Australian medical technology company LBT Innovations (ASX:LBT) has updated investors on its 510(k) submission to the US FDA for the APAS Independence with MRSA analysis module.
The company said it has received notification from the FDA that its application for the APAS Independence with MRSA analysis module is on hold pending the provision of additional information.
It said it has attended a teleconference with the FDA to discuss the feedback.
"This was helpful to better understand the FDA’s thinking and assist the Company to diligently prepare a comprehensive response to the FDA as soon as practicable," said LBT Innovations in a statement.
The company said it has 180-calendar days to provide a formal response or the FDA will consider the application withdrawn. It said the specific matters raised by the FDA are commercial-in-confidence but that it expects to lodge a formal response with the FDA within the 180-calendar days.
"It is important to note the issues raised by the FDA do not impact the existing FDA clearance for the APAS Independence with Urine analysis module," it said.
"The matters raised by the FDA do not impact the availability of the MRSA analysis module in other regions, nor likely to impact the current discussions with distributors," it added.
LBT CEO and Managing Director, Brent Barnes, said: “We had a productive call with the FDA today and believe we will be able to address their issues and requests for additional information. At this stage the planning of our response is still a work in progress so we cannot accurately assess the likely timing to resubmit to the FDA.”