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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 064 Date of Entry 05/26/2025 
FR Recognition Number 3-198
Standard
ISO  25539-3 Second edition 2024-10
Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
Scope/Abstract
This document specifies the requirements for the evaluation of vena cava filter systems (filters and delivery systems) and the requirements with respect to nomenclature, design attributes and information supplied by the manufacturer. Guidance for the development of in vitro test methods is included in Annex D. This document is intended to be used in conjunction with ISO 14630, which specifies general requirements for the performance of non-active surgical implants.
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.

NOTE: The applicability to use previously conducted clinical studies or other alternative sources of data for a subject device is dependent upon differences between the subject device and device previously studied (including differences in technology), intended use, and indications for use. Similarly, the minimum number of investigational sites and maximum number of subjects per site may vary based on factors such as device technology, target population, use environment, and risk assessment. We highly encourage you to contact the review division to discuss clinical evaluation strategies and data requirements for your device before submission of any investigational device exemption or marketing submission.
Transition Period
FDA recognition of ISO 25539-3 First edition 2011-12-01 [Rec# 3-103] will be superseded by recognition of ISO 25539-3 Second edition 2024-10 [Rec# 3-198]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-103] until July 4, 2027. After this transition period, declarations of conformity to [Rec# 3-103] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§870.3375 Filter, Intravascular, Cardiovascular Class 2 DTK
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Cardiovascular Intravascular Filter 510(k) Submissions - Guidance for Industry and Food and Drug Administration Staff, issued November 1999.

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
 Nathan Weidenhamer
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIB/
  --
  Nathan.Weidenhamer@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Cardiovascular
*These are provided as examples and others may be applicable.
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