| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
059
|
Date of Entry 12/19/2022
|
|
FR Recognition Number
|
2-297
|
| Standard | |
ASTM F763-22
Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials |
|
Scope/Abstract1.1 This practice provides guidelines for short-term testing or screening of candidate materials, both porous and dense, as to the local effects of the material that is implanted intramuscularly. This method may not be applicable for absorbable materials, depending on the absorption profile of the test material. The tissue reactions will be evaluated in comparison to those evoked by control materials that are accepted as clinical implant materials. This is a short-term (less than 30 days) screening procedure for determining acceptability of candidate materials.
1.2 This practice, along with other appropriate biological tests (including other appropriate ASTM tests), may be used in the biocompatibility assessment of the candidate materials for use in the fabrication of devices for clinical application.
1.3 This experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity, or mutagenicity of the material since other standards address these issues.
1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 provides guidance for the selection of appropriate methods for testing materials for a specific application. |
|
| 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| FDA recognition of ASTM F763-04 (Reapproved 2016) [Rec# 2-93] will be superseded by recognition of ASTM F763-22 [Rec# 2-297]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-93] until December 22, 2024. After this transition period, declarations of conformity to [Rec# 2-93] will not be accepted. |
|
Public Law, CFR Citation(s) and Procode(s)*
| 21 CFR 58 Good Laboratory Practise for Nonclinical Laboratory Studies |
|
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. |
|
| FDA Technical Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
