| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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060
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Date of Entry 05/29/2023
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FR Recognition Number
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2-301
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| Standard | |
ASTM F1983-23
Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications |
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Scope/AbstractThis practice provides experimental protocols for biological assays of tissue reactions to absorbable biomaterials for implant applications. This practice applies only to absorbable materials with projected clinical applications in which the materials will reside in bone or soft tissue longer than 30 days and less than three years. Other standards with designated implantation times are available to address shorter time periods. Careful consideration should be given to the appropriateness of this practice for slowly degrading materials that will remain for longer than three years. It is anticipated that the tissue response to degrading biomaterials will be different from the response to nonabsorbable materials. In many cases, a chronic inflammatory response may be observed during the
degradation phase, but the local histology should return to normal after absorption; therefore, the minimal tissue response usually equated with biocompatibility may require long implantations.
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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| FDA recognition of ASTM F1983-14 [Rec# 2-227] will be superseded by recognition of ASTM F1983-23 [Rec# 2-301]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-227] until July 5, 2026. After this transition period, declarations of conformity to [Rec# 2-227] 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.
Guidance for Industry and Food and Drug Administration Staff: General Considerations for Animal Studies Intended to Evaluate Medical Devices, Issued March 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. |
