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U.S. Department of Health and Human Services

About FDA

Code Sharing of Device Related Software

Description: CDRH develops software programs as part of regulatory science research projects. A significant number of these software programs have utility to medical device industry as well as academia. There are issues related to transfer of these programs and tools to regulated industry. Some of these issues are: intellectual property ownership, regulatory impact and liability of ownership. The goal of this project is to develop a system where issues mentioned above are resolved and the distribution of CDRH-developed software programs is expedited.

Accomplishment: Through the code sharing initiative, CDRH engineers have developed several computational methods to facilitate the development and evaluation of medical devices. For example, the Therapeutic Python script language project (TheraPy) is a collection of Python scripts developed to model the evolution of chemical and physical inhomogeneities in drug-polymer composites, available at: http://matforge.org/redmine/projects/therapy/wiki. A workshop on implementation has been held and the software has been used in industrial R&D. The Monte Carlo Graphics Processing Unit (MC-GPU) is X-ray imaging system simulation code implementing an accurate Monte Carlo x-ray transport algorithm that can be efficiently executed in a state-of-the-art Graphics Processing Unit (GPU). MC-GPU generates clinically-realistic projection or tomographic images of the human anatomy that can be used in the assessment and optimization of imaging systems. This code is available at: http://code.google.com/p/mcgpu

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Identify all software tools under development in OSEL that are ready for code sharing

2/28/2010

Completed 2/28/2010

B. Identify issues and differences in all software tools

3/31/2010

Completed 3/31/2010

C. Identify different methods of code sharing suitable for all or selected software tools

4/30/2010

Completed 4/30/2010

D. Have in place policies and procedures for code sharing and dissemination of software tools

7/31/2010

Completed 6/15/2010

E. Have in place templates for Office/Center clearance and web posting of documents for open source access and modification

9/30/2010

Completed 9/30/2010

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.