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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 8-542
Standard
ASTM  F138-19
Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
Scope/Abstract
1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought 18chromium-14nickel-2.5molybdenum stainless steel bar and wire used for the manufacture of surgical implants.
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.
Public Law, CFR Citation(s) and Procode(s)*
Implantable Medical Devices
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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