FDA Approval of Medical Modelling

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Does anyone have any information regarding any requirements
for United States Food and Drug Administration (FDA) approval
for 3D medical modelling? Do software programs such as
Materialize's MIMICS need to have FDA approval to be used in
a hospital? Do rapid prototyping systems such as
stereolithography also need such approval? Do any of these
systems already have approval?

Any information or assistance in this matter would be greatly
appreciated.

Col David A. Chance, USAF, DC
Office of the Assistant Secretary of Defense (Health Affairs)
DMIM/DDSS
dchance@ha.osd.mil
(703) 681-3969

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