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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 051 Date of Entry 01/14/2019 
FR Recognition Number 15-56
Standard
ASTM  F3224-17
Standard Test Method for Evaluating Growth of Engineered Cartilage Tissue using Magnetic Resonance Imaging
Scope/Abstract
1.1 This standard is intended as a standard test method for engineered cartilage tissue growth evaluation using MRI.

1.2 This standard is intended for use in the development of tissue engineering regenerative medical products for cartilage damages, such as in knee, hip, or shoulder joints.

1.3 This standard has been prepared for evaluation of engineered cartilage tissue growth at the preclinical stage and summarizes results from tissue growth evaluation of tissue-engineered cartilage in a few notable cases using water spin-spin relaxation time, T2, in vitro and in vivo in small animal models.

1.4 This standard uses the change in mean T2 values as a function of growth time to evaluate the tissue growth of engineered cartilage.

1.5 This standard provides a method to remove the scaffold contribution to the tissue growth evaluation.

1.6 Information in this standard is intended to be applicable to most porous natural and synthetic polymers used as a scaffold in engineered cartilage, such as alginate, agarose, collagen, chitosan, and poly-lactic-co-glycolic acid (PLGA). However, some materials (both synthetic and natural) may require unique or varied methods of MRI evaluation that are not covered in this test method.
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.
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 Kaplan
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-2519
  david.kaplan@fda.hhs.gov
 Sunder Rajan
  FDA/OC/CDRH/OSEL/DBP/
  301-796-4194
  sunder.rajan@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Tissue Engineering
*These are provided as examples and others may be applicable.
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