Department of Health and Human Services September 9, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 020'' (Recognition List Number: 020), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the University of Pennsylvania (Penn). The purpose of this MOU is to establish terms of collaboration between FDA and Penn focused primarily but not exclusively, in the areas of translational therapeutics, diagnostics, bioinformatics, new clinical trial models, drug/device co-development, and pharmacoepidemiology. Beyond the collaborations in the traditional academic programs for training, research, and outreach, this MOU will also include collaborations with Penn extended partnerships such as the Institute for Translational Medicine and Therapeutics which includes the Children's Hospital of Philadelphia, the Wistar Institute, and the University of Sciences in Philadelphia.