What happens if the device fails the NTEP evaluation?
If the device fails to meet the requirements of the NTEP evaluation, the applicant will receive a written deficiency report from the laboratory stating the applicable regulations that the device failed to meet along with information supporting this conclusion. The applicant will have 90 days from the receipt of the deficiency report to correct the deficiencies and resubmit the device to the laboratory. If the device fails three evaluations, it will then enter the excessive failure process. The applicant will be notified by NCWM and will have 90 days to submit proof of corrective action to NCWM. If corrective action is considered acceptable, one final evaluation will be conducted. If corrective action is deemed to be insufficient, or if the device fails to meet all requirements during this fourth evaluation, the project will be closed.
