Replies to post #22644 on Lifeline Biotechnologies Inc (LLBO)

[yaro1]

Wow its the best and detailed article i think i have ever read!!!

[intexp]

I read tests are over and ITBRA works

[kilerb]

So it's already FDA approved… Class 2. Just not over the counter sales? That means hospitals can start using them?

[Domains]

I have a doubt according to the latest CISCO interview. For the first time we know that Cyrcadia is not presenting a Class II but a Class I FDA request. This is new and changes many things regarding what we believed until now. According to FDA documentation, 95% of Class I devices do not require FDA approval. We do not know if iTbra is part of the 5%. We also don't know why the previous Class II process has been now changed by a Class I.

Class I - These devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages. 47% of medical devices fail under this category and 95% of these are exempt from the regulatory process.

If a device falls into a generic category of exempted Class I devices, the premarket notification application and FDA clearance is not required before marketing the device in the U.S.

https://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ucm142523.htm

If this is so, we may be waiting for an FDA approval that never comes because is not what is being requested now. In the interview they talk that they already have the Class II approval and are not requesting a new one, but instead a Class I "clearance" which is not required according to the FDA rules.

The clinical trial has no influence on the Class I application, but would only serve to confirm that the digital version have slightly lower error rates. That is, it has beneficial effects for its commercialization but no effects at all for the FDA Class I process. The sales in the US can be started at any time when they have completed the administrative procedures of the Class I. No approval is required according to the FDA info. We may not hear anything this year or ever about an FDA approval.

The question is whether the FDA has already classified them as a Class I. If the iTbra doesn't fall into this category we may be facing a new delay, because a new 510(k) will be required, which will also need a completed clinical trial with all the required participants.

My concern is whether the change in strategy has not been due to a clinical trial that has proved valid but has not had the minimum number of participants required for a Class II 510 (k) application.

Can someone clarify this with objective information.
This detail can change many things.