Tom Harkin actually said...

I don't care how small they are, they'd better meet the most stringent standards of safety and efficacy.

We should give them the resources. We've asked them to do a myriad of things, and yet we don't give them the resources to carry it out.

If a device manufacturer commits fraud on the FDA, puts a device out there, and injures people--but, they cannot sue and can't get discovery...

So, it doesn't go right back and go through the whole process again.