FDA Says it Wants More Uniformity in One Section of Medical Device Applications

A new draft guidance released by the US Food and Drug Administration (FDA) provides recommendations to sponsors of medical device applications on how they should present the content of computational modeling and simulation studies (CM&S) to better facilitate the "full interpretation and complete review of those studies."

Background

Unlike pharmaceutical and biotechnology products, medical devices are often intended to be subject to physical rigors through extended use over time, either inside the body or in an external environment like a hospital.

To make sure they can withstand those rigors, companies conduct analyses to figure out how the device will hold up in a variety of conditions.

But not all information is created-or presented-equally, FDA explains in its 16 January 2014 draft guidance, Reporting of Computational Modeling Studies in Medical Device Submissions.

"In order for the CM&S studies to provide valid scientific evidence in regulatory submission, specific details need to be included in the report of the studies," FDA wrote.

The Guidance

And that's where the new guidance comes in, establishing an outline of how companies should report their CM&S studies according to a standard of uniformity established in the guidance document.

While the specific details of those tests will vary depending upon the type of device and its intended use, FDA said a general outline and five subject matter appendices contained within the guidance should be sufficient to account for "any modality."

The general outline of any CM&S study should include:

• an executive report summary
• an introduction or background of the device
• system configuration information (details and assumptions, simplifications and rationale)
• equations behind the computational analysis
• an explanation of the physical/chemical/biological properties of the device
• conditions imposed on the computational model (e.g. the conditions it is supposed to test)
• information about how the system was defined (also known as system discretization)
• information regarding the numerical implementation strategy (i.e. how the governing equation was solved)
• information on how the computational model was validated
• an explanation of the results
• a discussion of the results
• an explanation of the limitations of the model, including its assumptions and simplifications
• a summary of the study's conclusions

Five Appendices

The guidance also includes five appendices, which "provide more background, structure, and specific terminology" on the following five areas:

1. Fluid Dynamics and Mass Transport
2. Solid Mechanics
3. Electromagnetics and Optics
4. Ultrasound
5. Heat Transfer

For some devices, more than one appendix will apply, FDA said.

Comments on the draft guidance are due in 90 days.

 

Reporting of Computational Modeling Studies in Medical Device Submissions

Federal Register