As Dr. Simon discussed in his lecture videos, the clearance of a Class II device can at times be as costly and timely as a Class III device. Certain Class II devices will require a investigational device exemption (IDE) to support the safety and effectiveness in the 510(k) application. An IDE must be approved by the FDA to perform clinical trials on a medical device that poses a “significant risk”, i.e. a device that poses a serious risk to the health, safety, and welfare of a patient. Even if the device does not pose a “significant risk”, the IRB must approve an investigational plan before conducting clinical trials. Now, if the 510(k) application for the device is rejected and is therefore classified as Class III, a 510(k) resubmission or a de novo application can be submitted to reclassified the device as a Class II. If the FDA finally clears the device as Class II, the risks of a postmarket failure are higher than if the product was approved as a Class III product through a PMA. A postmarket failure will result in a product recall and cna result in total costs that could very well exceed the expenses of obtaining a PMA.