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Groups Take Issue with FDA’s Computer Modeling Draft


Posted in Regulatory and Compliance by Jamie Hartford on August 7, 2014

By Jim Dickinson

Three trade groups have found fault with FDA's draft guidance on reporting of computational modeling studies in medical submissions, which was issued June 29, 2014.

AdvaMed says there is a need for more consistency among the five subject matter appendices in an FDA draft guidance on reporting of computational modeling studies in medical device submissions. Other general issues with the draft, according to the medtech trade association’s comment letter, are the need for specific details on requirements for commercially available test software versus user-developed software and the benefits of creating a master file for company information that would be common to any submission for the subject matter.

One way to achieve consistency would be to address the common elements in the general section of this guidance and address only the subject matter specific elements in the subject matter appendices,” the letter says.

The Association of Clinical Research Professionals (ACRP) says it congratulates FDA “for providing a concise and complete overview of the report of the computational modeling and/or simulation study. It is now clear how the report should be developed and what key elements are needed to support the use of mathematical modeling and simulation in medical device development and approval.”

The ACRP’s letter says challenges to implementation of this guidance include under-utilization in regulatory submission; the need to bridge the communication gap between modeling scientists within industry, between industry, and with regulators; and the need to pool pre-competitive data from multiple sources to provide comprehensive understanding of human physiology and pharmacology, thus building mechanistic models for medical device development and functions.

The Medical Imaging & Technology Alliance calls on FDA to clarify whether the final guidance can be used to evaluate x-ray systems and virtual phantoms. It also recommends that the agency include more information, including examples, on its perspective as to what constitutes a medical device for the purpose of scope discussion in the guidance. And it recommends that FDA clarify whether other types of physics are included in the framework or if it is limited to multiphysics.

All three stakeholders also provide detailed line-by-line comments, as does Edwards Lifesciences.

Jim Dickinson is MD+DI's contributing editor.

[image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]


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