| 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
|
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 |
| 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.
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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
