| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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056
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Date of Entry 06/07/2021
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FR Recognition Number
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2-290
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| Standard | |
ISO /TS 37137-1 First edition 2021-03
Biological evaluation of absorbable medical devices - Part 1: General requirements. |
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Scope/Abstract| This document specifies the requirements for the evaluation of absorbable medical devices during a biological risk assessment based on ISO 10993-1, including a clarification of the terms "absorb", "degrade" and other related terms (see Annex A). |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
| Reference to ISO 10993-1:2018, Annex A in Clause 8.2 a) and Clause 8.11. |
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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.
This standard is recognized in part because:
Reference to ISO 10993-1:2018, Annex A in Clause 8.2 a) and Clause 8.11 are in conflict with an existing published final guidance, see Attachment A, Table A1 of the guidance listed below. |
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Transition Period
| FDA recognition of ISO/TR 37137 First edition 2014-05-15 [Rec# 2-241] will be superseded by recognition of ISO/TS 37137-1 First edition 2021-03 [Rec# 2-290]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-241] until July 9, 2023. After this transition period, declarations of conformity to [Rec# 2-241] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| 21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies |
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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.
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. |
