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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 059 Date of Entry 12/19/2022 
FR Recognition Number 2-296
Standard(Included in ASCA)
ISO  10993-10 Fourth edition 2021-11
Biological evaluation of medical devices - Part 10: Tests for skin sensitization
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization.
This document includes:
- details of in vivo skin sensitization test procedures;
- key factors for the interpretation of the results.
NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 4 General principles - Step-wise approach

Annex C
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:
Clause 4 and Annex C are in conflict with an existing published FDA guidance. See Section B (page 20) of the guidance listed below, which states "With the advancement of scientific knowledge regarding the basic mechanisms of tissue responses, FDA agrees with the ISO 10993-1:2009 revision focus on minimizing the 'number and exposure of test animals by giving preference to chemical constituent testing and in vitro models, in situations where these methods yield equally relevant information to that obtained from in vivo models.'"
ASCA Notes
The following test methods are included in the ASCA pilot program:
Guinea Pig Maximization Sensitization, in conjunction with ASTM F720-17 (recognition number: 2-256);
Closed Patch Sensitization.
Transition Period
FDA recognition of ISO 10993-10 Third Edition 2010-08-01 [Rec# 2-174] will be superseded by recognition of ISO 10993-10 Fourth edition 2021-11 [Rec# 2-296]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-174] until December 22, 2024. After this transition period, declarations of conformity to [Rec# 2-174] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies
Relevant FDA Guidance and/or Supportive Publications*
ISO 10993-12:2021 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.

For further information on use of the LLNA method see FDA January 13, 2011 letter to RADM Stokes, National Toxicology Program regarding FDA use of the ICCVAM methods for LLNA.

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 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
 Chandramallika (Molly) Ghosh
 Shelby Skoog
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.