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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 051 Date of Entry 01/14/2019 
FR Recognition Number 3-138
Standard
ASTM  F2942-13
Standard Guide for the In Vitro Axial, Bending, and Rotational Durability Test of Vascular Stents
Scope/Abstract
This guide includes three separate cyclic deformation durability guides related to vascular stents: bending, axial, and torsional.This guide does not address flat plate, local crush durability, or multi-mode testing.
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.
Transition Period
FDA recognition of ASTM F2942-13 [Rec# 3-138] will be superseded by recognition of ASTM F2942-19 [Rec# 3-189]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-138] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 3-138] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
N/A Stent, Coronary Class 3 MAF
N/A System, Endovascular Graft, Aortic Aneurysm Treatment Class 3 MIH
N/A Stent, Carotid Class 3 NIM
N/A Stent, Renal Class 3 NIN
N/A Stent, Iliac Class 3 NIO
N/A Stent, Superficial Femoral Artery Class 3 NIP
N/A Coronary Drug-Eluting Stent Class 3 NIQ
N/A 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 Contact
 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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