Clean enough for my mouth?

[sdk_imported]

I am new to injection molded medical devices. I am designing a plastic part that will go inside a person's mouth.

The part must satisfy the ISO 10993 biocompatibility standards (cytotoxity, sensitization, and irritation). I would like to start by doing some prototype molding for clinical testing.

Here are my question:

(1) If I mold prototpyes in a clean (not "clean room") environment and then follow a simple cleaning protocol, will the device satisfy this biocompatibility requirements per ISO 10993?

(2) Is it really necessary to have a lab run biocompatibility testing on the parts before using them on people? The test takes roughly 2 months at a cost of about $10k.

I would appreciate any feedback from an injection molder of finished products that are FDA class 1 medical devices.

Thanks in adavance.

 

[dwightdixon]

Things you stick in your mouth are not as closely controlled as thing you stick in your viens. You do need to have a professional FDA compliance consultant on your staff to make sure you do not get into legal trouble but you do not need a class 100 room for a mouth guard. There are independent labs who could do the screening tests for less than $2,000. You should use FDA approvable materials from reliable sources which will furnish you their Drug materfile numbers for you to use in your filing with the FDA if there is one required. They also may be able to direct you to a reasonably priced FDA consultant.