Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

036

Date of Entry 07/09/2014 

FR Recognition Number

8-377

Standard

ASTM  F136-13
Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)

Scope/Abstract

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought annealed titanium-6aluminum-4vanadium ELI (extra low interstitial) alloy (R56401) to be used in 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

Terry O. Woods   FDA/OC/CDRH/OSPTI/ORR/DSCA   301-796-2503   terry.woods@fda.hhs.gov

David M. Saylor   FDA/OC/CDRH/OSEL/DBCMS/   301-796-2626   david.saylor@fda.hhs.gov

Michael J. Ryan   FDA/OC/CDRH/OPEQ/ORP/   301-796-6283   michael.ryan@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.