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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Entry 07/09/2014 
FR Recognition Number 15-39
Standard
ASTM F2150-13 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissued-Engineered Medical Products
Scope/Abstract
1.1 This guide is a resource of currently available test methods for the characterization of the compositional and structural aspects of biomaterial scaffolds used to develop and manufacture tissue-engineered medical products (TEMPs).

1.2 The test methods contained herein guide characterization of the bulk physical, chemical, mechanical, and surface properties of a scaffold construct. Such properties may be important for the success of a TEMP, especially if they affect cell retention, activity and organization, the delivery of bioactive agents, or the biocompatibility and bioactivity within the final product.

1.3 This guide may be used in the selection of appropriate test methods for the generation of an original equipment manufacture (OEM) specification. This guide also may be used to characterize the scaffold component of a finished medical product.

1.4 This guide is intended to be utilized in conjunction with appropriate characterization(s) and evaluation(s) of any raw or starting material(s) utilized in the fabrication of the scaffold, such as described in Guide F2027.

1.5 This guide addresses natural, synthetic, or combination scaffold materials with or without bioactive agents or biological activity. This guide does not address the characterization or release profiles of any biomolecules, cells, drugs, or bioactive agents that are used in combination with the scaffold. A determination of the suitability of a particular starting material and/or finished scaffold structure to a specific cell type and/or tissue engineering application is essential, but will require additional in vitro and/or in vivo evaluations considered to be outside the scope of this guide.
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FDA recognition of ASTM F2150-13 [Rec# 15-39] will be superseded by recognition of ASTM F2150-19 [Rec# 15-61]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 15-39] until July 11, 2021. After this transition period, declarations of conformity to [Rec# 15-39] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Medical Devices Containing Materials Derived from Animal Sources (Except In Vitro Diagnostic Devices), Issued March 2019.

Guidance for Industry and FDA Staff: The Least Burdensome Provisions: Concept and Principles, Issued February 2019.

Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage, Issued December 2011 (CBER and CDRH).

Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh, Issued March 1999.

Guidance for Industry: Guidance Document for Dura Substitute Devices, Issued 2000.

Guidance for Industry and FDA Staff: Surgical Sutures - Class II Special Controls, Issued June 2003.
FDA Technical Contacts
 David Kaplan
  FDA/OC/CDRH/OSEL/DBCMS/
  301-796-2519
  david.kaplan@fda.hhs.gov
 Rakhi Dalal
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-6418
  rakhi.dalal@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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