DiagnosTear Technologies (DTR.CN) has submitted a pre-submission request to the US Food and Drug Administration (FDA) for its TeaRx Red Eye diagnostic test, it said Thursday.
The company prepared and submitted the pre-submission with the support of Hogan Lovells Cadwalader US LLP, the company's US regulatory counsel, said DiagnosTear.
"By engaging with FDA at this stage, we aim to establish a clear regulatory pathway and align our clinical and analytical development program with the Agency's expectations," said DiagnosTear Technologies CEO Shimon Gross.