This is not a drug, but medical device technology. Therefore, I believe this would qualify for the FDA's pre-market Breakthrough Device Program[1] clearance whi

This is not a drug, but medical device technology. Therefore, I believe this would qualify for the FDA's pre-market Breakthrough Device Program[1] clearance which, if I'm reading the guidelines correctly, says they can have an expedited decision within 45-60 days from submission[2]. This is under the umbrella of the FDA's Medical Device Safety Action Plan[3] overhaul. [1] https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program https://www.fda.gov/medical-devices/how-study-and-market-you... [2] https://www.fda.gov/media/108135/download https://www.fda.gov/media/108135/download [3] https://www.fda.gov/about-fda/cdrh-reports/medical-device-safety-action-plan-protecting-patients-promoting-public-health https://www.fda.gov/about-fda/cdrh-reports/medical-device-sa...