FDA Expedited Regulatory Submission Review of Device or Device with Drug Product

FDA from time to time, publishes nonbinding recommendations for device, technology, drug or otherwise, for expedited regulatory review in an effort to benefit patients who fall into a unmet medical emergent, urgent need for therapy, in need of new breakthrough technology and serves the best interest of patients in life-threatening situations or irreversible debilitating disease or condition.

Breakthrough technologies must be demonstrated to lead to a clinical improvement in the treatment or diagnosis of the life-threatening or irreversibility debilitating condition.

The device must provide for a clinically important earlier or more accurate diagnosis or offer important therapeutic advantages in safety and/or effectiveness over existing alternatives. For examples:

• superiority over current treatments for advantages on serious outcomes (e.g., morbidity)
• ability to provide clinical benefit for those patients unable to tolerate current treatment
• ability to provide a clinical benefit without the serious side effects associated with current treatments.

The availability of the device must be in the best interest for patients and that is, the device provides a specific public health benefit or meets the need of a well-defined patient population.

All provisions may also apply to a device that was designed or modified to address an unanticipated serious failure occurring in a critical component of an approved device for which there a no alternatives or for which alternative treatment would entail substantial risk of morbidity for the patient.

FDA is open to demonstrations of real benefit for the safety and well-being of patients who have compassionate and life-threatening pleas. Regulatory submission documentation and dossier for the device, device with drug must be pristine, demonstrate clinically meaningful and statistically significant benefit, quality-controlled data and provide a remarkable and superior benefit/risk statement.