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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 025 Date of Entry 10/04/2010 
FR Recognition Number 15-19
Standard
ASTM F2450-10 Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products
Scope/Abstract
1.1 This guide covers an overview of test methods that may be used to obtain information relating to the dimensions of pores, the pore distribution, the degree of porosity, interconnectivity, and measures of permeability for porous materials used as polymeric scaffolds in the development and manufacture of tissue-engineered medical products (TEMPs). This information is key to optimizing the structure for a particular application, developing robust manufacturing routes, and providing reliable quality control data.
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FDA recognition of ASTM F2450-10 [Rec# 15-19] will be superseded by recognition of ASTM F2450-18 [Rec# 15-59]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 15-19] until July 11, 2021. After this transition period, declarations of conformity to [Rec# 15-19] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
This standard is relevant for medical devices/combination products where tissue engineering is a component of the development and manufacture of the product
Relevant FDA Guidance and/or Supportive Publications*
Guidance Document for Testing Biodegradable Polymer Implant Devices 1996.

Guidance for Industry Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin, September 1998.

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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