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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 049 Date of Entry 06/07/2018 
FR Recognition Number 15-51
Standard
ASTM  F2347-15
Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
Scope/Abstract
1.1 This guide covers the evaluation of hyaluronan suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, Tissue Engineered Medical Products (TEMPs).
1.2 This guide addresses key parameters relevant to the characterization and purity of hyaluronan.
1.3 As with any material, some characteristics of hyaluronan may be altered by processing techniques, such as crosslinking and sterilization, required for the production of a specific formulation or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy and are not addressed in this guide.
Extent of Recognition
Complete standard
Rationale for Recognition
Standard is recognized on a scientific basis: Material characterization.
Public Law, CFR Citation(s) and Procode(s)*
This standard is relevant for medical devices where tissue engineering is a component of the development and manufacture of the product
Relevant FDA Guidance and/or Supportive Publications*
Final Guidance for FDA and Industry : The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles, Issued October 2002.

Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage, Issued December 2011.

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 Contact
 David Kaplan
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-2519
  david.kaplan@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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