We are in the medical device market and more importantly with a...

We are in the medical device market and more importantly with a FDA breakthrough device status.

The following criteria must be met for FDA breakthrough device participation in the program:

• Device provides more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition
• Device represents breakthrough technologies
• No approved or cleared alternative device is currently marketed in the US
• Device offers significant advantages over existing approved or cleared alternatives
• Device availability is in the best interest of patients

If your device meets the above criteria, using the breakthrough program offers several advantages to speed up market availability and patient access. Some of the perks of this new program include

• Interactive and timely communication with FDA
• Pre/postmarket balance of data collection
• Efficient and flexible clinical study design
• Review team support
• Senior management engagement
• Priority review

Qualifying devices will undergo priority review, moving to the front of the queue and receiving additional review resources, according to the guidance. Some exciting program features include “sprint” discussions with FDA on novel issues related to the device, with the goal of reaching mutual agreement with the agency within a set time period. They provide a faster mechanism for communication with FDA compared to Pre-Sub meetings, allowing device development to move forward in a timely manner. FDA says that sprint discussions should focus on a single topic and follow a defined schedule.
If management executes well then finish line is many years closer than any other cancer drug company which people are speculating about.