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

Michael J. Ryan

FDA/OC/CDRH/OPEQ/ORP/

301-796-6283

michael.ryan@fda.hhs.gov

Terry O. Woods

FDA/OC/CDRH/OSEL/DAM/

301-796-2503

terry.woods@fda.hhs.gov

David M. Saylor

FDA/OC/CDRH/OSEL/DBCMS/

301-796-2626