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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 3-142
Standard
ISO /TS 17137 First edition 2014-05-15
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants.
Scope/Abstract
ISO/TS 17137:2014 outlines design verification and validation considerations for absorbable cardiovascular implants.

ISO/TS 17137:2014 is applicable to implants in direct contact with the cardiovascular system, where the intended action is upon the circulatory system. ISO/TS 17137:2014 does not address the specific evaluation of issues associated with viable tissues, viable cells, and/or implants with non-viable biological materials and their derivatives. Additionally, procedures and devices used prior to and following the introduction of the absorbable cardiovascular implant (e.g. balloon angioplasty devices) are excluded from the scope of ISO/TS 17137:2014 if they do not affect the absorption aspects of the implant. A cardiovascular absorbable implant may incorporate substance(s) which, if used separately, can be considered to be a medicinal product (drug product) but the action of the medicinal substance is ancillary to that of the implant and supports the primary mode of action of the implant.

Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
Section 3.4 Terms and definitions leachable
Figure 1 Life cycle of one single device/implant
Section 5.2.3 Summary of in vitro evaluation steps: Equilibrium
Section 5.6.1 Biocompatibility: General considerations paragraph 2
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.

Section 3.4, Section 5.2.3, and Section 5.6.1 conflict with an existing published final guidance, see section A and Attachment G of the guidance listed below.

Figure 1 is in conflict with an existing regulation, see regulation listed below.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
Unclassified Coronary Drug-Eluting Stent Class 3 NIQ
Unclassified Stent, Carotid Class 3 NIM
Unclassified Stent, Coronary Class 3 MAF
Unclassified Stent, Iliac Class 3 NIO
Unclassified Stent, Renal Class 3 NIN
Unclassified Stent, Superficial Femoral Artery Class 3 NIP
Unclassified System, Endovascular Graft, Aortic Aneurysm Treatment Class 3 MIH
21 CFR 820.3 (z)
Relevant FDA Guidance and/or Supportive Publications
Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process' - Guidance for Industry and Food and Drug Administration Staff, Issued June 2016.
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Cardiovascular
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