Replies to post #26832 on Creative Medical Technology Holdings Inc (CELZ)

[NSX]

"FDA Approved is being misinterpreted here: Here is the fact!

The machine is FDA approved. The Kits are similarly FDA approved. The procedure is exempt from compliance with any additional FDA rules under CFR (Code of Federal Regulations):

Title 21 FDA chapter I, Subchapter L--Regulations under certain other acts administered by the FDA

Part 1271--Human cells, Tissues, and Cellular and tissue-based products
Sec. 1271015 are there any exceptions from the requirements of this part?

(b) "you are not required to comply with the requirements of this part if you are an establishment that removes HCT/P's from an individual and implants such HCT/P's into the same individual during the same surgical procedure."