Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

065

Date of Entry 12/22/2025

FR Recognition Number

8-634

Standard

ASTM F2066-23
Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)

Scope/Abstract

1.1 This specification covers the chemical, mechanical, and metallurgical requirements for wrought titanium-15 molybdenum alloy to be used in the manufacture of surgical implants (1).2

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FDA recognition of ASTM F2066-18 [Rec# 8-484] will be superseded by recognition of ASTM F2066-23 [Rec# 8-634]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-484] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 8-484] will not be accepted.

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