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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 3-171
Standard
ASTM F2514-21
Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
Scope/Abstract
1.1 Purpose-This guide establishes recommendations and considerations for the development, verification, validation, and reporting of structural finite element models used in the evaluation of the performance of a metallic vascular stent design undergoing uniform radial loading. This standard guide does not directly apply to non-metallic or absorbable stents, though many aspects of it may be applicable. The purpose of a structural analysis of a stent is to determine quantities such as the displacements, stresses, and strains within a device resulting from external loading, such as crimping or during the catheter loading process, and in-vivo processes, such as expansion and pulsatile loading. ...
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
Unclassified Coronary Drug-Eluting Stent Class 3 NIQ
Unclassified Iliac Covered Stent, Arterial Class 3 PRL
Unclassified Stent, Carotid Class 3 NIM
Unclassified Stent, Coronary Class 3 MAF
Unclassified Stent, Iliac Class 3 NIO
Unclassified Stent, Iliac Vein Class 3 QAN
Unclassified Stent, Renal Class 3 NIN
Unclassified Stent, Superficial Femoral Artery Class 3 NIP
Unclassified Stent, Superficial Femoral Artery, Drug-Eluting Class 3 NIU
Unclassified System, Endovascular Graft, Aortic Aneurysm Treatment Class 3 MIH
Unclassified System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Class 3 PFV
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, Issued April 2010.

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 Contacts
 Jason Weaver
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2504
  Jason.Weaver@fda.hhs.gov
 Finn Donaldson
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  301-796-9579
  Finn.Donaldson@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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