CytoSorbents Corporation (CTSO)

[Paulness]

FDA proposes new expedited access program for medical devices.This may be very important for CTSO. Google FDA news. FDA proposes new expedited access program for medical devices that address unmet medical needs. To be eligible for participation in the program, the medical device must:
• Be intended to treat or diagnose a life-threatening or irreversibly-debilitating disease or condition
• Represent one of the following:
1. no approved alternative treatment/diagnostic exists, or
2. a breakthrough technology that provides a clinically meaningful advantage over existing technology, or
3. offers a significant, clinically meaningful advantage over existing approved alternatives, or
4. availability is in the patient’s best interest
• Have an acceptable data development plan that has been approved by the FDA