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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 059 Date of Entry 12/19/2022 
FR Recognition Number 5-141
ASME  V&V 20-2009 (R2021)
Standard for Verification and Validation in Computational Fluid Dynamics and Heat Transfer
The objective of this Standard is the specification of a verification and validation approach that quantifies the degree of accuracy inferred from the comparison of solution and data for a specified variable at a specified validation point. The approach, proposed by Coleman and Stern [1], uses the concepts from experimental uncertainty analysis [2-4] to consider the errors and uncertainties in both the solution and the data.

The scope of this Standard is the quantification of the degree of accuracy of simulation of specified validation variables at a specified validation point for cases in which the conditions of the actual experiment are simulated. Consideration of solution accuracy at points within a domain other than the validation points (e.g., interpolation/ extrapolation in a domain of validation) is a matter of engineering judgment specific to each family of problems and is beyond the scope of this Standard.

Fluid dynamics and heat transfer are the areas of engineering and science that are specifically addressed, but the validation approach discussed is applicable in other areas as well. Discussion and examples are centered on models using partial differential equations, but simpler models also fall within the purview of the validation approach.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Reporting of Computational Modeling Studies in Medical Device Submissions, Issued September 2016.

ASME V&V40-2018 Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices (Recognition Number: 5-122).

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Brent Craven
Standards Development Organization
ASME American Society of Mechanical Engineers https://www.asme.org/
FDA Specialty Task Group (STG)
General I (QS/RM)
*These are provided as examples and others may be applicable.