What are the most common factors that delay the BIMO review of a PMA?
An applicant’s failure to submit certain information in the PMA can delay the BIMO review of a PMA. Information that is commonly missing is complete contact information for clinical investigators or Institutional Review Boards (IRBs) , the IRB-approved informed consent documents, the location of where clinical study records are maintained, the study protocol including history of any changes with corresponding date of changes, sample case report forms, or tabulations of data, commonly referred to as “line data,” that support key safety and effectiveness endpoints for each subject entered into the pivotal study(ies ). This data should be sorted by site, then subject, and provided in a standard acceptable electronic format, such as SAS XPORT file format, or a file format mutually acceptable to you and FDA . Another factor that can delay review is the lack of the sponsor’s or investigators’ availability to permit the BIMO inspection. When a PMA or PMA supplement is submitted there is a pre
