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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 043 Date of Entry 06/27/2016 
FR Recognition Number 3-143
ISO  12417 First edition 2015-10-01
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products
ISO 12417-1:2015 specifies requirements for vascular device-drug combination products (VDDCPs) based upon current technical and medical knowledge. VDDCPs are medical devices with various clinical indications for use in the human vascular blood system. A VDDCP incorporates, as an integral part, substance(s) which, if used separately, can be considered to be a medicinal substance or product (drug substance, drug product) but the action of the medicinal substance is ancillary to that of the device and supports the primary mode of action (PMOA) of the device. With regard to safety, this part of ISO 12417 outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging, and information supplied by the manufacturer. For implanted products, this International Standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This International Standard should also be considered as a supplement to relevant device-specific standards, such as the ISO 25539‑series specifying requirements for endovascular devices. Requirements listed in this part of ISO 12417 also address VDDCPs that are not permanent implants.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 1.0, 2nd paragraph after the note: Exclude the following phrases "whose PMOA is; and, (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)."
Clause 4.3 Intended clinical location, h) intracerebral.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
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. General Considerations for Animal Studies Intended to Evaluate Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued March 2023.

2. ASTM F3320-18 Standard Guide for Coating Characterization of Drug Coated Balloons.

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
 Hetal Patel
 Eleni Whatley
 Kenneth Cavanaugh
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.