United Health Products submits response letter to FDA

United Health Products provided an update on the company’s FDA Premarket Approval application process. Following the company’s March 21 submission of its PMA application and the FDA’s June 18 “Deficiencies Letter” to the company listing certain questions and comments on various elements of the application, on August 15, UHP submitted a Submission Issue Request to the FDA responding to certain questions and detailing its approach to addressing certain identified deficiencies. The company has requested video conference with the FDA PMA application review team to discuss its responses and proposed solutions to the deficiencies. UHP anticipates the meeting to take place in early September. The FDA’s 180-day application review period, of which approximately 90 days have elapsed, will remain paused while the company engages further with the FDA and addresses any remaining deficiencies.