United Health Products to proceed with final drafting of PMA documentation

United Health Products reports on the receipt and review of final reports on product sterilization and stability testing for its hemostatic gauze. As previously disclosed, UHP has been working with external packaging and sterilization service providers to complete various required tests for its Premarket Approval application. The reported data received this week on the efficacy of the proposed radiation sterilization protocol were well within acceptable bioburden levels for Class III products. UHP will now compile these data and proceed with final drafting of the PMA documentation to be submitted via the eSTAR platform for FDA and Health Canada review.