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Medical Devices

Public Workshop - Post Approval Studies 2012 Workshop: Design, Methodology, and Role in Evidence Appraisal throughout the Total Product Life Cycle, August 30, 2012

The Food and Drug Administration (FDA) is announcing the following public workshop entitled Post Approval Studies 2012 Workshop: “Design, Methodology, and Role in Evidence Appraisal throughout the Total Product Life Cycle.” The topics of discussion will include the following: post-approval studies in the Total Product Life Cycle, best practices and improvement of implementation strategies for post-approval studies, public health impact and innovative methodologies for evidence appraisal. FDA is holding this public workshop to provide update and obtain stakeholders input on Post-Approval Studies ordered at the time of device approval.

Date, Time and Location

This workshop will be held August 30, 2012, beginning at 8:00 am 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 workshop will be webcasted.


An online archive of the webcast for this event is available:


Time Topic Speakers
8:00-8:05Call for Order and IntroductionsNilsa Loyo-Berríos, FDA
8:05-8:15Welcome and Goals for the DayDanica Marinac-Dabic, FDA
8:15-8:30Welcome Remarks and Perspective on Post-Approval StudiesThomas Gross, FDA
 Session I: PAS in the Total Product Life Cycle  
8:30-8:40PAS Program OverviewNilsa Loyo-Berríos, FDA
8:40-8:50Premarket Factors Leading to PAS QuestionsRandall Brockman, FDA
8:50-9:00Use of PAS Data Throughout Device Life-CycleDaniel Caños, FDA
9:00-9:15New Postmarket Initiatives and the PAS ProgramDanica Marinac-Dabic, FDA
9:15-10:00Panel Discussion  
 Session II: Best Practices and Improvement of PAS Implementation Strategies  
10:10-10:20FDA Perspective on Opportunities for PAS Studies ImplementationVeronica Sansing, FDA
10:20-10:30Industry Perspective on Opportunities for PAS Studies ImplementationRoberta Dressen, Medtronic
10:30-10:40Innovative Methodologies, Data Sources and Leveraging Existing InfrastructureSharon-Lise Normand, Harvard University
10:40-10:50Use of International Infrastructure and DataArt Sedrakyan, Cornell University
10:50-11:00Best Practices and the Role of PartnershipsDavid Naftel, University of Alabama at Birmingham
11:00-11:45Panel Discussion  
11:45-12:00Small Group Discussions – Background Mary Beth Ritchey, FDA
 Session III: PAS Impact on Public Health and Medical Device Innovation
1:00-2:00Small Group Discussion: PAS Impact on Public Health
 Small Group Discussion: PAS Program and Medical Device Innovation  
2:20-2:45Small Groups Summary Reports (5 minutes each) 
 Session IV: Opportunities for Innovative use of PAS Data  
2:45-3:00Improving Trial Design: FDA Perspective on using PAS Data for Bayesian Priors, Historical Controls, OPC, etc.Laura Thompson, FDA
3:00-3:15Innovative Approaches to Evaluate Rare Outcomes in PASJoAnn Kuhne, Sientra
3:15-3:30Academia, Research, MDEpiNet Perspective: PAS as Part of Larger StudyDouglas Packer, Mayo Clinic
3:30-3:45Patient Advocate Perspective: PAS Data to Support Health Care Decision MakingMarlena Vega, Patient Representative
3:45-4:00CMS Perspective: Reimbursement Decisions and Collaborative ReviewJyme Schafer, CMS/OCSQ
4:00-4:45Panel Discussion  
 Wrap-up: Moving Forward and Next Steps  
4:45-5:00Vision for the Future of PAS ProgramDanica Marinac-Dabic, FDA


As of August 28, online registration is closed.

There is no fee to register for the workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.

If you require special accommodations due to a disability, or need additional information regarding registration, please contact Cindy Garris, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Silver Spring, MD 20993, 301-796-5861, FAX: 301-847-8142,


Contact Us

For questions regarding workshop content please contact:

Nilsa Loyo-Berrios, PhD, MSc
Center for Devices and Radiological Health
Food and Drug Administration,
10903 New Hampshire Ave., WO-66 Rm. 3214
Silver Spring, MD 20993
Phone: (301)796-8528


Danica Marinac-Dabic, MD, PhD
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave., WO-66 Rm. 4110
Silver Spring, MD 20993
phone: (301)796-6689

Page Last Updated: 03/13/2014
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