| 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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2-306
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| Standard | |
ASTM F1439-24
Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials |
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Scope/Abstract1.1 This guide is intended to assist the testing laboratory in the conduct and evaluation of tumorigenicity tests to evaluate the potential for materials to evoke a neoplastic response.
1.2 Carcinogenicity, which includes tumorigenic potential, is one of several biological effects that should be considered when evaluating the biological response to a material or a final, finished medical device as recommended in Practice F748. It is assumed that the evaluator has already determined that this type of testing is necessary for a particular material or medical device before consulting this guide. The recommendations of Practice F748 should be considered before a study is commenced.
1.3 Whenever possible, it is recommended that a battery of genotoxicity tests be proposed and initiated as an alternative to an in vivo tumorigenicity bioassay. Chemical information and data from the literature regarding non-genotoxic carcinogens, if present, may also be considered when evaluating the carcinogenic potential. Genotoxicity assays may also be considered as initial screening procedures due to the sensitivity of the assays, the significant reduction in time to gain valuable data, and the desire to reduce the use of animals for testing. Genotoxicity assays that may be considered are outlined in Guide E1262 and in OECD 471, OECD 487, and OECD 490. The investigator is advised to carefully consider the appropriateness of a particular method for application after a review of the published literature.
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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 F1439-03 (Reapproved 2018) [Rec# 2-145] will be superseded by recognition of ASTM F1439-24 [Rec# 2-306]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-145] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 2-145] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies |
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Relevant FDA Guidance and/or Supportive Publications*
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. |
