Medical Devices

Public Meeting - FDA/NIH/NSF Workshop on Computer Models and Validation for Medical Devices, June 11-12, 2013

The Food and Drug Administration (FDA) is announcing its 5th Public Workshop on Computer Methods for Medical Devices titled “FDA/NIH/NSF Workshop on Computer Models and Validation for Medical Devices.”

The purpose of the meeting was to present, discuss and receive input on an FDA library of models and data relevant to medical devices and to discuss a strategy to assess the credibility of computer models used to evaluate medical devices.


Date, Time and Location:

This meeting was held June 11-12, 2013, beginning at 8:30 a.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993

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Webcast Archive

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Meeting Summary

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Draft Agenda

This agenda is subject to change.

Day 1June 11, 2013
FDA Library of Models and Simulations
8:00-9:00Registration
9:00-9:30Welcoming Remarks
Donna Lochner, Office of Science and Engineering Laboratories, FDA
Michelle McMurry-Heath, Office of the Center Director, CDRH, FDA
9:30-10:15Keynote Speaker
Experience with IMAG and MSM communities: a 10 year partnership to advance biomedical modeling and simulation
Grace C.Y. Peng, PhD
National Institute of Biomedical Imaging and Bioengineering/ National Institutes of Health
Chair, Interagency Modeling and Analysis Group and The Multiscale Modeling Consortium
With Q&A
10:15-10:30Break
10:30-11:00Invited Speaker
Medical Device Development Tools
Kathryn O’Callaghan
Office of the Center Director, Center for Devices and Radiological Health, FDA
With Q&A
11:00-11:30FDA Presentation - Digital Library Content
Requirements and sharing of models and simulations
Leonardo Angelone
Jessica Hernandez

Office of Science and Engineering Laboratories, FDA
11:30-12:30Lunch
12:30-1:45Discussion: Digital Library Content
Moderator:  Christopher Forrey, Office of Science and Engineering Laboratories, FDA
1:45-2:00Audience questions to Panel
2:00-2:30FDA Presentation-Digital Library Scientific Review
Who, What, When, Where, How?
James Coburn
Office of Science and Engineering Laboratories, FDA
2:30-2:45Break
2:40-4:00Discussion:  Digital Library Scientific Review
Moderator: Zane Wyatt, Office of Device Evaluation, FDA
4:00-4:15Audience questions to Panel
4:15-4:30Break
4:30-5:00Day 1 Recap & Discussion
Day 2June 12, 2013
Strategy to Assess Credibility of Models and Simulation
8:00-8:30Registration
8:30-8:40Welcoming Remarks
Tina Morrison, Office of Device Evaluation, FDA
8:40-9:10Invited Speaker
The ASME V&V40 Subcommittee & Guide
Carl Popelar, PhD
Manager, Mechanics and Materials, Southwest Research Institute
9:10-9:30Presentation of Exercise #1 and discussion questions
From the pre-workshop assignment
9:30-11:00Discussion: Risk Assessment Matrix
Moderators: Ashley Boam, Office of Device Evaluation, FDA
Richard Swift, Med Institute
With time allotted for audience questions
11:00-11:30Invited Speaker
Adapting NASA-STD-7009 to Assess the Credibility of Biomedical Models and Simulations
Lealem Mulugeta
Project Scientist, NASA Digital Astronaut Project
11:30-12:30Lunch
12:30-1:00Illustrative Example from Exercise #2 and discussion questions
From the pre-workshop assignment
1:00-2:30Discussion: Credibility Assessment Matrix-Part 1
Structure and Function of the CAM
Moderators: Finn Donaldson, Office of Science and Engineering Laboratories, FDA
Dawn Bardot, Heart Flow
With time allotted for audience questions
2:30-3:00Break
3:00-3:30Invited Speaker
A Model for Measuring Model Credibility
Matthew Myers, PhD
Office of Science and Engineering Laboratories, FDA
3:30-5:00Discussion: Credibility Assessment Matrix-Part 2
Credibility Level Determination
Moderators: Matthew Myers, Office of Science and Engineering Laboratories, FDA
Jeffrey Bischoff, Zimmer
With time allotted for audience questions
5:00-5:30Day 2 Recap and Next Steps

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Contact Us

For questions regarding meeting content please contact:

Donna R. Lochner
Associate Director
Office of Science and Engineering Laboratories
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: (301) 796-6309
Fax: (301) 796-9959
e-mail: donna.lochner@fda.hhs.gov

Or

Tina M. Morrison, Ph.D.
Mechanical Engineer
Division of Cardiovascular Devices
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: (301) 796-6310
Fax: (301) 847-8114
e-mail: tina.morrison@fda.hhs.gov

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