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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 053 Date of Entry 12/23/2019 
FR Recognition Number 8-491
Standard
ASTM  F1088-18
Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
Scope/Abstract
1.1 This specification covers chemical and crystallographic requirements for beta-tricalcium phosphate (beta-TCP) for surgical implant applications. For a material to be identified as medical-grade beta-tricalcium phosphate, it must conform to this specification (see Appendix X1).
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)*
Regulation Number Device Name Device Class Product Code
§888.3045 Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) Class 2 MBP
§888.3045 Filler, Bone Void, Calcium Compound Class 2 MQV
§888.3045 Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation Class 2 OIS
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
 Peter Allen
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-6402
  peter.allen@fda.hhs.gov
 Limin Sun
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-7056
  limin.sun@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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