| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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046
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Date of Entry 12/23/2016
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FR Recognition Number
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2-94
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| Standard | |
ASTM F981-04 (Reapproved 2016)
Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone |
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Scope/Abstract1.1 This practice provides a series of experimental protocols for biological assays of tissue reaction to nonabsorbable biomaterials for surgical implants. It assesses the effects of the material on animal tissue in which it is implanted. The experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, immune response, carcinogenicity, teratogenicity, or mutagenicity of the material since other standards deal with these issues. It applies only to materials with projected applications in humans where the materials will reside in bone or soft tissue in excess of 30 days and will remain unabsorbed. It is recommended that short-term assays, according to Practice F763, first be performed. Applications in other organ systems or tissues may be inappropriate and are therefore excluded. Control materials will consist of any one of the metal alloys in Specifications F67, F75, F90, F136, F138, or F562, high purity dense aluminum oxide as described in Specification F603, ultra high molecular weight polyethylene as stated in Specification F648 or USP polyethylene negative control.
1.2 This practice is a combination of Practice F361 and Practice F469. The purpose, basic procedure, and method of evaluation of each type of material are similar; therefore, they have been combined. |
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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| FDA recognition of ASTM F981-04 (Reapproved 2016) [Rec# 2-94] will be superseded by recognition of ASTM F981-23 [Rec# 2-302]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-94] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 2-94] will not be accepted. |
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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*
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. |
