• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 063 Date of Entry 12/23/2024 
FR Recognition Number 3-193
Standard
ISO  12417-1 Second edition 2024-02
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements
Scope/Abstract
This document specifies requirements for vascular device-drug combination products (VDDCPs).

With regard to safety, this document outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

For implanted products, this document is intended to be used as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This document is intended to be used as a supplement to relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. Requirements listed in this document also address VDDCPs that are not permanent implants.

NOTE 1 Due to variations in the design of combination products covered by this document and due to the relatively recent development of some of these combination products, acceptable standardized in vitro test results and clinical study results are not always available. As further scientific and clinical data become available, appropriate revision of this document can be necessary.

This document applies to delivery systems or parts of the delivery system that are an integral component of the vascular device and that are drug-covered (e.g. drug-covered balloon catheters and drug-covered guidewires).

This document does not apply to devices whose PMOA provide a conduit for delivery of a drug (e.g. infusion catheters), unless they contain a drug component that is intended to have an ancillary action to the device part (e.g. antimicrobial coated infusion catheter). ...
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 12417-1 First edition 2015-10-01 [Rec# 3-143] will be superseded by recognition of ISO 12417-1 Second edition 2024-02 [Rec# 3-193]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-143] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 3-143] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
N/A Scaffold, Infrapopliteal, Absorbable Class 3 NXW
N/A Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter Class 3 OOB
N/A Drug-Coated Peripheral Transluminal Angioplasty Catheter Class 3 PRC
N/A Coronary Drug-Eluting Stent Class 3 NIQ
N/A Stent, Superficial Femoral Artery, Drug-Eluting Class 3 NIU
N/A Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Class 3 NVN
N/A Permanent Defibrillator Electrodes Class 3 NVY
N/A Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode Class 3 OJX
N/A Drug-Eluting Peripheral Transluminal Angioplasty Catheter Class 3 ONU
Relevant FDA Guidance and/or Supportive Publications*
1. ASTM F3320-18 Standard Guide for Coating Characterization of Drug Coated Balloons.

2. AAMI TIR42:2021 Evaluation of particulates associated with vascular medical devices.

3. ISO 10555-1 Third edition 2023-11 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements.

4. ISO 10555-4 Third edition 2023-11 Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters.

5. ISO 25539-2 Third edition 2020-09 Cardiovascular implants - Endovascular devices - Part 2: Vascular stents.

6. ISO 25539-4 First edition 2021-11 Cardiovascular implants - Endovascular devices - Part 4: Application of ISO 17327-1 for coated endovascular devices.

7. ISO 17327-1 First edition 2018-02 Non-active surgical implants - Implant coating - Part 1: General requirements.

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
 Samuel Raben
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  240-402-6629
  Samuel.Raben@fda.hhs.gov
 Hetal Patel
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  240-402-6540
  Hetal.Odobasic@FDA.HHS.GOV
 Eleni Whatley
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIC/
  301-796-6372
  Eleni.Whatley@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Groups (STG)
Cardiovascular (primary)
Neurology
*These are provided as examples and others may be applicable.
-
-