Clinic waived testing and procedure/IFU
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If (big if) the clinic lab is following the waived IFU exactly and there are no facility specific changes needed, what is the best way to have the medical director signature on the procedure ie IFU? For nonwaived it's pretty easy to obtain an editable version of the IFU from the manufacturer. I'm having a hard time finding that with the waived test kits. Instead of manually re-writing the IFU and adding signature, can a policy be created stating that for test XYZ the manufacturer IFU is to be followed and have med director signature that?
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If they are using the IFU as written, are you still putting the IFU into a Word/pdf document? Or do you have a statement on the sign off page stating the IFU is being used as written and include the actual IFU in the procedure pages?