In June of 2002 at a Blood Product Advisory Group meeting Diane Gubernot of FDA’s gave a presentation entitled: “CBER Requirements for Premarket Submissions: In vitro Diagnostic Instrumentation and Software Related to Donor Screening and HIV Diagnostic Assay Systems”.
This presentation asserts that submissions should include documentaton for “major level of concern” from CDRH’s general software submission guidance for HIV screening software. It heavily references many of CDRH’s software references will be used in CBER’s reviews of these types of products.