The system’s PMA application shell, which outlines the structure, content and timing of each PMA module, has been accepted by the FDA with three modular submissions.
Under a modular approach, the FDA reviews each module separately and provides the applicant with timely feedback, meaning issues can potentially be resolved earlier in the review process.
The first module is scheduled for submission at the end of September 2013.
Cerus regulatory affairs, quality and clinical senior vice president Carol Moore said the platelet PMA shell proposal was designed to align with the company’s ongoing modular PMA submissions for its plasma system, giving a target completion date for all three platelet modules by March 2014.
“With the scheduled submission of the final Intercept plasma module planned for the fourth quarter of this year, we have the possibility of receiving US approvals for both products as soon as the second half of 2014,” Moore said.
Cerus president and CEO William ‘Obi’ Greenman said the FDA’s acceptance of the PMA timeline means the company may be able to launch Intercept platelets and plasma almost simultaneously in the US.
“Cerus is focused on succeeding at this goal, and maximising the global impact we believe a US market entry can create,” Greenman said.