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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 044 Date of Entry 07/26/2016 
FR Recognition Number 2-122
Standard
ASTM F719-81 (Reapproved 2012)
Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
Scope/Abstract
1.1 This practice covers a procedure by which the irritancy of a biomaterial may be assessed through contact with abraded and intact skin of rabbits.

1.2 The results of this practice depend upon the effectiveness with which contact between the skin and the test material is established and maintained. Because of the operator technique included in performing this test, it is important that the test be performed by personnel with appropriate training.
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.
Transition Period
FDA recognition of ASTM F719-81 (Reapproved 2012) [Rec# 2-122] will be superseded by recognition of ASTM F719-20 e1 [Rec# 2-278]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-122] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 2-122] 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*
ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.

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 on June 16, 2016.



Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
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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