MakerGear Forum

Is anyone aware of a filament which has FDA certification BEYOND that needed for food contact?? With the increasing volume of 3D printers being produced, it's only a matter of time until there is interest in applications in medicine and dentistry. Accuracy and strength of printed parts would need validation, but that is relatively straight-forward. Currently, clinicians are stuck with using service houses which charge astronomical prices for the rapid prototyping. StrataSys has one material which has met the basic ISO regulation for tissue contact, but nothing with the FDA. PLA would seem to be a natural as it's been used for resorbable bone plates, screws and suture material for over 40 years. It would be fantastic if someone would take the time to get certification of PLA other than for food containers or food contact.
Many Thanks!
Paul T

Even if the filament is good, you still have to certify the machines themselves. This means all lubricants must be food (or medical!) grade, and everything must be RoHS-compliant. I believe this means the brass nozzles are out, since they could contain traces of lead.