Department of Health and Human Services July 27, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined the regulatory review period for ATS Open Pivot Bileaf Heart Valve and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry,'' dated July 2005. The draft guidance document provides information for blood and plasma establishments, manufacturers, and testing laboratories that are implementing a licensed method for NAT on pooled or individual samples of human blood and blood component donations for HIV-1 ribonucleic acid (RNA) and HCV RNA. The draft guidance document is intended to encourage more effective testing of whole blood and blood component samples, and improved product and donor management based on the results of NAT and concurrent serologic testing for markers of HIV and HCV infection on donated whole blood and blood components.