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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 058 Date of Entry 05/30/2022 
FR Recognition Number 3-182
Standard
ASTM F3036-21
Standard Guide for Testing Absorbable Stents
Scope/Abstract
1.1 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.
Transition Period
FDA recognition of ASTM F3036-13 [Rec# 3-137] will be superseded by recognition of ASTM F3036-21 [Rec# 3-182]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-137] until July 9, 2023. After this transition period, declarations of conformity to [Rec# 3-137] will not be accepted.
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*
Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, issued April 2010.

Guidance for Industry and FDA Staff: General Considerations for Animal Studies for Cardiovascular Devices, issued July 2010.

Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems: Guidance for Industry and Food and Drug Administration Staff, issued August 2015.

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
 Shiril Sivan
  FDA/OC/CDRH/OSEL/DAM/
  240-402-4125
  Shiril.Sivan@fda.hhs.gov
 Nandini Duraiswamy
  FDA/OC/CDRH/OSEL/DAM/
  301-796-5154
  Nandini.Duraiswamy@fda.hhs.gov
 Samuel Raben
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  240-402-6629
  Samuel.Raben@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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