When will I find out if my device received Breakthrough Device...

When will I find out if my device received Breakthrough Device Designation

The FDA intends to request any other information needed to inform the Breakthrough Device designation decision within 30 days of receiving your request. You can expect to receive a letter communicating the FDA's decision to grant or deny the Breakthrough Device designation request within 60 calendar days of the FDA receiving your request.

It is helpful when a sponsor is available and responsive to the FDA's requests throughout the review timeline. If the FDA does not receive the other information needed to decide on a designation request promptly, it may result in denial of the Breakthrough Device designation request.

60 calendar days! could be longer since it's a de novo device

I was sitting here today thinking about the designation result and how big of an announcement it is. At that point the business is largely derisked and going at breakneck speed to satisfy the clinical trial requirements with close aid from the FDA!

If the FDA say 'APPROVED' and offer to hold EMV's hand through the clinical trials, it isn't too big of a statement to say that this company hurdle is arguably bigger than the successful completion of the clinical trials. Tick this box and it makes that one look much more like a formality!

The fact that the FDA recommended the designation means they have already been exposed to the project and believe in the enormous effect it can have on mainstream society. Which government wouldn't want to rid themselves of a large percentage of stroke related carnage expense?!

best case seems 1.5-2 months...