UHP meets with FDA on PMA; manufacturing validation needed for review completion

United Health Products, Inc.

On July 13, 2022, UHP and its consultant met with FDA team to discuss observations from initial PMA review.
FDA indicated validation of certain manufacturing process elements is needed to complete PMA review.
UHP to work expeditiously with manufacturing partner in coming weeks to accomplish remaining tasks.
No assurance that PMA application will be approved.

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