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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Recognition 07/15/2019 
FR Recognition Number 3-137
Standard
ASTM F3036-13
Standard Guide for Testing Absorbable Stents
Scope/Abstract
This Guide covers select physical and mechanical characterizations of vascular stents with one or more absorbable components. Such absorbable stents (also referred to as vascular scaffolds) are used to provide temporary luminal support of the coronary and peripheral vasculature following interventional revascularization procedures. This Guide covers devices that are fabricated from one or more degradable polymers and/or metals (from this point on referred to as "absorbable"). This Guide provides a framework for evaluating the change in select physical and mechanical characteristics of absorbable stents from manufacture through their intended degradation in vivo. Specific testing recommendations are limited to existing ASTM standards for stent evaluation.
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 Stent, Carotid Class 3 NIM
Unclassified Stent, Coronary Class 3 MAF
Unclassified Stent, Iliac Class 3 NIO
Unclassified Stent, Renal Class 3 NIN
Unclassified Stent, Superficial Femoral Artery Class 3 NIP
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
Draft Guidance for Industry: Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies, Issued March 2008.

Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, Issued April 2010.
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FDA Technical Contact
 Finn Donaldson
  FDA/OMPT/CDRH/ODE/DCD/PIDB/
  301-796-9579
  Finn.Donaldson@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Cardiovascular
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