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The Food and Drug Administration (FDA) is announcing a public workshop entitled “Towards Good Simulation Practices in Health Technologies.”  The purpose of this public workshop is to discuss modeling and simulation practices currently used in health technologies by industry and to develop a framework for evaluating and assessing the utility of computational modeling and simulation in health technologies.  The key topics to be discussed are the role of computational modeling and simulation in the regulatory evaluation of health technologies and current simulation practices, with the goal of gathering input to inform the development of good simulation practice recommendations.

• Background
• Date, Time and Location
• Comments
• Reference
• Contact

BACKGROUND

Traditionally, bench testing, in vivo pre-clinical studies, and clinical trials have been the main sources of evidence generated prior to marketing medical devices in the U.S.  In recent years, however, computational modeling has become an increasingly powerful tool for evaluating medical devices, complementing bench, in vivo and clinical methods (Ref. 1).  Moreover, computational modeling methods (software) are being used more within software platforms, sometimes intended as software as a medical device   (SaMD).  Computational modeling has been identified as a priority by CDRH and FDA because of its reach and potential for driving innovation.  The Office of Science and Engineering Laboratories of CDRH has committed significant resources to transform computational modeling from a valuable scientific tool to a valuable regulatory tool and to develop mechanisms to rely more on digital evidence.  To achieve this objective, FDA Staff and Industry need a framework, or good simulation practices (like good clinical practices), to support the evaluation and utility of computational modeling and simulation in health technologies. 

CDRH is organizing a two-and-a-half-day public workshop in collaboration with industry representatives including presentations, panel discussions, poster and training sessions geared towards informing the development of good simulation practices .  During the meeting, we will discuss specific topics outlined in the Agenda below.

DATE, TIME and LOCATION

TBD

WEBCAST

The public meeting will be webcasted live and the link will be provided in your confirmation email if you registered to view the webcast.  The link for archived webcast will be posted to the webpage for viewing after the meeting.

COMMENTS

Please submit your comments regarding the workshop workshop to https://www.regulations.gov/, Docket No. FDA-2020-N-0750 by May 13, 2020. 

Please refer to the Instructions for submitting comments to the docket to ensure that your feedback is taken into consideration. 

REFERENCE

1) Morrison, T. M., Pathmanathan, P., Adwan, P. and Margerrison, E. (2018) Advancing Regulatory Science with Computational Modeling for Medical Devices at the FDA's Office of Science and Engineering Laboratories, Front. In Med., 5:241, available at https://www.frontiersin.org/articles/10.3389/fmed.2018.00241/full.

The concepts presented in this reference are intended to guide discussions during the upcoming workshop. The reference is not a draft or final guidance and is not intended to propose or implement policy changes or the applicable statutory and regulatory requirements.

CONTACT

For questions regarding workshop content please contact:

Tina Morrison
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 62, Rm. 2210
Silver Spring, MD 20993
301-796-6310
[email protected]