The FDA has issued draft guidance on “The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems.”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 Separately, the FDA has released draft guidance to the industry, particularly blood establishments that collect Whole Blood and blood components for transfusion or for further manufacture (including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.
Register Now As you are not an existing subscriber please register for your free daily legal newsfeed service.Register
If you have any questions about the service please contact firstname.lastname@example.org or call Lexology Customer Services on +44 20 7234 0606.
FDA draft guidance on artificial pancreas device systems, hepatitis B screening of blood/blood components
If you are interested in submitting an article to Lexology, please contact Andrew Teague at email@example.com.
"Lexology is a quick and useful indicator of developments in the legal sphere. It alerts me to changes taking place in the legal environment in South Africa that I may not otherwise have spotted or had immediate access...
"Lexology is a quick and useful indicator of developments in the legal sphere. It alerts me to changes taking place in the legal environment in South Africa that I may not otherwise have spotted or had immediate access to as a company lawyer. It definitely serves as a trigger for me to investigate such changes in the legal landscape in South Africa as they may affect my work and that of my employer. I believe that receiving Lexology provides me with a competitive advantage."
Dr Jürgen Fegbeutel
Legal Services Director
BMW (South Africa) (Pty) Ltd