FDA exemptions can confuse even the most seasoned regulatory specialist, and it can be difficult to know which process controls apply to your device. Stay calm and GMP on, my friends, because help is on the way.
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 summary video, Michelle explains the FDA exemptions and requirements 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.
Looking for a deeper discussion of FDA exemptions and how they align with the device classification? Check this out.
And here’s more detail on choosing the right submission pathway for your device: https://leanraqa.com/choosing-the-right-fda-submission-pathway/
