| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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044
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Date of Entry 07/26/2016
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FR Recognition Number
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2-213
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| Standard | |
ASTM F1904-14
Standard Practice for Testing the Biological Responses to Particles In Vivo |
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Scope/Abstract1.1 This practice covers the production of wear particles and degradation products from implanted materials that may lead to a cascade of biological responses resulting in damage to adjacent and remote tissues. In order to ascertain the role of particles in stimulating such responses, the nature of the responses, and the consequences of the responses, established protocols are needed. This is an emerging, rapidly developing area and the information gained from standard protocols is necessary to interpret responses. Some of the procedures listed here may, on further testing, not prove to be predictive of clinical responses to particulate debris. However, only the use of standard protocols will establish which are useful techniques. Since there are many possible and established ways of determining responses, a single standard protocol is not stated. However, this recommended practice indicates which necessary information should be supplied with test results. For laboratories without established protocols, recommendations are given and indicated with an asterisk (*).
1.2 This standard is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material. |
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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| FDA recognition of ASTM F1904-14 [Rec# 2-213] will be superseded by recognition of ASTM F1904-23 [Rec# 2-299]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-213] until July 5, 2026. After this transition period, declarations of conformity to [Rec# 2-213] 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*
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 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. |
