Hacker News Reader

Their projection dates seem a little far fetched, to have a clinical trial by 2020 without yet having started an FDA process

View on HN

Far fetched is an under-statement. It's not possible unless they're planning to do human trials of some non-invasive technology related to the larger product.

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-you...

[2] https://www.fda.gov/media/108135/download

[3] https://www.fda.gov/about-fda/cdrh-reports/medical-device-sa...

Reply on news.ycombinator.com