| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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064
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Date of Entry 05/26/2025
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FR Recognition Number
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2-305
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| Standard | |
ASTM E1262-24
Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay |
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Scope/Abstract1.1 This guide highlights some of the more relevant biological concepts as they are currently understood, and summarizes the critical technical aspects for acceptable bioassay performances as they currently are perceived and practiced. The Chinese hamster ovary cell/hypoxanthine guanine phosphoribosyl transferase (CHO/HGPRT) assay has been widely applied to the toxicological evaluation of industrial and environmental chemicals. The method is limited to detection of small-scale genetic interactions. Therefore, when this method is used for genotoxicity assessment it is recommended that an in vitro clastogenicity assay (for example, chromosomal aberration, micronucleus) is considered to detect large-scale (for example, chromosomal) DNA damage.
1.2 This guide concentrates on the practical aspects of cell culture, mutagenesis procedures, data analysis, quality control, and testing strategy. The suggested approach represents a consensus of the panel members for the performance of the assay. It is to be understood, however, that these are merely general guidelines and are not to be followed without the use of sound scientific judgement. Users of the assay should evaluate their approach based on the properties of the substances to be tested and the questions to be answered.
1.3 Deviation from the guidelines based on sound scientific judgement should by no means invalidate the results obtained.
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| Extent of Recognition
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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. |
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Transition Period
| FDA recognition of ASTM E1262-88 (Reapproved 2018) [Rec# 2-136] will be superseded by recognition of ASTM E1262-24 [Rec# 2-305]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-136] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 2-136] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| 21 CFR 58 Good Laboratory Practices for Nonclinical Laboratory Studies |
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Relevant FDA Guidance and/or Supportive Publications*
1. ISO 10993-12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.
2. 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. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
