| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
044
|
Date of Entry 07/26/2016
|
|
FR Recognition Number
|
2-227
|
| Standard | |
ASTM F1983-14
Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications |
|
Scope/Abstract1.1 This 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.
1.2 The time period for implant absorption will vary depending on chemical composition implant , implant location, and test subject species; therefore, the implantation times for examination of tissue response will be linked to the rate of absorption. No single implantation time is indicated in this practice.
1.3 These protocols assess the effects of the material on the animal tissue in which it is implanted. The experimental protocols do not fully assess systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material. Other standards are available to address these issues.
1.4 To maximize use of the animals in the study protocol, all toxicological findings should be recorded. There are some aspects of systemic toxicity, including effects of degradation products on the target organs, that can be addressed with this practice, and these effects should be documented fully. |
|
| Extent of Recognition
|
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. |
|
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| FDA recognition of ASTM F1983-14 [Rec# 2-227] will be superseded by recognition of ASTM F1983-23 [Rec# 2-301].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. |
|
Public Law, CFR Citation(s) and Procode(s)*
| 21 CFR Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies |
|
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. |
|
| FDA Technical Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
