| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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058
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Date of Entry 05/30/2022
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FR Recognition Number
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8-590
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| Standard | |
ISO TS 17137 Third edition 2021-09
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants |
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Scope/AbstractThis document establishes design evaluation requirements and recommendations for absorbable cardiovascular implants used to treat vessels and/or the vascular space within the circulatory system, including the heart and all vasculature. This document is intended to supplement device-specific standards by providing guidelines specific for either absorbable implants or components, or both.
This document is applicable to implants in direct contact with the cardiovascular system, where the intended action is upon the circulatory system. This document 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 this document if they do not affect the absorption aspects of the implant. A cardiovascular absorbable implant can 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.
NOTE 1 Some aspects of absorbable components of cardiovascular device-drug combination products (e.g. coatings) in their connection with drug-related aspects of the device are addressed in ISO 12417-1.
NOTE 2 An explanation of the nomenclature of absorb, degrade and related terms can be found in Annex A. |
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| Extent of Recognition
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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. |
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Transition Period
| FDA recognition of ISO/TS 17137 Second edition 2019-09 [Rec# 8-525] will be superseded by recognition of ISO/TS 17137 Third edition 2021-09 [Rec# 8-590]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-525] until July 9, 2023. After this transition period, declarations of conformity to [Rec# 8-525] will not be accepted. |
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," Issued September 2020.
ISO 10993-1:2019 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
