Spectral Medical Inc T.EDT

RE:FDA Breakthrough Designation

[mercedesman]

Accountprince wrote: Did a little looking at the FDA website and the process takes about 60 calendar days from submission for the FDA to respond.  The AGM presentation was on June 20, 2022 but I expect was assembled the prior business day (or earlier) of June 17, 2022.  Let's use that date for FDA submission.

With a 60 calendar day timeframe for FDA response, they should hear back by August 16 2022 from the FDA.  So it would appear the non-disclosed time frame should be around mid-August to hear if the FDA has approved the breakthrough designation.

Here's a link

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



Is my device eligible?

Devices subject to premarket approval applications (PMAs), premarket notification (510(k)) or requests for De Novo designation are eligible for breakthrough device designation if both of the following criteria are met:

Criteria	Description	Refer to Guidance
First Criterion	The device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions	Section III.B.1
Second Criterion	The device also meets at least one of the following:
	Represents Breakthrough Technology	Section III.B.2.a
	No Approved or Cleared Alternatives Exist	Section III.B.2.b
	Offers Significant Advantages over Existing Approved or Cleared Alternatives	Section III.B.2.c
	Device Availability is in the Best Interest of Patients	Section III.B.2.d

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.