PPT Slide

FDA InterCenter

Tissue Engineering

Working Group (WG)



FDA Natural

Materials

WG



Reviewers



ASTM TEMPS Standards



Development of Standards

and Test Methods



Product

Review



Tissue Engineered Medical Products Standards (TEMPS)



Researchers



Materials and Cells



Standard

Recognition by

CDRH



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Notes:

Interaction between researchers & reviewers
TEWG interfaces regulatory concerns of FDA reviewers with the technical expertise of researchers to develop test methods
Natural Materials WG, subcommittee of TEWG, and covers development of standards & test methods related to natural materials such as alginate, chitosan and collagen.
NMWG identifies problems in the evaluation of submissions due to lack of characterization of these natural materials.
Newly-developing standards & test methods are aimed at Materials characterization, Cell characterization and the Interaction between Cells & Materials.
Standards developed under auspices of ASTM, F04, Div IV, TEMPS.
Composed of members from industry academia and government.
Once standards developed, they have to be formally recognized by CDRH and can then be used in Product Review by the Reviewers.