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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 065 Date of Entry 12/22/2025 
FR Recognition Number 2-312
Standard(Included in ASCA)
ASTM  F720-24
Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
Scope/Abstract
1.1 This test method is intended to determine the potential for a test article to elicit contact dermal allergenicity. This is a semi-quantitative method. There are no known limitations to this method.
1.2 The values stated in SI units, including units officially accepted for use with the SI, are to be regarded as standard. No other systems of measurement are included in this standard.
Extent of Recognition
Complete standard
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.
ASCA Notes
Used in conjunction with ISO 10993-10:2021 (recognition number 2-296).
Transition Period
FDA recognition of ASTM F720-17 [Rec# 2-256] will be superseded by recognition of ASTM F720-24 [Rec# 2-312]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-256] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 2-256] 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.

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
 Chandramallika (Molly) Ghosh
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  301-796-6496
  molly.ghosh@fda.hhs.gov
 Shelby Skoog
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  301-796-2800
  Shelby.Skoog@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Biocompatibility
*These are provided as examples and others may be applicable.
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