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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 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.
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 2023.

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
 Scott McNamee
  FDA/OC/CDRH/OPEQ/CSPS/
  301-796-5800
  scott.mcnamee@fda.hhs.gov
 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
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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