Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

053

Date of Entry 12/23/2019 

FR Recognition Number

3-162

Standard

ASTM  F3374-19
Standard Guide for Active Fixation Durability of Endovascular Prostheses

Scope/Abstract

This guide addresses how to conduct in vitro durability testing on active fixation components (AFCs) and attachment mechanisms of endovascular prostheses. It does not address the durability of fixation systems that reside solely within the vessel lumen to resist device migration (e.g, radial force and friction, adhesives, or geometric fit).

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
N/A	System, Endovascular Graft, Aortic Aneurysm Treatment	Class 3	MIH

Relevant FDA Guidance and/or Supportive Publications*

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

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.