United Health Products Inc (UEEC)

[DR5]

I disagree, this is a fast track approval process. I copied this from the press release that the FDA selected UEEC as one of 9 companies for the CTQ Pilot program. Read the excerpt below:

“The FDA has stated that it intends to work collaboratively with pilot program participants during the review of their PMA submission to define characteristics of the device that are critical to product quality, and how these characteristics are controlled in design and manufacturing prior to the post market inspection. For pilot program participants, the FDA would forego conducting the standard PMA preapproval inspection, and a post market inspection focusing on the PMA applicant’s implementation of the critical to quality characteristics would be conducted instead.”

So, the FDA has been “working collaboratively” with the company so that when they accepted the application in October; the FDA’s acceptance indicated an agreement to the substance of the submission. That acceptance streamlines the approval process and makes this kind of approval much quicker than a standard submission which generally takes (as you said) 5-10 months. IMO