| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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052
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Date of Entry 07/15/2019
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FR Recognition Number
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2-265
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| Standard | |
ASTM F2901-19
Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices |
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Scope/Abstract1.1 Medical devices may cause adverse effects on the structure and/or function of the nervous system. In this guide, these adverse effects are defined as neurotoxicity. This guide provides background information and recommendations on methods for neurotoxicity testing. This guide should be used with Practice F748, and may be helpful where neurotoxicity testing is needed to evaluate medical devices that contact central and/or peripheral nervous system tissue or cerebral spinal fluid (CSF).
Note 1: The results of these in vitro and in vivo tests may not correspond to actual human response.
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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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Public Law, CFR Citation(s) and Procode(s)*
| 21 CFR 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.
Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers, Issued June 2012.
ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials.
ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity.
ISO 10993-6:2016 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation.
ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.
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. |
