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U.S. Department of Health and Human Services

About FDA

Improving the Use of Computational Fluid Dynamic (CFD) Techniques to Evaluate Performance and Blood Damage Safety in Medical Devices

Description: The Office of Science and Engineering Laboratories’ Division of Solid and Fluid Mechanics (OSEL/DSFM) is leading an international effort to develop guidelines and provide a publicly-accessible repository of experimental data to make computational fluid dynamic (CFD) more effective for evaluating the safety of medical products by industry and FDA. CFD methods for describing flow patterns and fluid forces are increasingly being used in the development and premarket and postmarket evaluations of blood-contacting medical devices. However, this technology has limited usefulness due to the lack of reliable standardized techniques for assessing the validity and limitations of CFD simulations, and their predictions of blood damage. This project will make the necessary data and standards available for the use of this important tool.

Briefing Status: DELAYED

Prior Briefing Status: DELAYED

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Update publicly-accessible data repository ( https://fdacfd.nci.nih.gov) with publications and reports on benchmark fluid flow patterns for future computational fluid dynamic (CFD) studies that will be submitted to CDRH

4/30/2012

Completed 4/5/2012

B. Provide technical input to the draft American Society of Mechanical Engineers (ASME) standard “Verification and validation for computational modeling of medical devices”

5/30/2012

Completed 5/5/2012

C. Complete study of Blood Pump Model

11/30/2012

Delayed

1. Complete blood damage protocol for inter-laboratory testing

4/30/2012

Completed 4/30/2012

2. Complete quantitative flow visualization protocol for inter-laboratory testing

5/30/2012

Completed 5/29/2012

3. Complete blood damage inter-laboratory testing

11/30/2012

Delayed

4. Complete quantitative flow visualization inter-laboratory testing

11/30/2012

Delayed

D. Complete study of Nozzle Model

12/31/2012

Delayed

1. Complete assessment of CFD performance in simulations of FDA’s first computational inter-laboratory study

3/31/2012

Completed 3/30/2012

2. Complete analysis of inter-laboratory blood damage testing

8/31/2012

Completed 8/31/2012

3. Submit journal article on inter-laboratory CFD studies with sudden contraction at inlet

12/31/2012

Delayed

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.