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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 066 Date of Entry 05/25/2026 
FR Recognition Number 3-204
Standard
ISO  5840-3 Second edition 2021-01 [Including AMD1:2025]
Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques [Including: AMENDMENT 1 (2025)]
Scope/Abstract
This document is applicable to all devices intended for implantation as a transcatheter heart valve substitute.
This document is applicable to transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.
This document establishes an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests can include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.
This document defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.
This document includes considerations for implantation of a transcatheter heart valve substitute inside a pre-existing prosthetic device (e.g. valve-in-valve and valve-in-ring configurations).
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FDA recognition of ISO 5840-3 Second edition 2021-01 [Rec# 3-173] will be superseded by recognition of ISO 5840-3 Second edition 2021-01 [Including AMD1:2025] [Rec# 3-204]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-173] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 3-173] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
N/A Aortic Valve, Prosthesis, Percutaneously Delivered Class 3 NPT
N/A Prosthesis, Mitral Valve, Percutaneously Delivered Class 3 NPU
N/A Pulmonary Valve Prosthesis Percutaneously Delivered HDE NPV
Relevant FDA Guidance and/or Supportive Publications*
Fernando A, Hillebrenner M, Stewart S, Swain J, Hampshire V, Zuckerman B. U.S. Regulatory Considerations for Heart Valves Implanted by Minimally Invasive Surgery. Cardiovasc Eng Technol 2011; 2(2): 62-5.

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
 Changfu Wu
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIB/
  301-796-6086
  Changfu.Wu@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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