Medical Devices
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 am | Opening Remarks Jeff Shuren, MD, JD, Director, FDA/CDRH |
| 8:35-9:05 am | Introductions: 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 am | The Challenges of Medical Device & Surgical Procedure Regulation William Maisel, MD, MPH, Deputy Director for Science, FDA/CDRH |
| 9:25-9:45 am | Paradigms for Evaluating Innovation in Medical Devices |
| 9:45-9:55 am | Conceptual Framework for Evidence Evaluation for Devices & Procedures |
| 9:55-10:15 am | IDEAL: What it is and Why it is Relevant? |
| 10:15 -10:45 am | THINK 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 am | FDA’s Premarket Evaluation: Methodological Opportunities of the New FDA Initiatives |
| 11:20-11:30 am | The 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 pm | THINK 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 pm | Current Practice in US |
| 1:40-2:00 pm | Current Practice in EU |
| 2:00-3:00 pm | THINK 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 pm | Contemporary Post-Market for Devices-MDEpiNet |
| 3:40-4:00 pm | IDEAL Recommendations for Stage 4 |
| 4:00-5:15 pm | SMALL GROUP DISCUSSIONS OF POST-MARKET ISSUES 3 group breakout sessions |
| 5:15-5:45 pm | Report from Small Group Discussions |
| 5:45 pm | ADJOURN |
Transcript
Related Information
- Blazeby J, Blencowe N, Titcomb D, Metcalfe C, Hollowood A, and Barham C (2011).
Demonstration of the IDEAL recommendations for evaluating and reporting surgical innovation in minimally invasive oesophagectomy.
British Journal of Surgery, 98:544-551. - Barkun J, Aronson J, Feldman L, Maddern G, and Strasberg S (2009).
Surgical Innovation and Evaluation 1: Evaluation and stages of surgical innovations.
The Lancet, 374:1089-96. - Ergina P, Cook J, Blazeby J, Boutron I, Clavien P, Reeves B, and Seiler C (2009).
Surgical Innovation and Evaluation 2: Challenges in evaluating surgical innovation.
The Lancet, 374:1097-104. - McCulloch P, Altman D, Campbell B, Flum D, Glasziou P, and Marshall J (2009).
Surgical Innovation and Evaluation 3: No surgical innovation without evaluation: the IDEAL recommendations.
The Lancet, 374:1105-12. - Sedrakyan A, Marinac-Dabic D, Normand SL, Mushlin A, Gross T (2010).
A framework for evidence evaluation and methodological issues in implantable device studies.
Med Care, 48(6 Suppl):S121-8.
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.
