NinjaFlex vs. FilaFlex - Any opinions?

[ralphzoontjens]

TPUs can be FDA approved, but I haven't seen any filaments so far with the approval. Would be interesting to know.

[American 3D Printing]

TPUs can be FDA approved, but I haven't seen any filaments so far with the approval. Would be interesting to know.

There is no such thing as FDA "approval" for a material per se', however medical devices can be cleared for marketing through the 510(k) process for class II devices and with clinical trials for class III devices. When FDA reviews a device for marketing, materials of manufacture are among the characteristics that are evaluated by the FDA reviewer. In the case of pharmaceuticals, both the formulary and the manufacturing process are evaluated, including materials that may come in contact with the pharmaceutical during manufacture and packaging.

There is however a list FDA-approved of materials called "GRAS" which stands for "Generally Regarded As Safe". These are for food ingredients and additives rather than materials such as TPU.