United Health Products Reports on FDA Application Status
MESQUITE, NV, Oct. 03, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire - United Health Products, Inc. (OTCPK: UEEC) today provided an update on the company’s FDA Premarket Approval application process.
The company reports today that the packaging testing process is substantially completed with no non-conforming results. Testing completed to date includes assessment of labeling durability, Tyvek pouch packaging integrity, product stability under transport-related agitation, product stability under 6-month and 1-year accelerated aging treatment. The company is awaiting final reports on sterilization and bio burden testing.
In anticipation of re-submitting updated PMA information, UHP has engaged regularly with the FDA. Through this engagement the company was recently notified that it had been selected as the first medical device application for Premarket Approval (PMA) to be submitted and evaluated using the FDA’s electronic Submission Template and Resource (“eSTAR”) platform. The eSTAR is an interactive, automated PDF form that guides applicants through the process of preparing a comprehensive medical device submission. This template contains (i) content and structure that is complementary to FDA internal review templates, (ii) integration of multiple resources such as process guidance and databases, (iii) guided construction for each submission section and (iv) automatic verification of submitted files. With a standardized eSTAR format, submitters can ensure their submissions are complete, and the FDA can conduct premarket reviews more efficiently to help promote timely approval decisions on new medical devices. For example, the automatic verification process within eSTAR negates the need for a “Refuse to Accept” review, among other time-consuming administrative processes. The eSTAR has been used extensively in medical device applications for 510(k) approval and UHP is honored to have been selected as the first to submit its Premarket Approval application through this FDA resource.
In addition to a more streamlined FDA filing and review process, under a joint pilot program that will test the use of a single eSTAR submitted to both Health Canada and the FDA, the eSTAR will allow UHP to also seek approval from Health Canada which, if received, would allow the company to market its products for human surgical applications in this market.
There can be no assurance that the company’s PMA or Health Canada applications will be approved.
About United Health Products -- UHP develops, manufactures and markets HemoStyp™, a patented Neutralized Regenerated Cellulose hemostatic agent. HemoStyp is an all-natural product designed to control bleeding. UHP currently offers a suite of hemostatic products to the dental, veterinary and emergency medicine markets, and is seeking approval to access the human surgical market.
The company can also be reached by phone or text message at 475.755.1005
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words "believes," "expects," "anticipates" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the company to differ materially from those expressed or implied by such forward-looking statements.
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