Regulatory strategy got you down? Aching head from trying to understand what process controls apply to your device? FDA submission requirements are not always easy to understand, and misinterpreting the requirements can be disastrous for your project. Do you need to perform a clinical trial for your device? Or is your Class III device exempt from the 510K requirement? If your device is exempt from the 510K requirement, do you still need a PMA? How do you determine what process controls apply to your device? In this video, Michelle Lott, RAC explains the requirements and exemptions that apply to each class of device and outlines the process controls that need to be part of your development, manufacturing and FDA submission plans.