Unilife has received 510(k) market clearance from FDA for the Unitract 1ml Insulin Syringes assembled at its Lewisberry manufacturing facility. The Unitract range of 1ml syringes allow operators to control the speed of passive (automatic) needle retraction directly from the patient's body into the barrel of the syringe where it is locked in place.
The products help to prevent the transmission of blood-borne diseases such as HIV and hepatitis C via needlestick injuries, aerosol dispersal and syringe reuse. Primary target markets of the products include healthcare facilities, pharmaceutical companies and patients who self-administer prescription medication.
In August 2008, Unilife had secured FDA clearance for the Unitract 1ml Insulin Syringe assembled at the Shanghai facilities of a Chinese manufacturing partner. With Unilife’s FDA-registered Lewisberry facility being considered as a new manufacturing site by the FDA, the company was required to submit an additional 510(k) for US assembled stock.
Unilife expects to immediately file an additional 510(k) with the FDA seeking clearance for the Unitract 1ml Tuberculin (TB) Syringe. FDA clearance of the Unitract 1ml TB Syringe, which is a variant of the Insulin syringe product, will further expand the ability of the company to market its range of safety syringes to US healthcare facilities.
Alan Shortall, CEO of Unilife, said: “With the FDA placing an increasingly stringent focus on approved medical devices, the receipt of clearance for our US assembled syringes further underlines the strength of Unilife’s quality management and production systems.
“We have experienced significant progress with the international rollout of our Unitract 1ml safety syringe over the past year. We believe this most recent FDA clearance now allows Unilife to more aggressively target US customers and further drive market awareness of our leading safety syringe technology. In addition, with the majority of those pharmaceutical and healthcare companies seeking to utilize product assembled at our US facility, we can further accelerate the rollout of this product.”