Generex Biotechnology Corp. (fka GNBTQ)

[WeeZuhl]

You are welcome.

Getting 510K clearance is not trivial, and it does mean that the FDA agrees that the product is fit for it's intended use.

At a minimum, I appreciate someone who understands there is a difference between Drug Approval and Device Clearance, but more DD is required.





https://apnews.com/040fd5859f5c4800abaa9bb5c902e465

FDA’s ‘flawed’ device pathway persists with industry backing
By MATTHEW PERRONENovember 27, 2018

WASHINGTON (AP) — Roughly 3,000 medical devices enter the U.S. market every year through a system that generally requires little or no patient testing to verify safety and effectiveness.

Unlike new pharmaceuticals, most medical devices reviewed by the Food and Drug Administration are cleared based on similarities to already-approved devices, not specific clinical trial testing.

The agency’s streamlined review system has been blamed for a string of defective devices coming to market, including hip replacements that can leach metal debris into patients’ joints and pelvic mesh that can puncture internal organs. Still, the 42-year-old system persists, in part because of the power of the medical device lobby, which floods Washington with hundreds of lobbyists and millions of dollars.