the Potential Scope of L&E?
3:00-3:15 pm BREAK
3:15-5:45 pm Innovative Approaches for Postmarket Evaluation: At the Cutting Edge
3:15-3:40 pmContemporary Post-Market for Devices-MDEpiNet
3:40-4:00 pmIDEAL Recommendations for Stage 4
4:00-5:15 pmSMALL GROUP DISCUSSIONS OF POST-MARKET ISSUES
3 group breakout sessions
5:15-5:45 pmReport from Small Group Discussions
5:45 pm ADJOURN

Transcript

Related Information

Contact Us

For information regarding the program, contact:

Samantha Jacobs,
Food and Drug Administration, Center for Devices and Radiological Health
10903 New Hampshire Ave., Bldg. 66 Rm. 4113
Silver Spring, MD 20993
(301) 796- 6897
Email: Samantha.jacobs@fda.hhs.gov;

OR

Danica Marinac-Dabic, MD, PhD
Food and Drug Administration, Center for Devices and Radiological Health
10903 New Hampshire Ave. , Bldg. 66, Rm. 4113
Silver Spring, MD 20993
(301) 796-6689
Email: danica.marinac-dabic@fda.hhs.gov.