Providing valid scientific evidence is essential for FDA medical device applications. Now there’s a new FDA Draft Guidance on Computational Modeling and Simulation (CM&S) Studies covering one type of report that is frequently used for this purpose. The recommendations include format, organization and content for these studies. The goal is to assist both industry and the FDA staff with better reporting to benefit the review process, particularly in the areas of consistency and predictability, for better interpretation of the results.
You may be using these types of studies for the following areas:
- fluid dynamics (like shear stress and stagnation calculations in ventricular assist devices)
- solid mechanics (maximum stress locations in a hip implant)
- electromagnetics and optics (radiofrequency dosimetry in magnetic resonance imaging, fluence for fiber optic spectroscopy devices)
- ultrasound propagation (absorbed energy distribution for therapeutic ultrasound)
- thermal propagation (radiofrequency and laser ablation devices)
This draft guidance gives you an outline of the sections of such studies when used for the premarket report, as envisioned by the FDA:
- Executive Summary
- Background/Introduction
- System Configuration
- Governing Equations/Constitutive Laws
- System Properties
- System Conditions
- System Discretization
- Numerical Implementation
- Validation
- Results
- Discussion
- Limitations
- Conclusions
Then five Appendices cover the major subject areas (mentioned above) that these CM&S studies are used to support.
If you provide or are going to provide this type of study to support the submission of your medical device to the FDA, you’ll find this draft guidance on computational modeling to be an important window into how the FDA will review and evaluate your findings. Since it is a draft document, there are 90 days available from the release date of the guidance (January 17, 2014) for public comment. This means that if you have any area of this document that concerns you, you are welcome to provide input to the FDA before the document is finalized.
Of course, the FDA guidance documents are issued as aids to both staff and industry in how the department handles specific topics. So the use of these publications can provide you with material assistance in organizing your submissions for improved handling by the FDA.
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