Cerus Submits First of Three Modules in PMA App Process for INTERCEPT

Cerus Corporation

announced today that it has submitted the first of three modules for its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA), for review of the INTERCEPT Blood System for platelets. The PMA application shell for the platelet system, accepted by the FDA in April, provides for three modular submissions. This enables FDA to review each module separately, and allows the applicant to receive timely feedback to resolve possible deficiencies earlier in the review process when compared to a traditional PMA application. In addition to the PMA for platelets, as of August 30, 2013, Cerus submitted to FDA the third of four modules for its modular PMA application for review of the INTERCEPT Blood System for plasma.