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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 2-133
Standard
ASTM F1408-97 (Reapproved 2013)
Standard Practice for Subcutaneous Screening Test for Implant Materials
Scope/Abstract
1.1 This practice covers a short-term testing method to screen the subcutaneous tissue reaction to metallic or other implant candidate materials in small laboratory animals. The material may be dense or porous. The tissue reactions will be evaluated in comparison to those evoked by control materials that are accepted as clinical implant materials.

1.2 This practice, along with other appropriate biological tests (including other ASTM test methods), may be used to assess the biocompatibility of candidate materials for use in the fabrication of devices for clinical application. It may be also applied to evaluate the effect of special surface textures and preparations of known materials.

1.3 This experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material.
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FDA recognition of ASTM F1408-97 (Reapproved 2013) [Rec# 2-133] will be superseded by recognition of ASTM F1408-20a [Rec# 2-280]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-133] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 2-133] will not be accepted.


Public Law, CFR Citation(s) and Procode(s)*
21 CFR 58 Good Laboratory Practices 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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