When to request a Breakthrough Devices DesignationYou can send a...

When to request a Breakthrough Devices Designation

You can send a Breakthrough Designation request for your device at any time prior to sending your marketing submission (for example, premarket approval (PMA), premarket notification (510(k)), or De Novo classification request).

Answer within 60 days from FDA

https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program

This is really amazing news that means Breakthrough Device Status is also now commercially meaningful, with immediate Medicare reimbursement available via CMS MCIT pathway.

@Hotdog11, you may find this information useful for your bio investment. Prior approvals for FDA for Breakthrough Device status can be back dated to 2019 for the Medicare reimbursement & effective immediately on approval from CMS!