| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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052
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Date of Entry 07/15/2019
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FR Recognition Number
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8-504
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| Standard | |
ASTM F561-19
Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids |
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Scope/Abstract1.1 This practice covers recommendations for the retrieval, handling, and analysis of implanted medical devices and associated specimens that are removed from human and animal subjects during revision surgery and at postmortem. This practice may be used for the analysis of any implant including inert, bioactive, resorbable, and tissue engineered products. This practice can also be used for analysis of specimens and fluids from in vitro tests, including those from wear tests and joint simulators. The aim is to provide guidance to minimize iatrogenic damage during the recovery and handling of the associated specimens which could obscure the investigational results. This practice is also intended to provide guidance as to gathering data at the proper time and circumstance.
1.2 This practice offers guidelines for the analysis of retrieved implants to limit damage to them, and to allow comparisons between investigational results from different studies. The protocols are divided into three stages, where Stage I is the minimum non-destructive analysis, Stage II is more complete non-destructive analysis, and Stage III is destructive analysis. Standard protocols for the examination and collection of data are provided for specific types of materials in relation to their typical applications. For particular investigational programs, additional, more specific, protocols may be required. If special analytical techniques are employed, the appropriate handling procedures must be specified. Note that regulations for handling of patient information, tissues, and retrieved devices will vary by geography.
1.3 This practice should be applied in accordance with pertinent regulations or legal requirements regarding the handling of patient data as well as the handling and analysis of retrieved implants and excised tissues, especially with regard to handling devices which may become involved in litigation, as in accordance with Practice E860. Note that regulations for handling of patient information, tissues, and retrieved devices will vary by geography
1.4 A significant portion of the information associated with a retrieved implant device is often at the device-tissue interface or in the tissues associated with the implant and related organ systems. Attention should be given to the handling of adjacent tissues, so as not to interfere with study of the particles in the adjacent tissue, a chemical analysis for the byproducts of degradation of the implant, or a study of the cellular response to the implant.
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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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Public Law, CFR Citation(s) and Procode(s)*
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Relevant FDA Guidance and/or Supportive Publications*
| 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. |
