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.
