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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Recognition 07/15/2019 
FR Recognition Number 15-58
Standard
ASTM F2103-18
Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
Scope/Abstract
1.1 This guide covers the evaluation of chitosan salts 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 for the functionality, characterization, and purity of chitosan salts.

1.3 As with any material, some characteristics of chitosan may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy.

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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FDA recognition of ASTM 2103-11 [Rec# 15-28] will be superseded by recognition of ASTM F2103-18 [Rec# 15-57]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 15-28] until July 26, 2020. After this transition period, declarations of conformity to [Rec# 15-28] 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
There is no relevant guidance developed at this time.
FDA Technical Contact
 David Kaplan
  FDA/OMPT/CDRH/OSEL/DAM/
  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
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