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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 5-140
Standard
ASME  V&V 10-2019
Standard for Verification and Validation in Computational Solid Mechanics
Scope/Abstract
The purpose of this Standard is to provide the CSM community with a common language, a conceptual framework, and general guidance for implementing the processes of computational model V&V. To this end, this Standard includes a glossary of terms, figures illustrating the recommended overall approach to V&V activities, and discussions of factors that should be considered when developing and executing a V&V program. In creating this Standard, the ASME V&V 10 Subcommittee benefited from the earlier contributions to the field of V&V by other groups, especially AIAA (ref. [2]), as well as by Oberkampf et al. (ref. [3]) and Thacker et al. (ref. [4]).

Three related documents (see Preface) have been or are in the process of being generated that provide details not presented in this overarching Standard. ASME V&V 10.1 describes a simple example of V&V to illustrate some of the key concepts and procedures presented in this Standard; ASME V&V 10.2 will address uncertainty within the V&V process; and ASME V&V 10.3 will provide an in-depth description of some of the metrics that can be used for validation comparisons and how to apply them.

To maximize the value to the engineering community, the ASME V&V 10 Subcommittee chose to write this Standard from the perspective of V&V for high-consequence computational predictions of complex engineering systems. However, the guidance provided here is also appropriate for simple applications, though it is understood that smaller budgets and lower risks will reduce the scope of the V&V effort. While the concepts and terminology presented here are applicable to all applied mechanics, the focus is on CSM.
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
 Kenneth Aycock
  FDA/CDRH/OSEL
  301-796-7088
  kenneth.aycock@fda.hhs.gov
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.
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