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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 046 Date of Entry 12/23/2016 
FR Recognition Number 8-443
Standard
ASTM F3160-16
Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants
Scope/Abstract
1.1 This guidance document provides metallurgical characterization information that may be beneficial in the evaluation of absorbable metallic materials intended for medical implant applications. This guide is primarily intended for absorbable metallic materials that undergo further processing into a fabricated final device. Therefore, this standard does not require assessments that are more appropriately conducted on the final device, such as biological evaluation. However, a few relevant standards for finished implant devices are included for information purposes.

1.2 The purpose of this guide is to identify appropriate test methods and relevant medical product standards that can be used to develop future standards for new or modified absorbable metallic materials.

1.3 This guide is not intended to cover other major classes of absorbable materials such as polymers, ceramics, composites, and tissue-engineered materials.

1.4 This standard guide is focused on the chemical, physical, microstructural, and mechanical properties plus inspection guidelines for metallic materials that are used for medical implants designed to be absorbed in the body over a period of time. This guide focuses on material characterizations and does not address device specific mechanical testing that may be necessary to determine safety and functionality of the implant.

1.5 Compliance with materials specifications developed in accordance with this standard may not necessarily result in a material suitable for its intended purpose. Additional testing specific to the intended use may be required.

1.6 Since surface modifications of medical implants are generally applied in the latter stages of manufacturing, this standard guide does not cover the characterization of either absorbable or non-absorbable surface coatings that are metallic in origin such as oxides or from the addition of other materials such as ceramics or polymers. However, this standard does apply to absorbable metallic materials, regardless of the presence or absence of a coating.
Extent of Recognition
Complete standard
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 F3160-16 [Rec# 8-443] will be superseded by recognition of ASTM F3160-21 [Rec# 8-575]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-443] until December 18th, 2022. After this transition period, declarations of conformity to [Rec# 8-443] will not be accepted.
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.
FDA Technical Contacts
 David M. Saylor
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-2626
  david.saylor@fda.hhs.gov
 Matthew Di Prima
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2507
  matthew.diprima@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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