The FDA has issued draft guidance on “The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.” The document provides industry and FDA staff with guidelines for developing premarket submissions for artificial pancreas device systems, in particular, the Control-to-Range and Control-to-Target device systems. Although comments on the guidance can be submitted at any time, FDA is requesting that interested parties submit their comments by March 5, 2012. Separately, the FDA has released draft guidance to the industry, particularly blood establishments that collect Whole Blood and blood components for transfusion or for further manufacture (including recovered plasma, Source Plasma, and Source Leukocytes) on the use of FDA-licensed nucleic acid tests (NAT) to screen blood donors for hepatitis B virus (HBV) deoxyribonucleic acid. FDA also provides recommendations for product testing and disposition, donor management, methods for donor requalification, and product labeling. The guidance explains that FDA considers the use of an FDA-licensed HBV NAT to be necessary to reduce adequately and appropriately the risk of transmission of HBV. Comments are due January 27, 2012.