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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 2-290
Standard
ISO /TS 37137-1 First edition 2021-03
Biological evaluation of absorbable medical devices - Part 1: General requirements.
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).
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.
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.
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FDA recognition of ISO/TR 37137 First edition 2014-05-15 [Rec# 2-241] will be superseded by recognition of ISO/TS 37137-1 First edition 2021-03 [Rec# 2-290].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.
Public Law, CFR Citation(s) and Procode(s)*
21 CFR 58 Good Laboratory Practice for Nonclinical Laboratory Studies
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.
FDA Technical Contacts
 Berk Oktem
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-3542
  Berk.Oktem@fda.hhs.gov
 Shelby Skoog
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-2800
  Shelby.Skoog@fda.hhs.gov
 Scott McNamee
  FDA/OC/CDRH/OPEQ/CSPS/
  301-796-5800
  scott.mcnamee@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Biocompatibility
*These are provided as examples and others may be applicable.
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