The staffs improved policy, procedures, and outreach activities, which provides the underpinning for a solid review process, and is dedicated to continue this standard as we enter the new millennium. Two submissions are still on backlog status. A pilot program to use the SARP was successful. These SOPs are being implemented in OBRR to improve the effective and timely review of submissions. Guidance for applicants of cell separation and collection devices, leukoreduction filters is under development as well as guidance for manufacturing and stability of blood banking reagents.
Efforts are underway to revise the reviewer guidance for blood bank software.
Additional guidance considered includes reviewer guidance for HIV rapid diagnostic testing and guidance on the use of external controls. Both CBER and CDRH senior staff made presentations. Approximately 70 CBER staff completed this training, which provided an overview of device regulations, application processes and compliance issues. Participants provided evaluations of the training including suggestions for training and workshops on more advanced and specific topics. Nucleic Acid Testing training is scheduled for May and September 2000.