Acme Medical, a manufacturer of novel medical devices, is developing a new device. The company is ready to start preparing documents to file with the FDA, but still needs to determine whether the device will be a Class II or Class III device. At product launch, the expiration dating will be short due to current stability data, but the company is planning to file a supplement in the future after they run a new stability study that will hopefully justify longer shelf life. Answer the questions below:

a$)$ What type of FDA Application $($if any$)$ is required for each of the two possible device classifications?

b$)$ What type of FDA Supplement $($if any$)$ will be required for each of the two possible device classifications if the stability data to support new expiration dating are submitted to the FDA along with the supplement?

c$)$ How can the company avoid an FDA Supplement to extend the expiration date if the device is Class III?